FDA’s Role in the Medical Product Supply Chain and Considerations During COVID-19

FDA’s Role in the Medical Product Supply Chain and Considerations During COVID-19

FDA’s Role in the Medical Product Supply
September 1, 2020
Chain and Considerations During COVID-19
Victoria R. Green
The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply
Analyst in Health Policy
chain globally and domestically. Although concerns about the U.S. medical product supply chain

predate the emergence of COVID-19, the ongoing pandemic has underscored the importance of
Agata Dabrowska
understanding the supply chain—in particular, U.S. reliance on foreign sources of medical
Analyst in Health Policy
products and the federal government’s ability to oversee the supply chain and mitigate future

disruptions.
Kate M. Costin
The Food and Drug Administration (FDA), within the Department of Health and Human Services
Research Librarian
(HHS), is the federal agency responsible for ensuring the safety and effectiveness of medical

products—drugs and medical devices—marketed in the United States. The FDA therefore plays a
critical role in overseeing aspects of the U.S. medical product supply chain. Drug and medical

device (“device”) manufacturers are subject to FDA-mandated reporting requirements related to
the supply chain. For example, establishments that manufacture drugs and devices are required to register with FDA and must
report various manufacturing-related information to the agency. These requirements apply to both domestic and foreign
establishments that import drugs and devices into the United States. However, concerns have been raised that certain
manufacturers, such as those producing medical products or components that are not imported directly into the United States,
may not be registered with FDA. This potential blind spot may limit the agency’s ability to oversee the medical product
supply chain and monitor the entities manufacturing such products for the U.S. market.
In response to concerns about FDA regulation of drugs and devices in the global supply chain, Congress has introduced and
passed legislation to help regulators, stakeholders, and the public better understand the medical product supply chain both
during and beyond public health emergencies. The recently enacted Coronavirus Aid, Relief, and Economic Security Act
(CARES Act; P.L. 116-136), for example, expanded drug listing and reporting requirements to help quantify for regulators
the volume of finished drug products and active pharmaceutical ingredients (APIs) manufactured domestically and abroad for
the U.S. market. The CARES Act also provided FDA the explicit authority to require certain device manufacturers to report
interruptions or discontinuances in manufacturing during public health emergencies. More broadly, the CARES Act requires
the National Academies of Science, Engineering, and Medicine (NASEM) to examine and report on the security of the U.S.
medical product supply chain, including U.S. dependence on critical drugs and devices from other countries.
However, some stakeholders and Members of Congress contend that issues remain regarding the medical product supply
chain in the context of FDA’s existing authority. These issues include
 gaps or loopholes in reporting requirements to FDA, which may limit the agency’s ability to oversee the
medical product supply chain;
 limitations in currently available supply chain data, which make it challenging to determine the extent of
U.S. reliance on foreign medical product manufacturers; and
 a lack of transparency in the medical product supply chain, which may contribute to product shortages and
pose a risk to national security.

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Contents
Background ..................................................................................................................................... 1
Federal Role in Overseeing the Medical Supply Chain ............................................................ 1
Scope of This Report ................................................................................................................. 2
Registration and Listing Requirements for Drugs and Devices ...................................................... 3
Establishment Registration Requirements ................................................................................ 3
Listing Requirements ................................................................................................................ 5
Drugs ................................................................................................................................... 6
Devices ................................................................................................................................ 7
Submission of Supply Chain Information as Part of Marketing Authorization ............................... 8
Drugs and Biologics .................................................................................................................. 9
Devices .................................................................................................................................... 10
Submission of Supply Chain Information Upon Importation ........................................................ 11
Collection of Supply Chain Information as Part of Facility Inspections ....................................... 13
Current Good Manufacturing Practices (CGMPs) .................................................................. 14
Types of Facility Inspections................................................................................................... 14
Records from Facility Inspections........................................................................................... 15
Other Supply Chain Reporting Requirements ............................................................................... 16
Manufacturing Interruptions, Discontinuances, and Shortages ............................................... 17
Drugs ................................................................................................................................. 17
Devices .............................................................................................................................. 18
Shortage Lists .......................................................................................................................... 18
Drug Supply Chain and Security ............................................................................................. 19
Select Issues for Congress ............................................................................................................. 19
Gaps in Reporting Requirements and Limits to FDA Oversight ............................................. 20
Limitations of Currently Available Data ................................................................................. 22
API .................................................................................................................................... 22
Other Medical Product Data ............................................................................................. 23
Lack of Transparency in the Supply Chain ............................................................................. 24
Concluding Observations .............................................................................................................. 26

Appendixes
Appendix A. Selected Laws Authorizing and Amending Registration and Reporting
Requirements .............................................................................................................................. 28
Appendix B. Selected Medical Product Supply Chain Legislation Introduced in the 116th
Congress ..................................................................................................................................... 31
Appendix C. Selected Medical Product Supply Chain Resources ................................................ 37
Appendix D. Acronyms Used in this Report ................................................................................. 40

Contacts
Author Information ........................................................................................................................ 41
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FDA’s Role in the Medical Product Supply Chain and Considerations During COVID-19

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FDA’s Role in the Medical Product Supply Chain and Considerations During COVID-19

Background
The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply
chain globally and domestically. Although certain concerns about the U.S. medical product
supply chain predate the emergence of COVID-19, the ongoing pandemic has made addressing
those concerns and understanding the supply chain a more urgent priority. Of particular concern
for some are the United States’ reliance on foreign sources of medical products and the federal
government’s ability to oversee the supply chain and mitigate future disruptions.
Federal Role in Overseeing the Medical Supply Chain
The Food and Drug Administration (FDA), within the Department of Health and Human Services
(HHS), is the federal agency responsible for ensuring the safety and effectiveness of medical
products, which include drugs, biological products (biologics), and medical devices marketed in
the United States. Small molecule, chemically synthesized drugs and medical devices are
approved or cleared by FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA), whereas
biologics—therapeutics derived from living organisms—are licensed by FDA under the Public
Health Service Act (PHSA). For the purpose of this report, unless otherwise noted, the term drugs
generally includes finished drug products, active pharmaceutical ingredients (APIs or drug
substances),1 as well as biologics, which are subject to most FFDCA drug requirements. Medical
devices are referred to as devices, consistent with the term’s definition in the FFDCA.2
As the federal regulator of drugs and devices, FDA plays a critical role in overseeing aspects of
the U.S. medical product supply chain. Drug and device manufacturers are required, by law, to
report to FDA certain supply chain-related information, with some exceptions for emergency
circumstances.3 For example, establishments that manufacture drugs and devices are required to
register with FDA and list the drugs and devices they manufacture for U.S. commercial
distribution. This registration helps FDA maintain a catalog of all drugs, biologics, and devices in
commercial distribution in the United States.4 FDA relies on establishment registration and listing
information to carry out various programs and activities, including establishment inspections,
postmarketing surveillance, recalls, drug quality reports, adverse event reports, monitoring of
drug and device shortages and availability, supply chain security, and identification of products
marketed without an approved application.5

1 FDA regulations define a finished drug product to mean a finished dosage form (e.g., tablet, capsule, or solution) that
contains at least one API and typically “in association with other ingredients in finished package form suitable for
distribution to pharmacies, hospitals, or other sellers or dispensers of the drug product to patients or consumers.” An
API refers to “any substance that is intended for incorporation into a finished drug product and is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or
to affect the structure or any function of the body. Active pharmaceutical ingredient does not include intermediates
used in the synthesis of the substance.” An unfinished drug refers to an API either alone or with one or more other
ingredients but does not include finished drug products. 21 C.F.R. §207.1.
2 FFDCA §201(h); 21 U.S.C. §321(h).
3 For more information on emergency use authorization (EUA), see CRS In Focus IF10745, Emergency Use
Authorization and FDA’s Related Authorities.
4 FDA, “CY 2018 Annual Report on Inspections of Establishments,” https://www.fda.gov/media/123480/download.
5 FDA, “Drugs Intended for Human Use That Are Improperly Listed Due to Lack of Annual Certification or
Identification of a Manufacturing Establishment Not Duly Registered With the Food and Drug Administration; Action
Dates,” 84 Federal Register 40417-40419, August 14, 2019. See also, FDA, “Implementation of Device Registration
and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of
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Although registration and listing requirements apply to both domestic and foreign establishments
that import drugs and devices into the United States, concerns have been raised that certain
entities that manufacture drugs or their ingredients may not be registering with FDA. For
example, according to October 2019 congressional testimony from Dr. Janet Woodcock, the
Director of FDA’s Center for Drug Evaluation and Research (CDER),
CDER has limited information about API suppliers for products that do not need an
approved application from FDA to be marketed, such as compounded and OTC [over-the-
counter] monograph drugs. API suppliers for such products may not register their facility
with FDA if they are sending material to a drug product manufacturer outside the United
States to make the FDF [finished dosage form], which is then sold in the United States.6
These potential gaps in registration information may limit FDA’s ability to oversee the entire
supply chain and monitor the entities manufacturing drugs for the U.S. market.
In response to these concerns, Congress has passed legislation to help regulators, stakeholders,
and the public better understand the medical product supply chain. The recently enacted
Coronavirus Aid, Relief, and Economic Security Act (CARES Act; P.L. 116-136), for example,
expanded drug listing and reporting requirements to help quantify for regulators the amount of
finished drug products and APIs manufactured domestically and abroad for the U.S. market, and
provided FDA the explicit authority to require certain device manufacturers to report interruptions
or disruptions in manufacturing during a public health emergency. More broadly, the CARES Act
requires the National Academies of Science, Engineering, and Medicine (NASEM) to examine
and report on the security of the U.S. medical product supply chain, including U.S. dependence
on critical drugs and devices from other countries.
Scope of This Report
In light of recent legislation and ongoing congressional interest regarding the medical product
supply chain, this report provides an overview of current FDA-mandated supply chain-related
reporting requirements that apply to drug and device manufacturers. Specifically, the report
 describes the registration and listing requirements that apply to domestic and
foreign drug and device manufacturers;
 describes marketing authorization, importation, and manufacturing requirements
related to FDA’s monitoring of the supply chain;
 provides a brief overview of the types of facility inspections conducted by FDA
and the supply-chain related information available to the agency during
inspections; and
 discusses further issues for congressional consideration.
Appendix A includes a legislative history of laws that have authorized and amended the
registration and reporting requirements described in this report, Appendix B provides an
overview of legislative proposals introduced in the 116th Congress related to the medical product

2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration
Amendments Act of 2007,” 77 Federal Register 45927-45944, August 2, 2012.
6 FDA, Testimony of Dr. Janet Woodcock, Director the Center for Drug Evaluation and Research, Safeguarding
Pharmaceutical Supply Chains in a Global Economy, before the U.S. Congress, House Committee on Energy and
Commerce, Subcommittee on Health, 116th Cong., 1st sess., October 30, 2019, https://www.fda.gov/news-events/
congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019, (hereinafter, FDA,
Testimony of Dr. Janet Woodcock, “Safeguarding Pharmaceutical Supply Chains in a Global Economy.”).
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supply chain, Appendix C lists medical product supply chain resources, and Appendix D
includes a list of acronyms used in this report.
It is not the purpose of this report to compare and contrast FDA drug and device reporting
requirements. Rather, the purpose is to broadly describe, in the context of supply chain
transparency, existing reporting requirements for entities that manufacture drugs and devices for
the U.S. market and to identify gaps in those requirements. This report does not describe every
reporting requirement (e.g., adverse event reports); instead, it aims to provide a picture of the data
and information that must be submitted to FDA to enable the agency to monitor the medical
product supply chain.
Registration and Listing Requirements for Drugs
and Devices
FDA’s authority to regulate drugs and devices derives from the FFDCA. The FFDCA imposes
various requirements on entities engaged in the ‘‘manufacture, preparation, propagation,
compounding, or processing’’ (hereinafter referred to as manufacture) of drugs and devices.7 The
FFDCA and FDA regulations require establishments to submit specific information to the HHS
Secretary (FDA, by delegation of authority) about the drugs and devices they manufacture for the
U.S. market. This requirement is distinct from other requirements, such as marketing
authorization (discussed in the “Submission of Supply Chain Information as Part of Marketing
Authorization” section), and the information gained from registration and listing allows FDA to
carry out various programs and activities, including establishment inspections, postmarketing
surveillance, and product recalls, among other things. Such information must be submitted
electronically (with certain exceptions)8 and is generally publicly available.9 However, FDA does
not disclose which products are made at which establishments.
Establishment Registration Requirements
Domestic and foreign establishments that manufacture drugs and devices must be registered with
FDA. Domestic establishments are those located in a state or territory of the United States, the
District of Columbia, and the Commonwealth of Puerto Rico;10 foreign establishments are those
located in foreign countries and that import or offer for import drugs and devices into the United
States. Generally, facilities that manufacture the source or raw materials used in the
manufacturing of drugs or devices (e.g., starting materials used to make an API or a valve in a
ventilator) are not required to register with FDA.11

7 As used in this report, the term manufacture refers to all activities that trigger establishment registration obligations
under FFDCA Section 510 and in FDA regulation at 21 C.F.R. Part 207 for drugs (including drug repacking,
relabeling, and salvaging) and 21 C.F.R. Part 807 for devices (including device assembly and repackaging).
8 FFDCA §510(p); 21 U.S.C. §360(p).
9 FDA, “Drug Establishments Current Registration Site,” https://www.fda.gov/drugs/drug-approvals-and-databases/
drug-establishments-current-registration-site. FDA, “Establishment Registration & Device Listing,”
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm.
10 21 C.F.R. §207.1.
11 21 C.F.R. §§207.13 and 807.65. See also FDA, “Electronic Drug Registration and Listing Instructions,”
https://www.fda.gov/drugs/drug-registration-and-listing-system-drls-and-edrls/electronic-drug-registration-and-listing-
instructions, and “Who Must Register, List, and Pay the Fee,” September 27, 2018, https://www.fda.gov/medical-
devices/device-registration-and-listing/who-must-register-list-and-pay-fee.
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With respect to domestic facilities, a person who owns or operates an establishment that
manufactures drugs or devices must register with FDA and submit specified information. The
registration requirement applies regardless of whether the manufactured drug or device is
intended for U.S. commercial distribution.12 A person must register an establishment upon first
engaging in the manufacture of a drug or device, and the establishment must be registered
annually thereafter between October 1 and December 31.13 Registrants must immediately register
any additional establishments they own in which a drug or device is initially manufactured.14 For
drugs, the registration must include the name of the owner or operator of each establishment; each
establishment’s name, physical address, and telephone number(s); all names of the establishment;
the registration number, if assigned by FDA; the unique facility identifier (UFI); all types of
operations performed at the establishment; and specified contact information.15 FDA regulations
further specify that registrants must register each domestic establishment no later than five
calendar days after beginning drug manufacturing. For devices, the registration must include the
name, place of business, specified contact information, and all such establishments that engage in
the manufacture of a device or devices.16 FDA regulations specify that registrants must initially
register each domestic (and foreign) establishment no later than 30 days after beginning any
process of device manufacturing.
With respect to foreign facilities, as with domestic facilities, a person who owns or operates an
establishment in a foreign country that manufactures drugs or devices for import into the United
States must register with FDA upon engaging in the manufacture of a drug or device, and the
establishment must be registered annually thereafter between October 1 and December 31.17
Registrants generally must submit the same information that is required for domestic facilities.
However, registration information for a foreign establishment must also include the name,
mailing address, telephone number, and email address of the U.S. agent of each establishment,
each importer of the drug in the United States that is known to the establishment, and each person
who imports or offers for import the drug to the United States.18 Similarly, for devices, the
registration must include the name and place of business of the establishment, the name of the
U.S. agent for the establishment, the name of each importer of the device in the United States
known to the establishment, and the name of each person who imports or offers for import the
device to the United States.19 Foreign establishments are required to update registration

12 FDA, “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including
Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs,” 81 Federal Register 60169,
August 31, 2016, and FDA, “Implementation of Device Registration and Listing Requirements Enacted in the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and
Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007,” 77 Federal
Register 45941, August 2, 2012.
13 FFDCA §510(b) and (c) [21 U.S.C. §360(b) and (c)].
14 FFDCA §510(d) [21 U.S.C. §360(d)].
15 FFDCA §510(b)(1) [21 U.S.C. §360(b)(1)] and 21 C.F.R. Part 207 Subpart B. FDA, Guidance for Industry,
Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration, November 2014,
https://www.fda.gov/media/89926/download.
16 FFDCA §510(b)(2) [21 U.S.C. §360(b)(2)]; 21 C.F.R. Part 807 Subpart B.
17 FFDCA §510(i) [21 U.S.C. §360(i)].
18 FFDCA §510(i)(1)(A)(i) [21 U.S.C. §360(i)(1)(A)(i)] and 21 C.F.R. Part 207 Subpart B. FDA, “Electronic Drug
Registration and Listing Instructions,” https://www.fda.gov/drugs/drug-registration-and-listing-system-drls-and-edrls/
electronic-drug-registration-and-listing-instructions.
19 FFDCA §510(i)(1)(A)(ii) [21 U.S.C. §360(i)(1)(A)(ii)] and 21 C.F.R. Part 807 Subpart C.
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information to reflect any changes in a U.S. agent’s name, address, or phone number within 10
business days.
FDA regulations include additional requirements that apply to both domestic and foreign
establishments. For example, for both drugs and devices, per agency regulations, if covered
operations are conducted at more than one establishment under common ownership and control,
the parent, subsidiary, or affiliate company may submit registration information for all
establishments. FDA regulations further require registrants of drug establishments to update their
registration information no later than 30 calendar days after certain changes are made: after
closing or selling an establishment; after changing an establishment’s name or physical address;
or after changing the name, mailing address, telephone number, or email address of the official
contact or the United States agent.20 Similarly, for devices, registrants are required to update their
registration no later than 30 calendar days after changing the name, mailing address, or website
address (if any) of the device establishment; the name, address, phone number, fax number, and
email address of the owner or operator; the name, address, phone number, fax number, and email
address of the establishment’s official correspondent; or all trade names used by the
establishment.21
Certain entities are exempt from the registration requirements, including
 pharmacies;
 licensed health care practitioners;
 persons who manufacture drugs or devices not for sale but solely for research,
teaching, or chemical analysis;
 wholesale distributors of devices; and
 other classes of persons exempted by FDA by regulation.22
Specific to drugs, for example, manufacturers of “harmless inactive ingredients such as
excipients, colorings, flavorings, emulsifiers, lubricants, preservatives, or solvents that become
components of drugs” are exempt from registration requirements.23 In device regulation, for
example, manufacturers of raw materials and components that are distributed to a finished
device24 manufacturer and manufacturers of devices for veterinary purposes are exempted from
registration.25
Listing Requirements
Every person who registers with FDA, must, at the time of registration, file with FDA a list of
drugs and devices—by their established and proprietary names—being manufactured for
commercial distribution. As with registration, information gained from listing allows FDA to
carry out various activities, such as completing adverse event reports, monitoring drug and device

20 21 C.F.R. §207.29.
21 21 C.F.R. §807.25(b).
22 FFDCA §510(g) [21 U.S.C. §360(g)]; 21 C.F.R. Part 207.
23 21 C.F.R. §207.13. In guidance, FDA defines excipient to mean any inactive ingredients that are intentionally added
to therapeutic and diagnostic products. FDA, Guidance for Industry: Nonclinical Studies for the Safety Evaluation of
Pharmaceutical Excipients, May 2005, https://www.fda.gov/media/72260/download.
24 Pursuant to 21 C.F.R. §820.3, a finished device is defined as any device or accessory to any device that is suitable for
use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
25 21 C.F.R. §807.65.
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shortages and availability, and identifying products that are marketed without an approved
application, among other things. Drug and device requirements are described below.
Drugs
Registrants must “list” each drug (i.e., finished drug and API) manufactured at their
establishments for commercial distribution upon establishment registration; the listing
information must be reviewed and updated biannually. More specifically, each person who
registers a drug manufacturing establishment with FDA under FFDCA Section 510 must submit,
within three calendar days of initial registration, a list of drugs that it manufactures for
commercial distribution.26 Registrants must also list, at the time of annual establishment
registration—between October 1 and December 31—any drugs manufactured for commercial
distribution that had not been listed previously.27
The FFDCA and FDA regulations specify what information must be submitted as part of drug
listing. Some of these requirements differ depending on whether the drug is subject to the
approval requirements under FFDCA Section 505 (or FFDCA Section 512 for new animal drugs),
whether the drug is exempt from approval, and whether the drug is available by prescription only
or over-the-counter (OTC).28 For example, for a drug subject to approval via a new drug
application (NDA) or abbreviated new drug application (ANDA), the list must include a reference
to the authority for marketing the drug (e.g., the approved U.S. application number).29 For a drug
exempt from approval (e.g., an OTC monograph drug), the list must include a brief statement
explaining how the registrant determined that the drug is not subject to approval; certain labeling
information, which varies depending on whether the drug is by prescription only or OTC; and a
quantitative listing of the drug’s active ingredients. As part of the listing information for all drugs,
the registrant must provide information about the excipients in the drug, including the name and
place of business of each manufacturer of such excipient. In addition, FDA may require
registrants to submit a list of each drug product being manufactured for commercial distribution
that contains a particular ingredient.30
FDA regulations further require a registrant to provide, as part of drug listing, the name and UFI
of every other establishment where manufacturing is performed for the drug and the type of
operation performed at each establishment.31 A registrant must also obtain for each drug subject to
the listing requirements a national drug code (NDC) from FDA.32 The registrant must propose a
new NDC if certain changes are made to a drug after its initial marketing (e.g., a change in its
name, API, or dosage form). The NDC is a universal product identifier for human drugs
manufactured for commercial distribution. The listing of a drug is not indicative of marketing
approval, as FDA does not review or approve unfinished drugs or APIs. Thus, a drug may have an
NDC but may not be FDA-approved.33

26 FFDCA §510(j)(1) [21 U.S.C. §360(j)(1)]; 21 C.F.R. §207.45.
27 21 C.F.R. §207.57.
28 FFDCA §510(j)(1) [21 U.S.C. §360(j)(1)].
29 FDA regulations extend this requirement to biologics licensed (i.e., “approved”) under a biologics license application
or BLA.
30 FFDCA §510(j)(3); 21 U.S.C. §360(j)(3).
31 21 C.F.R. Part 207 Subpart D. FDA regulations differentiate between what listing information must be provided by a
registrant that manufactures drugs, repacks or relabels drugs, and salvages drugs.
32 21 C.F.R. Part 207 Subpart C.
33 21 C.F.R. Part 207 Subpart C. See also FDA, “National Drug Code Directory,” https://www.fda.gov/drugs/drug-
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Registrants must review and update their drug listing information biannually—once in June and
once in December of each year. During this biannual review, a registrant must (1) provide a list of
drugs introduced for commercial distribution that were not included on any previously submitted
list; (2) report if the manufacture of any previously listed drug has been discontinued since the
last report (or resumed if previously discontinued); and (3) report any material change to
previously submitted information. If there are no changes to report in June or December, the
registrant must certify that no changes subject to reporting have occurred since the last report.34
Registrants are encouraged, but not required, to submit listing information at the time of making
any change affecting information previously submitted.
Each person who registers with FDA under FFDCA Section 510 must report annually on the
amount of each listed drug manufactured for commercial distribution. FDA may require that this
information be submitted at the time a public health emergency is declared under Section 319 of
the Public Health Service Act. Certain biologics may be exempted from this reporting
requirement if FDA determines that applying such requirements to biologics is not necessary to
protect the public health.35
Devices
Similar to drug requirements, registering a device establishment with FDA requires registrants to
file a list of all devices being manufactured for commercial distribution. Device listing generally
occurs at two times: (1) at initial registration and listing, which must occur within 30 days of
commencing device manufacturing, and (2) at annual registration and listing, which occurs
between October 1 and December 31 of each year. A registrant may—but is not required—to
make changes to listing information at other times, such as when a device is first introduced into
commercial distribution.36
Specified information is required at the time of initial listing. A brief explanation about why the
device is not being listed as a drug must accompany each device in the list.37 In addition, a
reference to the authority under which certain devices are being marketed (e.g., an FDA-assigned
premarket application number), including the reasoning for not marketing devices under certain
authorities, is required.38 A description of each activity or process that contributes to the device
(e.g., manufacturing, sterilization) must be provided, including which part of the process occurred
at which establishment under the owner or operator’s control.39 Regarding labeling and
advertising information, listings for restricted devices—those that can be sold only under
authorization from a licensed health care provider or under conditions specified in regulation40—
must include a copy of all labeling and a representative sampling of advertisements. If requested

approvals-and-databases/national-drug-code-directory.
34 FFDCA §510(j)(2) [21 U.S.C. §360(j)(2)] and 21 C.F.R. §207.57.
35 FFDCA §510(j)(3)(A) [21 U.S.C. §360(j)(3)(A)], as added by §3112(e) of the CARES Act (P.L. 116-136).
36 FDA, “When to Register and List,” December 23, 2017, https://www.fda.gov/medical-devices/device-registration-
and-listing/when-register-and-list.
37 Per FDA guidance, “Conceptually, all FDA-regulated medical products meet the definition of “drug” under section
201(g) of the FD&C Act, due to the broader scope of the drug definition.” For a medical product to meet the definition
of a device under the FFDCA, it must meet specified conditions. For more information, see FDA, Guidance for
Industry and FDA Staff: Classification of Products as Drugs and Devices & Additional Product Classification Issues,
September 2017, https://www.fda.gov/media/80384/download.
38 FFDCA §510(j)(1); 21 U.S.C. §360(j)(1).
39 21 C.F.R. §807.25(g).
40 FFDCA §520(e); 21 U.S.C. §360j(e).
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by FDA for a good cause, a copy of all advertisements for the restricted device must be
submitted. For all other devices, the label and package insert for a device and a representative
sampling of any other labeling must be submitted.41
Each registrant must review and submit additional device listing information on an annual basis
between October 1 and December 31. As with drug requirements, registrants must (1) provide a
list of devices introduced for commercial distribution that were not included on any previously
submitted list; (2) report if the manufacture of any previously listed device has been discontinued
since the last report (or resumed if previously discontinued); and (3) report any material change to
previously submitted information.42 Registrants must maintain in a historical file any material
changes to labeling or advertisements made after the initial listing, and must maintain this file in a
secure location, with additional storage requirements specified in regulation.43
Submission of Supply Chain Information as Part of
Marketing Authorization
With limited exceptions, a drug, biologic, or device may not be marketed in the United States
unless it has been authorized for marketing (i.e., approved, licensed, or cleared) by FDA. This
marketing authorization requirement applies regardless of whether a product is manufactured
domestically or in a foreign country. As mentioned above, for drugs and some devices, this
requirement is distinct from establishment registration and product listing.44 The FFDCA and
FDA regulations require that certain information about where a medical product is manufactured
be submitted to FDA as part of the drug, biologic, and device approval, licensure, and clearance
processes.45 In addition, the FFDCA and FDA regulations impose postmarket reporting
requirements that apply to holders of approved regulatory submissions. Because drugs and
biologics are approved under separate mechanisms, this section differentiates between
requirements for the two medical product types.
To market a new drug, the sponsor (typically the manufacturer) must submit to FDA an NDA
demonstrating that the drug is safe and effective for its proposed use.46 In the case of a generic
drug, the sponsor must submit an ANDA. Although most drugs are subject to premarket approval
through the NDA or ANDA process, there are some exceptions; for example, most OTC drugs are
not covered by an approved NDA or ANDA and may be marketed by complying with a
monograph.47 To market a new biologic, the sponsor must submit to FDA a biologics license

41 FFDCA §510(j)(1)(B); 21 U.S.C. §360(j)(1)(B).
42 FFDCA §510(j)(2) [21 U.S.C. §360(j)(2)] and 21 C.F.R. §807.22(b)(3) and §807.28.
43 21 C.F.R. §807.26.
44 For devices subject to premarket review, the device must be cleared or approved before an establishment can register
and list the device. See FDA, “When to Register and List,” December 2017, https://www.fda.gov/medical-devices/
device-registration-and-listing/when-register-and-list.
45 Labeling included on drug and device packaging is also included as a part of a premarket application reviewed by
FDA prior to marketing authorization.
46 FFDCA §505 [21 U.S.C. §355].
47 A monograph establishes conditions—active ingredient(s) and related conditions (e.g., dosage level, combination of
active ingredients, labeled indications, warnings and adequate directions for use)—under which an OTC drug in a given
therapeutic category (e.g., sunscreen, antacid) is considered generally recognized as safe and effective (GRASE) for
use. See the section “Subtitle F—Over-the-Counter Drugs” in CRS Report R46334, Selected Health Provisions in Title
III of the CARES Act (P.L. 116-136).
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application (BLA) demonstrating that the biologic and the facilities in which it is manufactured
meet standards to ensure its safety, potency (i.e., effectiveness), and purity.48
Most medical devices must be reviewed by FDA prior to marketing; the most common premarket
review mechanisms are premarket notification (i.e., 510(k)) and premarket approval (PMA). The
applicable premarket review mechanism depends on the regulatory class of the device—FDA’s
categorization of devices based on the risk they pose to the consumer. The three regulatory
classes of medical devices with different applicable requirements are class I (low risk), class II
(moderate risk), and class III (high risk). Certain class I devices (e.g., surgical gloves) and most
class II devices (e.g., surgical masks, ventilators) are subject to premarket notification via a
510(k), in which manufacturers are required to submit specified information to FDA at least 90
days prior to marketing.49 To receive a 510(k) clearance, a manufacturer must demonstrate that
the device proposed to be marketed is substantially equivalent to a device already on the market
(i.e., predicate device). To market and receive approval for a class III device, a sponsor must
submit a PMA application demonstrating that the device provides reasonable assurance of safety
and effectiveness.50
Drugs and Biologics
For drugs that are subject to premarket approval—the vast majority of prescription drugs and
some nonprescription (OTC) drugs—information about the API and finished drug manufacturing
facilities must be provided as part of an NDA, ANDA, or BLA. In particular, an NDA or ANDA
must include, as part of the chemistry, manufacturing and controls section of the application, the
name and address of the manufacturer of the drug substance (i.e., API) and the name and address
of each manufacturer of the drug product (i.e., finished drug).51 Similarly, a BLA must include the
address of each location involved in the manufacture of a biologic.52 An application holder is
required to submit to FDA a supplemental submission to reflect any change(s) to the “drug
substance, drug product, production process, quality controls, equipment, or facilities that has a
substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency
of the drug product as these factors may relate to the safety or effectiveness of the drug
product.”53 For drugs that do not require premarket approval (e.g., compounded drugs or OTC
monograph drugs), manufacturers are not subject to these requirements.
Holders of approved applications must submit certain supply chain information to FDA once the
product is on the market. For example, FDA regulations require an approved NDA or ANDA
holder to submit in annual reports, among other things, information about the quantity of the drug
product (i.e., finished drug) distributed under the approved application, including the drug
quantity distributed to distributors. The information must include the total number of dosage units
of each strength or potency distributed and the quantities distributed for domestic and foreign
use.54 For biologics, information about the quantity of the product distributed under an approved
BLA, as specified, must be submitted to FDA in six-month increments or in another time frame

48 PHSA §351 [42 U.S.C. §262]. See also CRS Report R44620, Biologics and Biosimilars: Background and Key
Issues.
49 FFDCA §510(k); 21 U.S.C. §360(k).
50 FFDCA §515(k); 21 U.S.C. §360e.
51 21 C.F.R. §314.50(d)(1) and §314.94(a)(9).
52 21 C.F.R. §601.2(a).
53 21 C.F.R. §314.70. See also FFDCA §506A [21 U.S.C. §356a], 21 C.F.R. §314.97 and §601.12.
54 21 CFR §314.81.
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determined by the agency.55 Reporting distribution data under an NDA, ANDA, or BLA is
separate from that in FFDCA Section 510 requiring each person who registers with FDA to report
annually on the amount of each drug manufactured for commercial distribution (see the “Drugs”
section of this report).
FFDCA Section 506I requires the holder of an approved NDA or ANDA (but not BLA) to notify
FDA of any changes to the marketing status of a drug.56 The holder of an approved NDA or
ANDA must notify FDA in writing six months before withdrawing an approved drug from sale
(or as soon as practicable) and must notify FDA within six months of approval if the drug will not
be available for sale within six months of approval. This requirement is separate from the one in
FFDCA Section 510(j) that each registrant report to FDA in the biannual drug listing information
if the manufacture of any previously listed drug has been discontinued since the last report.
In addition, FDA obtains information about facilities that manufacture generic drugs, pursuant to
requirements under the Generic Drug User Fee Amendments (GDUFA). Under GDUFA, generic
drug manufacturers are subject to three types of facility fees that must be paid annually: (1) an
API facility fee, (2) a finished dosage form (FDF) facility fee, and (3) a contract manufacturing
organization (CMO) facility fee.57 Facility owners incur a fee if their facility is referenced in an
approved generic drug submission (an ANDA) and the facility is engaged in manufacturing or
processing an API or FDF. The owner of such facility must submit certain identification
information to FDA, including whether the facility manufactures an API, FDF, or both, and
whether it is located in the United States.58 FDA publishes on its website several lists of facilities
that are subject to GDUFA, including a list of facilities that have paid the fees, as well as those on
an arrears list for failing to pay.59 Brand-name drugs, biologics, and biosimilars are not subject to
establishment fees under their respective user fee programs.60
Devices
Fewer explicit FDA requirements exist for devices than for drugs regarding the inclusion of
supply chain information in premarket applications for marketing, particularly regarding the
disclosure of location of facilities. The FFDCA and FDA regulations for PMA submissions do not
require that the name and address of each manufacturer involved in the production of the device
be included in the application. Rather, PMA regulations specify that the name and address of the
applicant must be included in the PMA submission; if the applicant is a foreign establishment, an
authorized representative must sign the application and include the representative’s name and
address in the United States.61 Similarly, statute and regulations for 510(k) submissions do not
require that each manufacturer involved in the production of the device be identified in the

55 21 CFR §600.81.
56 FFDCA §506I [21 U.S.C. §356I], added by Section 804 of FDARA (P.L. 115-52).
57 FFDCA §744B(a)(4) [21 U.S.C. §379j-42(a)(4)].
58 FFDCA §744B(f) [21 U.S.C. §379j-42(f)].
59 FDA, Generic Drug User Fee Amendments; see “User Fee Lists” https://www.fda.gov/industry/fda-user-fee-
programs/generic-drug-user-fee-amendments.
60 Brand-name drugs and biologics are subject to the Prescription Drug User Fee Act (PDUFA), and biosimilar
biologics are subject to the Biosimilar User Fee Act (BsUFA). Neither PDUFA nor BsUFA require payment of an
establishment fee. For additional information, see CRS Report R44750, FDA Human Medical Product User Fee
Programs: In Brief.
61 21 C.F.R. §814.20.
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submission. Instead, the name and address of the individual preparing the submissions is
included.62
If a manufacturer makes certain changes to a cleared or approved device, FDA needs to be
notified via a new 510(k) submission63 or a PMA supplement,64 respectively. A PMA supplement
would need to be submitted if a different establishment—whether it is domestic or foreign—is
being used to manufacture the device, but the regulations do not specify requiring other
information about the establishment (e.g., address of establishment, manufacturing capabilities).65
Statute, regulation, and FDA guidance do not explicitly state that a change in location of
manufacturing would trigger a new 510(k). However, a new 510(k) would be triggered by a
significant change in method of manufacture or manufacturing process that could affect the safety
and effectiveness of the device.66 Regardless, FDA generally obtains information about a new
device facility through registration and listing.
Regarding postapproval requirements, FDA requires devices authorized under a PMA to report
certain information annually to the agency. These annual reporting requirements do not apply to
devices subject to 510(k) clearance or those exempt from premarket review. While the
postapproval PMA report is not required to include a discussion of location of manufacturing,
certain distribution information must be included. For example, in approval orders issued after
August 1, 2009, FDA requires applicants to provide the number of devices shipped or sold, or in
the case of device implants, the number of devices implanted.67
FDA also obtains information about device facilities pursuant to requirements under the Medical
Device User Fee Amendments (MDUFA). Under MDUFA, each establishment that intends to
distribute a device commercially is required to pay a user fee at the time of registration and
listing, as well as each year thereafter.68 (For devices subject to premarket review, this occurs
after clearance or approval is received.) In required MDUFA quarterly reports, FDA publishes
data on current active registrations by type of facility (e.g., manufacturer, initial importer) and
specifies whether these facilities are domestic or foreign.69
Submission of Supply Chain Information
Upon Importation
All products offered for importation into the United States must be declared to U.S. Customs and
Border Protection (CBP), and product entry information must be filed in the Automated
Commercial Environment (ACE) system.70 CBP refers all FDA-regulated products to FDA for

62 21 C.F.R. §807.92(a)(1).
63 21 C.F.R. §807.81(a)(3).
64 21 C.F.R. §814.39.
65 21 C.F.R. §814.39(a)(3).
66 21 C.F.R. §807.81(a)(3)(i).
67 21 C.F.R. §814.82. See also FDA, Guidance for Industry and Food and Drug Administration Staff: Annual Reports
for Approved Premarket Approval Applications (PMA), p. 6, December 16, 2019, https://www.fda.gov/media/73391/
download.
68 FFDCA §738(a)(3); 21 U.S.C. §379j(a)(3).
69 See, for example, FDA, “Quarterly Update on Medical Device Performance Goals, MDUFA IV CDRH Performance
Data,” p. 303, February 21, 2020, https://www.fda.gov/media/135471/download.
70 FDA, “Import Basics,” https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/import-
basics. See also “Automated Commercial Environment/International Trade Data System (ACE/ITDS),”
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review and determination of admissibility. Imported FDA-regulated products may be refused
admission into the United States for a variety of reasons, including if FDA determines that a
product appears to be adulterated or misbranded.71 FDA may destroy certain drugs that have been
refused admission into the United States.72
To facilitate admissibility determinations, the agency has promulgated regulations that require
importers to submit certain data elements in ACE for all imported FDA-regulated products and
additional information for specific product types (e.g., drugs, devices). FDA-regulated products
submitted to ACE must include the following general data elements:73
 FDA country of production. The country where the article was last
manufactured, processed, or grown. FDA regulations clarify that “the FDA
Country of Production for an article that has undergone any manufacturing or
processing is the country where that activity occurred provided that the
manufacturing or processing had more than a minor, negligible, or insignificant
effect on the article.” For example, if an API is made in one country but exported
into another to be encapsulated into the final dosage form, the country where the
drug was encapsulated would be the FDA country of production. This data
element is different from CBP’s use of the substantial transformation test to
determine country of origin.74
 FDA product code. An alphanumeric code used to describe a specific product.75
 Full intended use code. A code used to denote the intended use of the product
(e.g., whether the product is an API intended for investigational use, personal
use, or commercial use).
 Importer of record contact information. The telephone and email address of
the importer.
In general, medical products made in foreign countries and imported into the United States for
commercial distribution must comply with the same FFDCA requirements as domestically
manufactured medical products, including registration, listing, and premarket authorization.76 As
such, for drugs and biologics regulated by FDA’s Center for Drug Evaluation and Research
(CDER), the filer must also submit in ACE the registration and listing information for the drug or
biologic, as well as the approved application number or investigational new drug application
number (in the case of a drug being imported for clinical testing in humans).77 For a device

https://www.fda.gov/industry/import-systems/automated-commercial-environmentinternational-trade-data-system-
aceitds.
71 FFDCA §801(a); 21 U.S.C. §381(a).
72 FFDCA §801(a); 21 U.S.C. §381(a). See also FDA, “Administrative Destruction of Certain Drugs Refused
Admission to the United States,” 80 Federal Register 55237, September 15, 2015.
73 21 C.F.R. §1.72.
74 FDA, “Submission of Food and Drug Administration Import Data in the Automated Commercial Environment,” 81
Federal Register 85854, November 29, 2016. CBP’s substantial transformation test contends that “substantial
transformation occurs in the country where the article acquired the name, character, or intended use that matches the
article identified in the entry.”
75 FDA, “Product Codes and Product Code Builder,” https://www.fda.gov/industry/import-program-resources/product-
codes-and-product-code-builder.
76 Requirements governing importation of prescription drugs are discussed in more detail in CRS In Focus IF11056,
Prescription Drug Importation.
77 21 C.F.R. §1.74.
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regulated by the Center for Devices and Radiological Health (CDRH), the ACE filing information
must include the registration and listing information; the investigational device exemption
number or premarket number, if applicable; and “an affirmation identifying that the article being
imported or offered for import is a component that requires further processing or inclusion into a
finished medical device,” if applicable.78 In addition, the regulations require an “affirmation of
compliance” for specific devices or device components (e.g., lead wires/patient cables). For
biologics and devices (e.g., certain in vitro diagnostics) regulated by the Center for Biologics
Evaluation and Research (CBER), the filer must submit in ACE the product application number,
the registration and listing information, the product name, and, if applicable, the tracking number
for the BLA and other device-related information.79
In certain cases, medical products or their components may be imported into the United States for
further processing and subsequent exportation. In such cases, the importer must submit to FDA a
statement providing that such article is intended to be further processed and exported; indicating
the manufacturer of the article and each other entity that had possession of the article from the
manufacturer to the importer of the article; and providing a certificate of analysis to identify such
article unless it is a device or blood product.80 Provided these conditions are met, a foreign
establishment that imports drugs or drug components for further processing into the United States
for exportation is exempt from registration and listing requirements.81
Medical products also may be manufactured in their entirety in the United States solely for export
purposes. Foreign companies or governments may require an exporting company to provide an
export certificate containing information about a product’s regulatory or marketing status. FDA is
required to issue export certificates, upon request, for (1) drugs and devices manufactured in the
United States that meet applicable FFDCA requirements and may be lawfully marketed in the
United States, or (2) for drugs and devices that may not lawfully be marketed in the United States
(e.g., lack marketing authorization) but may be lawfully exported.82
Collection of Supply Chain Information as Part of
Facility Inspections
FDA obtains information about drug and device manufacturing through establishment
inspections, which are conducted throughout the lifecycle of a drug or device (i.e., premarket and
postmarket). The agency conducts inspections to verify that FDA-regulated products are
manufactured in compliance with current good manufacturing practices (CGMPs) and other
FFDCA and regulatory requirements. Other federal agencies, particularly the Government
Accountability Office (GAO), have investigated how FDA inspects drug manufacturers. To avoid
duplication of work with GAO, in this report facility inspections are discussed only in the context
of the supply chain related-information that FDA obtains from such inspections. (See Appendix

78 21 C.F.R. §1.76.
79 21 C.F.R. §1.78.
80 FFDCA §801(d)(3) [21 U.S.C. §381(d)(3)].
81 21 C.F.R. §207.13. FDA, “Requirements for Foreign and Domestic Establishment Registration and Listing for
Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs,” 81
Federal Register 60184, August 31, 2016.
82 FFDCA §801(e)(4) [21 U.S.C. §381(e)(4)]. FDA, CPG Sec. 110.100 Certification for Exports, April 2000,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-110100-certification-exports.
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C for further resources pertaining to facility inspections—including foreign facility inspections—
and other medical supply chain-related resources.)
Current Good Manufacturing Practices (CGMPs)
As noted above, FDA-regulated products, including medical products, are subject to CGMPs.
Manufacturers of drugs—finished drugs and APIs—must comply with CGMPs to ensure that the
products are safe and meet their purported or represented purity, strength, identity, and quality
characteristics. For drugs, CGMPs include “the implementation of oversight and controls over the
manufacture of drugs to ensure quality, including managing the risk of and establishing the safety
of raw materials, materials used in the manufacturing of drugs, and finished drug products.”83
FDA has promulgated CGMP regulations for the manufacture of finished drugs,84 which provide
minimum requirements for the methods, facilities, and controls used in manufacturing. FDA has
not issued CGMP regulations for API manufacturing. However, the agency recognizes that the
CGMP regulations for finished drugs “are valid and applicable in concept to [API]
manufacturing.”85 Device manufacturers must also comply with CGMPs to ensure that their
products are safe, effective, and otherwise in compliance with the FFDCA.86 FDA has
promulgated CGMP regulations for devices through the quality system (QS) regulation.87
Generally, records required to be kept as part of drug CGMPs or in compliance with the device
QS regulation do not need to be proactively reported by manufacturers; instead, they are subject
to FDA review during facility inspections.88 For drugs, manufacturers must maintain distribution
records containing the name and strength of the product and description of the dosage form, name
and address of the consignee, date and quantity shipped, and lot or control number of the drug
product.89 In addition, certain distribution records are required for all finished devices, including
accessories to any device that are suitable for use or capable of functioning, regardless of whether
they are packaged, labeled, or sterilized.90 Specifically, each manufacturer is required to maintain
distribution records that include the name and address of the initial consignee, as well as the
identification and the quantity of devices shipped.91 In addition, manufacturers are required to
maintain a device history file (DHF), which must include the quantity of devices manufactured
and distributed, among other things.92
Types of Facility Inspections
FDA generally conducts three types of inspections for drugs and devices:

83 FFDCA §501 [21 U.S.C. §351].
84 21 C.F.R. Parts 210 and 211.
85 FDA, Compliance Program 7356.002F, Active Pharmaceutical Ingredient (API) Process Inspection, p. 4,
https://www.fda.gov/media/75201/download.
86 FFDCA §520(f); 21 U.S.C. §360j(f).
87 21 C.F.R. Part 820.
88 21 C.F.R. §§211.180 and 820.180.
89 21 C.F.R. §211.196.
90 21 C.F.R. §820.3(l).
91 21 C.F.R. §820.160(b).
92 21 C.F.R. §820.184.
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 Preapproval inspections are conducted as part of the drug review process before
approving an NDA, ANDA, or BLA, and as part of the device review process for
devices subject to a PMA or PMA supplement.
 For-cause inspections are conducted in response to specific issues, for example,
consumer complaints or as a follow-up to previous FDA regulatory action.
 Surveillance inspections assess manufacturer compliance with CGMPs once a
drug or device is on the market.
Pursuant to changes made by the FDA Safety Innovation Act of 2012 (FDASIA, P.L. 112-144),
FDA must inspect both domestic and foreign drug and device establishments on a risk-based
schedule.93 Prior to FDASIA, FDA was required to inspect domestic establishments every two
years, with no comparable requirement for foreign establishments. FDASIA required a risk-based
schedule for all establishments, regardless of location. The law also directed FDA to institute a
risk-based inspection schedule that considers the safety risks of an establishment, for example, its
compliance history and the inherent risk of the drug or device.94 According to FDA, this statutory
change was consistent with the CDER Site Selection Model (SSM) used by FDA since 2005 and
explicitly allowed FDA to place less emphasis on a set frequency of inspection.95 CDER runs its
SSM twice a year to determine which manufacturing establishments should be prioritized for
surveillance inspections. CDRH lists its priorities for surveillance inspections in its compliance
program guidance manual. The manual provides a list of firms that are considered higher risk
(e.g., those that manufacture class III [high risk] devices that have never been inspected) and
should be prioritized. Manufacturers of class I (low risk) devices, per the handbook, should
receive lowest inspectional priority unless certain circumstances warrant an inspection sooner
(e.g., health hazard is apparent).96
FDA may enter into agreements with foreign governments to recognize surveillance inspections
conducted by foreign regulatory authorities of registered foreign drug and device manufacturing
establishments. For example, FDA has a mutual recognition agreement (MRA) with the European
Union (EU) and recognizes the surveillance inspection conducted by certain regulatory
authorities in the EU.97
Records from Facility Inspections
At the conclusion of an inspection, the FDA inspector issues a Form 483 to the owner or agent in
charge of the establishment. This form lists any conditions observed during the inspection that
may render an FDA-regulated product to be adulterated and in violation of the FFDCA.98 Form

93 FFDCA §510(h); 21 U.S.C. §360(h).
94 FFDCA §510(h)(4). FDA is also required to consider the record, history, and nature of recalls linked to the
establishment; “the inspection frequency and history of the establishment, including whether the establishment has
been inspected pursuant to section 704 within the last 4 years; whether the establishment has been inspected by a
foreign government or an agency of a foreign government recognized under section 809; and any other criteria deemed
necessary and appropriate by the Secretary for purposes of allocating inspection resources.”
95 FDA, Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality, MAPP 5014.1,
Understanding CDER’s Risk-Based Site Selection Model, https://www.fda.gov/media/116004/download.
96 FDA, Compliance Program Guidance Material, Program 7382.845, Inspection of Medical Device Manufacturers,
https://www.fda.gov/media/80195/download.
97 FDA, “Mutual Recognition Agreement (MRA),” https://www.fda.gov/international-programs/international-
arrangements/mutual-recognition-agreement-mra; FDA, “List of Devices for MRA Review,”
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/mra.cfm?panel=AN.
98 FFDCA §704 (b)(1) [21 U.S.C. §374(b)(1)]. FDA, “FDA Form 483 Frequently Asked Questions,”
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483 is not an all-inclusive listing of potential FFDCA violations, nor does it constitute a final
agency determination of whether an establishment is in violation of the FFDCA. After completing
a facility inspection, the inspector prepares an Establishment Inspection Report (EIR), which
documents inspection findings and provides a preliminary recommendation regarding whether
enforcement action should be taken. The recommendation is made using one of three
classifications: no action indicated (NAI), voluntary action indicated (VAI), or official action
indicated (OAI).99 For surveillance inspections, NAI and VAI recommendations are reviewed
within the Office of Regulatory Affairs (ORA). OAI recommendations are sent to the appropriate
FDA Center (e.g., CDER for drugs, CDRH for devices), which reviews the recommendation and
determines whether regulatory action is needed. Regarding for-cause inspections, the appropriate
FDA Center is to review the inspection reports and initial classification recommendations,
regardless of whether it was classified as OAI.100
FDA maintains a public Inspection Classification Database, which lists inspections conducted by
the agency and its assessments of regulated establishments’ compliance with FDA law and
regulation. The database does not include all inspections conducted by FDA. For example,
preapproval inspections are excluded from the database, and the database does not disclose which
drugs or devices are made in a specific facility.101 However, the database does allow the public to
see how FDA classified the inspection of a specific manufacturing establishment (e.g., OAI, NAI)
and where that establishment is located (i.e., city, state, and country). On occasion, FDA makes
available redacted inspection records (e.g., a Form 483 or an EIR) requested pursuant to a
Freedom of Information Act (FOIA) request.
For drugs, FDA can require manufacturers to submit records or other information subject to
inspection in advance prior to or in lieu of an inspection.102 For example, FDA appears to have
relied upon this authority during the COVID-19 pandemic, when the agency’s ability to inspect
drug establishments was limited.103 Device manufacturers are not subject to this requirement, but
they may choose to comply if the agency makes such a request.
Other Supply Chain Reporting Requirements
To enhance FDA’s capacity to assess the medical product supply chain and manufacturing,
Congress has created additional legislative requirements for reporting drug and device
manufacturing interruptions and for tracking drugs as they are distributed to consumers.104

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-
483-frequently-asked-questions.
99 GAO, “Preliminary Findings Indicate Persistent Challenges with FDA Foreign Inspections,” GAO-20-262T,
December 2019, p. 9, https://www.gao.gov/assets/710/703078.pdf.
100 GAO, “Drug Safety: COVID-19 Complicates Already Challenged FDA Foreign Inspection Program,” June 2, 2020,
p. 8, https://www.gao.gov/assets/710/707345.pdf.
101 FDA, “Inspections Database Frequently Asked Questions,” https://www.fda.gov/inspections-compliance-
enforcement-and-criminal-investigations/inspection-references/inspections-database-frequently-asked-questions.
102 FFDCA §704(a)(4) [21 U.S.C. §374(a)(4)].
103 FDA, Guidance for Industry: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During
COVID-19 Public Health Emergency Questions and Answers, August 2020, https://www.fda.gov/media/141312/
download.
104 This is not intended to be an exhaustive list of all reporting requirements in the FFDCA. For example, the FFDCA
and FDA regulations mandate reporting of serious adverse events associated with use of a drug or device and while
adverse event reports may trigger FDA facility inspections or regulatory action, these reporting requirements are
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Manufacturing Interruptions, Discontinuances, and Shortages
To help prevent and mitigate shortages, manufacturers of certain drugs and devices must notify
FDA of any interruptions or discontinuances in their manufacturing. FDA is required to take
certain mitigating actions in response to such notification. For example, FDA must prioritize and
expedite facility inspections and review of certain regulatory submissions. When FDA receives
notifications from drug and device manufacturers reporting an interruption in manufacturing, the
agency generally does not make this information public on its website. However, FDA is required
to distribute this information to appropriate organizations (e.g., physicians, supply chain partners)
unless such a disclosure would adversely affect the public’s health.105 If a manufacturer fails to
submit the required information, FDA must submit a letter to the manufacturer documenting this
failure. The manufacturer is required to respond with reasons for noncompliance, as well as with
information on interruptions or discontinuances as originally required, within 30 days. FDA
makes such information public within 45 days of receipt but is not permitted to disclose any
information considered confidential or a trade secret.106
Notably, drug manufacturers are required to report such interruptions or discontinuances at any
time, while device manufacturers are subject to this requirement only in the context of a public
health emergency. The reporting requirements specific to drugs and devices are described in more
detail below.
Drugs
Congress first required certain drug manufacturers to report shortage-related information to FDA
in 1997, with enactment of the Food and Drug Administration Modernization Act of 1997
(FDAMA; P.L. 105-115). Subsequent legislation—FDASIA (P.L. 112-144) and the CARES Act
(P.L. 116-136)—expanded these requirements.107 As amended, the FFDCA requires a
manufacturer of a drug that is life-supporting, life-sustaining, or intended to prevent or treat a
debilitating disease or condition to notify FDA of any permanent discontinuance or interruption in
the manufacture of the drug (or API of such drug) that is likely to disrupt its U.S. supply.108 The
notification must include the reasons for the interruption or discontinuance, information about the
source of the API and alternative sources, and whether any associated device used in the
preparation or administration of the drug has contributed to the shortage, among other
information. In addition, as mandated by the CARES Act amendments to the FFDCA, a
manufacturer of a drug, API, or associated medical device subject to these notification
requirements must develop, maintain, and implement a redundancy risk management plan, as
appropriate, for each establishment that manufactures such a drug or its API.109 The risk

generally outside the scope of this report.
105 FFDCA §506C(c) [21 U.S.C. §356c(c)]; FFDCA §506J(c); 21 U.S.C. §356j(c).
106 FFDCA §506C(d) and (f) [21 U.S.C. §356c(d) and (f)]; FFDCA §506J(e) [21 U.S.C. §356j(e)].
107 Section 131 of FDAMA established FFDCA Section 506C requiring that a sole-source manufacturer of an approved
drug that is life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or
condition notify FDA of any discontinuance in the manufacture of the drug. Section 1001(a) of FDASIA amended
FFDCA Section 506C, among other things, to expand these reporting requirements beyond sole-source manufacturers
and to require notification of any interruption in manufacturing, not just discontinuance. Section 3112 of the CARES
Act further amended FFDCA Section 506C to require a manufacturer to notify FDA of any permanent discontinuance
or interruption in the manufacture of an API—not just the finished drug—that is likely to lead to a meaningful
disruption in the supply of the API of such drug.
108 FFDCA §506C(a); 21 U.S.C. §356c(a).
109 FFDCA §506C(j); 21 U.S.C. §356c(j).
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management plan, which is subject to inspection and copying by FDA, should identify and
evaluate risks to the supply of the drug, as applicable, for each facility in which the drug or API is
manufactured.
Devices
As mandated by the CARES Act (P.L. 116-136), device manufacturers are required to report to
FDA during or prior to a public health emergency any permanent discontinuance of production,
or interruption in production, likely to lead to a significant disruption in the supply of a device,
including the reasons for the discontinuance or interruption.110 This information must be reported
to FDA at least six months prior to occurrence, or as soon as is practical.111
FDA has issued guidance to help affected manufacturers implement this provision in the context
of COVID-19.112 The guidance, in addition to outlining the requirements specified in statute,
specifies additional voluntary information that would help the agency identify shortages. Such
information includes, among other things, how COVID-19 has affected the ability to manufacture
or distribute a device, and how reliance on a critical supplier affected by COVID-19 may have an
adverse impact on the ability to manufacture a device.113
Shortage Lists
To make the public aware of supply chain disruptions, FDA is required, by law, to maintain
public, up-to-date lists of drugs and devices that are in short supply.114 FDA publishes lists of
drugs and devices that the agency determines are in shortage based on the information it receives
from various entities. Such lists must include the name of the drug in shortage, the name of the
manufacturer, and the estimated duration of and reason for the shortage, as determined by FDA.
The agency maintains this list in the form of a searchable database for drugs.115 FDA publishes a
separate list of CBER-regulated biologics that are in shortage.116
Similarly, FDA is required to establish and maintain a device shortage list. This list includes,
among other things, the category or name of the device in shortage and, as determined by FDA,
the reason(s) for the shortage (e.g., demand increase for the device) and the expected duration of
the shortage, in the context of a public health emergency. For example, FDA has recently
published a list of devices that are in shortage during the COVID-19 public health emergency.117

110 FFDCA §506J(a); 21 U.S.C. §356j(a).
111 FFDCA §506J(b); 21 U.S.C. §356j(b). Per FDA guidance, FDA interprets “as soon as is practicable” to mean no
later than seven calendar days after the discontinuance or interruption in manufacturing occurs. FDA, Guidance for
Industry and Food and Drug Administration Staff: Notifying CDRH of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, p.
5, June 2020, https://www.fda.gov/media/137712/download, (hereinafter FDA, Guidance: Notifying CDRH of a
Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During
the COVID-19 Public Health Emergency).
112 FDA, Guidance: Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency.
113 FDA, Guidance: Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, pp. 11-12.
114 FFDCA §506E [21 U.S.C. §356e]; FFDCA §506J(g) [21 U.S.C. §356j(e)].
115 FDA, “FDA Drug Shortages,” https://www.accessdata.fda.gov/scripts/drugshortages/.
116 FDA, “CBER-Regulated Products: Current Shortages,” https://www.fda.gov/vaccines-blood-biologics/safety-
availability-biologics/cber-regulated-products-current-shortages.
117 FDA, “Medical Device Shortages During the COVID-19 Public Health Emergency,” https://www.fda.gov/medical-
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The FFDCA requires that such drug and device shortage information be made public unless it is
considered confidential, a trade secret, or determined by FDA to be harmful to the public (e.g.,
increases the possibility of hoarding). These drug and device shortage lists do not disclose the
location of the manufacturers.
Drug Supply Chain and Security
The Drug Supply Chain Security Act (DSCSA), enacted as Title II of the Drug Quality and
Security Act (DQSA, P.L. 113-54), expanded FDA’s authority to monitor the drug supply chain
and prevent suspect or illegitimate drugs (e.g., counterfeit or diverted drugs) from getting to
consumers.118 Pursuant to changes made by the DSCSA, certain trading partners (i.e.,
manufacturers, repackagers, wholesale distributors, and dispensers) are required to maintain and
exchange certain transaction information (e.g., drug product name, NDC, shipment date) with
respect to a drug.119 Manufacturers and repackagers are required to affix a “product identifier” on
packages for certain prescription drugs. If a trading partner determines itself to be in possession
of a drug that is suspect or illegitimate, the trading partner must take certain steps to prevent the
drug from being distributed (e.g., quarantine or dispose of the product, notify FDA and other
trading partners). The law requires that not later than 10 years after enactment, an electronic,
interoperable system be used to identify and trace at the package level certain prescription drugs
as they are distributed in the United States.120 The DSCSA is required to be implemented over
time. As such, certain requirements have taken effect (e.g., establishment of product verification
systems by trading partners), while others (e.g., establishment of an electronic interoperable
system) have not.121 Certain DSCSA requirements may be waived if the HHS Secretary declares a
public health emergency under PHSA Section 319. There are no parallel requirements for devices.
Select Issues for Congress
Certain concerns about the U.S. medical product supply chain existed prior to the emergence of
COVID-19. In the context of the ongoing pandemic, however, addressing those concerns has
become more urgent. Of particular importance to many are gaining a better understanding of
certain aspects of the medical product supply chain, U.S. reliance on foreign sources of medical
products, and the federal government’s ability to oversee the supply chain and mitigate future
disruptions. In particular, some stakeholders and Members of Congress have raised concerns
about the lack of information sharing and publicly available data regarding location and quantity
of medical product manufacturing. However, the publication of certain medical product-related
information and data may be constrained when regarded as a trade secret or confidential
commercial information. This section discusses three overarching issues in the context of FDA’s
existing authority:
1. Gaps or loopholes in reporting requirements to FDA limit the agency’s ability to
oversee the medical product supply chain.

devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-
emergency.
118 The DQSA, enacted on November 27, 2013, amended FFDCA Chapter V to add a new Subchapter H
“Pharmaceutical Distribution Supply Chain.”
119 FFDCA §582(a)-(e); 21 U.S.C. §360eee-1(a)-(e).
120 FFDCA §582(g); 21 U.S.C. §360eee-1(g).
121 FDA, “Drug Supply Chain Security Act (DSCSA),” https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-
supply-chain-security-act-dscsa.
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2. Limitations in currently available supply chain data make it challenging to
determine how reliant the United States is on foreign medical product
manufacturers.
3. A lack of transparency in the medical product supply chain may contribute to
product shortages and pose a risk to national security.
These issues are discussed in further detail below, along with potential considerations for
policymakers.
Gaps in Reporting Requirements and Limits to FDA Oversight
CDER maintains a catalog of all
Exceptions During Emergencies
establishments manufacturing drugs for the
Under emergency circumstances such as the COVID-
United States, whether they are doing so
19 pandemic, FDA may waive some of the
through an approved application or by
requirements discussed in this report. In particular, an
emergency use authorization (EUA) allowing for the
registering and listing to supply drugs for the
distribution and use of an unapproved medical product
U.S market. The catalog includes
enables FDA to waive CGMPs and exempts EUA
establishments making API and finished
products from the registration and listing requirements.
drugs. However, the data available to CDER
FDA has issued several EUAs during the COVID-19
are limited. For example, CDER has limited
pandemic. While the purpose of these EUAs was to
increase availability of and access to PPE, ventilators,
information about establishments that provide
drugs, and other medical products, waiving or
API for drug products that do not need an
modifying regulatory requirements is not without risk
approved application from FDA to be
and may affect the safety, effectiveness, and quality of
marketed (e.g., OTC monograph drugs).
the medical product. For example, in April 2020, FDA
According to testimony from CDER Director
issued an EUA allowing certain non-FDA-cleared
respirators to be imported from China. However, FDA
Janet Woodcock, “API suppliers for such
subsequently amended the EUA to exclude certain
products may not register their facility with
previously authorized respirators because they failed to
FDA if they are sending material to a drug
demonstrate adequate filtration performance in later
product manufacturer outside the United
testing.122
States to make the FDF, which is then sold in
the United States.”123 As an example, in the case of an establishment in China manufacturing an
API that is exported to Germany to be made into a finished OTC monograph drug that is then
exported to the United States, the establishment in China may not be registered with FDA, since it
is not importing directly to the United States. The facility in Germany would be required to
register with FDA and provide, as part of the listing information, the name and UFI of every other
establishment that manufactures the drug (e.g., the facility in China) and the type of operation
performed at each such establishment.124 However, the API facility in China may not be captured
by the listing requirements or annual manufacturing quantity reporting requirements established
by the CARES Act. As mentioned, while FDA may also obtain information about a foreign API
manufacturer through the NDA process, the agency has limited information about upstream

122 FDA, “Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection -
Letter to Health Care Providers,” June 7, 2020, https://www.fda.gov/medical-devices/letters-health-care-providers/
certain-filteringfacepiece- respirators-china-may-not-provide-adequate-respiratory-protection-letter.
123 FDA, Testimony of Dr. Janet Woodcock, “Safeguarding Pharmaceutical Supply Chains in a Global Economy.”
124 21 C.F.R. §207.49(a)(12)(ii). See also GAO-10-961, FDA Has Conducted More Foreign Inspections and Begun to
Improve Its Information on Foreign Establishments, but More Progress Is Needed, September 2010, p. 10,
https://www.gao.gov/new.items/d10961.pdf.
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establishments involved in the manufacture of drug products that are not subject to an NDA or
ANDA (e.g., compounded drugs or OTC monograph drugs).125
Given the gaps in existing requirements, legislation has been introduced that would explicitly
require a foreign-based establishment to register with FDA, list the drugs manufactured for
commercial distribution, and report quarterly on quantity manufactured, regardless of whether the
finished drug or API undergoes further manufacture or processing at a separate establishment
prior to being imported or offered for import into the United States.126
Limitations also have been identified in reporting requirements related to drug and device
shortages. As mentioned, the CARES Act established new requirements for devices and expanded
existing reporting requirements for drugs to include interruptions in manufacturing of API (see
the “Drugs” section of this report). However, manufacturers are not required to report to FDA if a
shortage is due to other factors, for example, an increase in product demand or an export
restriction imposed by the country in which the product is manufactured. The CARES Act
provision regarding devices is applicable only in the context of a public health emergency.
Although reported shortages of personal protective equipment (PPE) and ventilators have
occurred during the COVID-19 public health emergency, device shortages can occur under other
circumstances. For example, prior to COVID-19, concerns about medical device shortages arose
due to the closure of ethylene oxide sterilization facilities that were not in compliance with U.S.
Environmental Protection Agency (EPA) standards.127 When the facilities closed, FDA relied on
the manufacturers’ voluntary reports on the device shortages. Legislation has been introduced that
would expand reporting of device manufacturing interruptions, as well as device shortage lists,
beyond the context of public health emergencies.128 In addition, some legislation that has been
introduced would allow for importation of unapproved devices in the case of a device shortage,129
an authority that currently exists for drugs, but not for devices.130
The addition of registration and reporting requirements raises an inherent tension between
providing FDA with needed, timely information and placing additional, potentially burdensome
requirements on manufacturers. If such registration and reporting requirements are added, it is
unclear whether they will give FDA the information needed in real-time to proactively mitigate
disruptions in the medical product supply chain. Further, some companies do not properly comply
with the registration and listing requirements, which can hinder the agency’s ability to access
accurate, up-to-date information.131 To address this issue, as described earlier in this report, there
are certain reporting requirements for discontinuances or interruptions in manufacturing. Some
legislation that has been introduced would require quarterly reporting of certain information, such

125 FDA, Testimony of Dr. Janet Woodcock, “Safeguarding Pharmaceutical Supply Chains in a Global Economy.” See
also GAO, DRUG SAFETY, Better Data Management and More Inspections Are Needed to Strengthen FDA’s Foreign
Drug Inspection Program, GAO-08-970, September 2008, p. 18, https://www.gao.gov/assets/290/281366.pdf.
126 H.R. 6800 (116th Congress) §30515 and S. 3781 (116th Congress).
127 FDA, “Statement on concerns with medical device availability due to certain sterilization facility closures,” October
25, 2019, https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-
certain-sterilization-facility-closures.
128 H.R. 6049 (116th Congress); H.R. 6062 (116th Congress); S. 3468 (116th Congress); S. 3343 (116th Congress).
129 H.R. 6062 (116th Congress).
130 FFDCA §801(d)(1)(B) [21 U.S.C. §381(d)(1)(B)]
131 See, for example, FDA, “Warning Letter: NuCare Pharmaceuticals Inc,” September 26, 2019, https://www.fda.gov/
inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nucare-pharmaceuticals-inc-588096-
09262019.
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as the amount of drug or device manufactured.132 However, it is unclear whether increasing the
frequency of reporting information already submitted to the agency will be useful.
Limitations of Currently Available Data
The COVID-19 pandemic has underscored concerns regarding U.S. reliance on foreign countries
for medical products, particularly drugs and APIs. A frequently cited figure is that 80% of APIs
are made overseas, although questions remain about the origin of this figure.133 Regardless, the
extent to which the United States relies on other countries for medical products is not entirely
known due to limitations in data collected by FDA and trade data. Limitations in FDA data are
described below; trade data are discussed in CRS Report R46304, COVID-19: China Medical
Supply Chains and Broader Trade Issues.
API
Historically, FDA has been able to describe, in general, where drug manufacturing sites are
located (e.g., what percentage of API facilities manufacturing drugs for the U.S. market are
located outside the United States or in a specific country), but not the volume of API
manufactured.134 According to Dr. Woodcock’s 2019 congressional testimony,
Although CDER can describe the locations of API manufacturing facilities, we cannot
determine with any precision the volume of API that China is actually producing, or the
volume of APIs manufactured in China that is entering the U.S. market, either directly or
indirectly by incorporation into finished dosages manufactured in China or other parts of
the world.135
This limitation exists because although drug manufacturers are required to register their
establishments with FDA and list the drugs they produce for commercial distribution, registrants
are not required to report to FDA on the volume they are manufacturing. In addition, APIs made
in registered establishments may be used to make finished drugs for both the U.S. market and
other countries, and some APIs sold in the United States are subsequently formulated into
finished drugs that are then exported.136 As such, FDA generally has been able to determine which
facilities are manufacturing a drug but unable to determine the quantity manufactured at each
facility, particularly in the case of API. Provisions in the CARES Act attempt to remedy this gap

132 H.R. 6800 (116th Congress) §30515(c); S. 3781 (116th Congress).
133 For example, the 2019 annual report to Congress from the U.S.-China Economic and Security Review Commission
states that the United States sources 80% of its APIs from foreign countries and has identified China as the world’s
largest producer of APIs. A 2011 FDA report, Pathway to Global Product Safety and Quality, states that 80% of APIs
come from overseas and cites the 1998 GAO report Improvements Needed in the Foreign Drug Inspection Program as
the source of this number. The 1998 GAO report, in turn, states, “According to FDA, as much as 80 percent of the bulk
pharmaceutical chemicals used by U.S. manufacturers to produce prescription drugs is imported.”
134 FDA, Testimony of Judith McMeekin, Associate Commissioner for Regulatory Affairs, Mark Abdoo, Associate
Commissioner for Global Policy and Strategy, and Douglas Throckmorton, Deputy Director for Regulatory
Programs—Center for Drug Evaluation and Research, “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug
Manufacturing Inspection Process,” June 2, 2020, https://www.fda.gov/news-events/congressional-testimony/covid-19-
and-beyond-oversight-fdas-foreign-drug-manufacturing-inspection-process-06022020, (hereinafter, FDA, Testimony of
Judith McMeekin, Mark Abdoo, and Douglas Throckmorton, “CDER COVID-19 and Beyond: Oversight of the FDA’s
Foreign Drug Manufacturing Inspection Process.”).
135 FDA, Testimony of Dr. Janet Woodcock, “Safeguarding Pharmaceutical Supply Chains in a Global Economy.”
136 FDA, Testimony of Dr. Janet Woodcock, “Safeguarding Pharmaceutical Supply Chains in a Global Economy.”
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by establishing annual reporting requirements for manufacturing quantity of drugs,137 and
legislation has been introduced to further expand this reporting requirement.138
FDA reports that between 70%-90% of API facilities are located outside of the United States, and
that these numbers vary over time. For example,
 According to June 2020 congressional testimony from FDA officials, “As of May
2020, 26 percent of facilities manufacturing APIs and 46 percent of the facilities
producing finished dosage forms (FDFs) of human drugs for the U.S. market
were located in the U.S.”139
 According to October 2019 congressional testimony from FDA CDER Director
Janet Woodcock, “As of August 2019, only 28 percent of the manufacturing
facilities making APIs to supply the U.S. market were in our country. By
contrast, the remaining 72 percent of the API manufacturers supplying the U.S.
market were overseas, and 13 percent are in China.” 140
 According to FDA’s October 2019 drug shortages report, “In 2018, 88 percent of
the manufacturing sites making APIs and 63 percent of sites making finished
dosage forms (FDFs) were located overseas (FDA Internal Memorandum 2019;
Van Den Bos 2009).”141
 According to FDA’s October 2019 At a Glance fact sheet, “about 80 percent of
active pharmaceutical ingredients manufacturers are located outside of the
U.S.”142
As FDA has noted, information in the CDER site catalog is continually updated, and the numbers
regarding facility location generally represent “a snapshot at a point in time.”143
Other Medical Product Data
FDA reports some data on foreign-sourced products in terms of import lines. FDA uses the term
import line to denote each distinct regulated product within a shipment through CBP.144 An import
line does not indicate volume or quantity imported, nor does it necessarily comport with other
figures provided by FDA. For example, according to the agency’s import summary dashboard, in
FY2019, 45,220,000 total lines of FDA-regulated products were imported, of which 21,487,882
were devices (48%) and 1,011,202 (2%) were drugs and biologics.145 However, according to the

137 FFDCA §510(j)(3) [21 U.S.C. §360(j)(3)], as amended by §3112(e) of the CARES Act.
138 See, for example, H.R. 6800 (116th Congress) §30515.
139 FDA, Testimony of Judith McMeekin, Mark Abdoo, and Douglas Throckmorton, “CDER COVID-19 and Beyond:
Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.”
140 FDA, Testimony of Dr. Janet Woodcock, “Safeguarding Pharmaceutical Supply Chains in a Global Economy.”
141 FDA, “Drug Shortages: Root Causes and Potential Solutions,” initial report was published in October 2019 and
subsequently updated in March 2020, p. 27, https://www.fda.gov/media/131130/download.
142 FDA, “Fact Sheet: FDA at a Glance,” October 18, 2019, https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-
glance, (hereinafter, FDA, “Fact Sheet: FDA at a Glance.”).
143 FDA, Testimony of Dr. Janet Woodcock, “Safeguarding Pharmaceutical Supply Chains in a Global Economy.”
144 According to Chapter 6 of the FDA Investigations Operations Manual, p. 33, https://www.fda.gov/media/75256/
download: “A line is each portion of an entry which is listed as a separate item on an entry document. An importer may
identify goods in an entry in as many portions as he chooses, except each item in the entry having a different tariff
description and rate must be listed separately.”
145 FDA, “Imports Summary,” https://datadashboard.fda.gov/ora/cd/impsummary.htm. The remaining 50% of FDA-
regulated product import lines include cosmetics, human foods, animal feed, houseware- and food-related products,
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agency’s October 2019 fact sheet, about 35% of devices used in the United States are imports,
and 70% of biologics sales are imports.146 Given that FDA generally does not make public how
these metrics are calculated or what data source they are based on, precisely determining U.S.
reliance on foreign sources of medical supplies is difficult. Further, limited data on volume
manufactured makes it difficult to ascertain how much of a medical product or its components is
manufactured in a specific country.
In October 2019, FDA reported that 52% of registered facilities manufacturing devices are
located in the United States.147 However, as noted above, FDA data do not provide a detailed
breakdown of where specific devices or device components are made and do not quantify the
amount or proportion of devices made in a specific country. Other resources provide some insight
regarding where select device components are made. For example, proceedings from a 2018
NASEM meeting note that “90 percent of the latex for sterile gloves is produced in Malaysia ...
and a significant portion of surgical hand instruments are manufactured in Pakistan.”148 However,
the report generated from those proceedings did not specify how these data were determined, and
did not provide more comprehensive data across the range of devices on the market. Different
medical device industry reports by country149 and trade data may be used to determine where
some devices or device components are made, but these data have limitations as well.150
Lack of Transparency in the Supply Chain
The location or locations in which a finished drug or its ingredients are manufactured are not
required to be disclosed on the drug’s label. This also applies to devices. Instead, a drug or device
in finished package form must contain the name and place of business of the manufacturer,
packer, or distributor.151 As mentioned above, product labeling and public FDA databases do not
disclose the country of origin or the location of drug and device manufacturers. Health care
providers and health care facilities may be particularly affected by this omission. For example,
hospitals often make purchasing decisions without any information about drug manufacturing
location or data on manufacturing quality.152 A hospital may not know that a critical drug is made
in a hurricane-prone location or in a country that has imposed export restrictions, or that the
establishment manufacturing the drug has a history of violating FDA requirements. This lack of
transparency may make it difficult for hospitals to anticipate supply chain interruptions and drug
shortages. In addition, although drug manufacturers must comply with CGMPs, few incentives
exist for drug manufacturers to engage in mature quality management systems that go beyond
CGMPs. As such, FDA has supported the idea of providing information to purchasers for health
care systems, and potentially consumers more broadly, about the quality management systems of

radiological health products, and tobacco products.
146 FDA, “Fact Sheet: FDA at a Glance.”
147 FDA, “Fact Sheet: FDA at a Glance.”
148 NASEM, “Impact of the Global Medical Supply Chain on SNS Operations and Communications: Proceedings of a
Workshop,” July 18, 2018, p. 10, https://www.ncbi.nlm.nih.gov/books/NBK525648/ doi: 10.17226/25149.
149 See for example, IBISWorld, “Medical Device Manufacturing Industry in the US - Market Research Report,” April
2020, https://www.ibisworld.com/united-states/market-research-reports/medical-device-manufacturing-industry/.
150 CRS Report R46304, COVID-19: China Medical Supply Chains and Broader Trade Issues.
151 FFDCA §502(b)(1) [21 U.S.C. §352(b)(1)]. 21 CFR §201.1(a) and §801.1.
152 ASHP, “Statement for the Record: Improving Safety and Transparency in America’s Food and Drugs,” Energy and
Commerce Subcommittee on Health, January 29, 2020, https://www.ashp.org/Advocacy-and-Issues/Key-Issues/Drug-
Pricing/Energy-and-Commerce-Jan-29.
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the facilities in which drugs are manufactured.153 To implement this idea, the agency would assign
a quality rating to a manufacturing facility and drug companies could, at their discretion, disclose
this rating to purchasers and the general public.154 It is not clear how many manufacturers would
be willing to participate in such a program—particularly those without mature quality
management systems in place—and to disclose publicly a rating that is less than favorable.
Safety concerns regarding drugs can stem from manufacturing quality issues. In contrast, safety
concerns and adverse events regarding certain devices are more commonly associated with device
premarket review mechanisms, which can be less stringent than those for drugs.155 In an effort to
enhance postmarket surveillance of devices, the FDA Amendments Act of 2007 (FDAAA) and
FDASIA required FDA to issue regulations establishing a unique device identification (UDI)
system for devices. The UDI system enables rapid identification of a device and its attributes,
especially those that could affect its safety and effectiveness. Among other things, the UDI
system is intended to reduce medical error, simplify integration of device use information into
data systems, and rapidly identify devices with associated adverse events.156 A device labeler (or
its designated contact) is required to provide FDA with certain information, which is then entered
into the publically available Global Unique Device Identification Database (GUDID).157 Supply
chain data (e.g., location of manufacturing and large-scale distribution data) are generally not
required to be reported as part of the UDI system. The location information of the labeler (or its
designated contact) is reported. This contact information is not always made available to the
public through the GUDID. Distribution data are available only in the context of the number of
individual single-use devices produced in a single device package.158 Furthermore, certain EUA-
authorized PPE distributed and used during the COVID-19 public health emergency have been
exempted from these UDI requirements altogether.159 Although the UDI system is intended to
address the issue of device safety concerns and adverse events, Congress may consider requiring
device labelers to include certain supply chain information on the UDI label and in the GUDID.
Some stakeholders have expressed concern that U.S. consumers do not know where their drugs
are coming from and that they may be unknowingly accepting risks associated with drugs made
in certain countries. Such stakeholders have recommended that this information be publicly
available. For example, the 2019 annual report to Congress of the U.S.-China Economic and
Security Review Commission recommended that “Congress enact legislation requiring drug
companies to list active pharmaceutical ingredients and their countries of origin on labels of
imported and domestically produced finished drug products.”160 Other stakeholders have made

153 FDA, “To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality—Not Just Medicine,” October 24,
2019, https://www.fda.gov/news-events/fda-voices/help-reduce-drug-shortages-we-need-manufacturers-sell-quality-
not-just-medicine, (hereinafter, FDA, “To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality—Not
Just Medicine.”).
154 FDA, “To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality—Not Just Medicine.”
155 See, for example, IOM (Institute of Medicine), Medical Devices and the Public’s Health: The FDA 510(k)
Clearance Process at 35 Years, Washington, DC, July 2011.
156 FDA, “Unique Device Identification System,” 78 Federal Register 58785, September 24, 2013.
157 21 C.F.R. Part 830 subpart E.
158 FDA, Guidance for Industry and Food and Drug Administration Staff: Global Unique Device Identification
Database (GUDID), June 2014, https://www.fda.gov/media/86569/download.
159 FDA, “Emergency Use Authorization (EUA) for Face Masks,” revised letter dated April 24, 2020,
https://www.fda.gov/media/137121/download.
160 U.S.-China Economic and Security Review Commission, 2019 Annual Report to Congress, Chapter 3 Section 3-
Growing U.S. Reliance on China’s Biotech and Pharmaceutical Products, https://www.uscc.gov/annual-report/2019-
annual-report.
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similar recommendations, for example, to require disclosure of country of origin of drugs that are
sold to the Department of Defense.161 Legislation has been introduced that would require
disclosure of this information in some manner for drugs. For example, some proposals would
require that drug labels specify the country of origin of each active ingredient contained in the
drug162 and disclose the location of the manufacturer of each active and inactive ingredient.163
Other proposals would require that the drug manufacturer maintain on its website information
about each country in which a drug is manufactured.164 None of these proposals have been
enacted, and it is unclear how this information would affect consumer decision making,
particularly for sole-source drugs made in a foreign country for which there is no U.S.-made
alternative.
Concluding Observations
For years, stakeholders have expressed concern regarding the transparency and resilience of the
medical product supply chain. In light of the COVID-19 pandemic, these concerns have been
brought to the forefront. Given the potential for disruptions in the supply chain globally, some
have argued that U.S. medical products should be primarily manufactured domestically. However,
others have argued that despite concerns over shortages, particularly shortages of drugs and APIs
said to be made in China, those shortages have not fully transpired as the pandemic has
continued. As a result, some stakeholders argue that the supply chain may be more robust when it
relies on multiple domestic and foreign establishments—as would be the case, for example, if
domestic establishments were severely affected by a surge in COVID-19 cases in a U.S.
community with many medical product manufacturers.
The issues raised in this report pertaining to the U.S. medical product supply chain are generally
described in the context of FDA’s role. The lack of transparency in the medical product supply
chain and purported reliance on foreign-made medical products has been framed as a national
security issue, particularly with respect to U.S. dependence on China and India for medical
products. However, the extent of this dependence is not clear.165
In response to these issues, Congress has introduced legislation that would require various
government and nongovernment entities to study the U.S. medical product supply chain. For
example, the recently enacted CARES Act requires the NASEM to examine and report on the
security of the U.S. medical product supply chain, including U.S. dependence on critical drugs
and devices from other countries.166 The report must assess and evaluate U.S. dependence on
critical drugs and devices from other countries; provide recommendations (e.g., a plan to improve
resiliency of the supply chain); and address any supply vulnerabilities or potential disruptions that

161 Testimony of Rosemary Gibson, Author of “China Rx: Exposing the Risks of America’s Dependence on China for
Medicine” before the U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, 116th
Cong., 1st sess., October 30, 2019, https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/
files/documents/Testimony-Gibson-API_103019.pdf.
162 S. 3757 (116th Congress), §2 Subsection (c).
163 S. 3633 (110th) Congress.
164 S. 3105 (115th Congress).
165 For example, FDA data indicate that 13% of facilities that make API for the U.S. market are located in China and
19% are located in India, but the volume of drugs manufactured in these countries is unknown. See FDA, Testimony of
Judith McMeekin, Mark Abdoo, and Douglas Throckmorton, “CDER COVID-19 and Beyond: Oversight of the FDA’s
Foreign Drug Manufacturing Inspection Process.”
166 P.L. 116-136, §3101.
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would significantly affect or pose a threat to public health or national security, as appropriate. In
conducting the study and developing the report, NASEM must consider input from federal
departments and agencies and consult with stakeholders through public meetings and other forms
of engagement. In addition, legislation has been introduced that would require the Secretaries of
HHS, Homeland Security, and Defense to individually conduct annual risk assessments of the
medical product supply chain and to submit those assessment to Congress.167 Although drug and
device manufacturers are required to report various supply chain information to FDA, this
information generally has not been required to be shared with other agencies or departments. As
such, legislation has been introduced that would require FDA to share certain supply chain
information with the Assistant Secretary for Preparedness and Response (ASPR) and the
Department of Defense.168
Various legislative proposals related to the medical product supply chain have been introduced in
the 116th Congress (see Appendix B). These proposals include, among other things,
commissioning studies; expanding manufacturer reporting requirements and information sharing
across agencies; restricting federal health programs from purchasing foreign-made drugs; and
expanding and incentivizing use of advanced manufacturing technologies for domestic drug and
device manufacturing.

167 See, for example, S. 3780 (116th Congress).
168 See, for example, S. 3781 (116th Congress).
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Appendix A. Selected Laws Authorizing and
Amending Registration and Reporting
Requirements
Year
Law
Summaries of Selected Provisions
1938
The Federal Food, Drug,
Drug Approval Requirements: Required that a drug is demonstrated to be
and Cosmetic Act
safe prior to marketing. The FFDCA, as subsequently amended,
(FFDCA, P.L. 75-717)
authorizes FDA to regulate the safety and effectiveness of drugs and
devices (and other products).
1962
The Kefauver-Harris Drug Drug Establishment Registration: Established new FFDCA Section 510
Amendments to the
requiring that domestic entities engaged in the manufacture of drugs
FFDCA (P.L. 87-781)
annually register their establishments with the Secretary and allowing
foreign entities engaged in the manufacture of drugs to register their
establishments pursuant to regulations promulgated by the Secretary.
1972
The Drug Listing Act of
Drug Listing: Amended FFDCA Section 510 to add a subsection (j)
1972 (P.L. 92-387)
requiring registrants to file with the Secretary biannually a list of drugs
being manufactured by them for commercial distribution.
1976
The Medical Device
Device Establishment Registration and Listing: Amended FFDCA Section
Amendments of 1976
510 to extend registration and listing requirements to device
(MDA, P.L. 94-295)
manufacturers.
1997
The FDA Modernization
Foreign Drug Establishment Registration and Listing: Amended FFDCA
Act (FDAMA, P.L. 105-
Section 510(i) to require (rather than allow) establishments that
115 )
manufacture drugs or devices in foreign countries for importation into the
United States to register with the Secretary and to provide specified drug
and device listing information.
Notification of Drug Discontinuance: Created FFDCA Section 506C to
require that a sole-source manufacturer of an approved drug that is life-
supporting, life-sustaining, or intended for use in the prevention or
treatment of a debilitating disease or condition to notify the Secretary of
any discontinuance in the manufacture of the drug.
2002
The Public Health
Annual Registration of Foreign Establishments: Amended FFDCA Section
Security and Bioterrorism
510(i) to require foreign drug and device establishments to register with
Preparedness Response
the Secretary annually and expanded the information that must be
Act (P.L. 107-188)
provided during registration.
Importation Statement of Registration: Amended FFDCA Section 801 to
allow an imported drug or device to be refused admission into the United
States if the importer, owner, or consignee does not, at the time of
offering the drug or device for import, submit to the Secretary a
statement that identifies the registration under FFDCA Section 510(i) of
each establishment involved in the manufacture of that drug or device.
2002
Medical Device User Fee
Electronic Registration: Amended FFDCA Section 510 to require that
and Modernization Act of
facility registration is submitted to the Secretary electronically.
2002 (MDUFMA, P.L.
Inspections by Accredited Persons: Amended FFDCA Section 510 to
107-250)
require the Secretary to accredit persons to conduct surveillance
inspections of device establishments.
2007
The FDA Amendments
Registration of Domestic Device Establishments: Amended FFDCA
Act (FDAAA, P.L. 110-85) Section 510(b) to require that annual registration of domestic device
establishments takes place during the period beginning on October 1 and
ending on December 31 of each year.
Registration of Foreign Establishments: Amended FFDCA Section 510(i)
to require foreign establishments to register upon first engaging in the
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Year
Law
Summaries of Selected Provisions
manufacture of a drug or device, and maintained the requirement to
register annually thereafter.
Device Listing: Amended FFDCA Section 510(j) to require submission of
annual, rather than biannual, listing information for devices.
Electronic Registration and Listing: Amended FFDCA Section 510 to
require that registration and listing information be submitted to the
Secretary electronically unless waived by the Secretary.
Unique Device Identification System: Amended FFDCA Section 519 to
require FDA to promulgate regulations establishing a unique device
identification system that requires the label of devices to bear a unique
identifier.
2012
The FDA Safety and
Registration of Establishments: Amended FFDCA Section 510 to require
Innovation Act (FDASIA,
that annual registration of domestic and foreign drug establishments, as
P.L. 112-144), Title VII
well as foreign device establishments, takes place during the period
beginning on October 1 and ending on December 31 of each year; that
the registrant provide the unique facility identifier (UFI) of each such drug
establishment and a point of contact email address; and that the Secretary
specify the UFI system for registration of domestic and foreign drug
establishments.
Drug Listing and Excipient Information: Amended FFDCA Section 510(j)
to require that listing information include the name and place of business
of each manufacturer of an excipient of the listed drug.
Electronic Registration and Listing: Amended FFDCA Section 510 to
require the Secretary to maintain an electronic database to enable FDA
personnel to search the database by any field of information submitted in
a registration and that uses the UFI system.
Risk-based Inspection Frequency: Amended FFDCA Section 510(h) to
require FDA to conduct surveillance inspections of foreign and domestic
drug and device establishments on a risk-based schedule.
Records for inspection: Amended FFDCA Section 704(a) to allow the
Secretary to require that drug establishments submit records or other
information subject to inspection in advance prior to or in lieu of an
inspection.
Notification of Interruption of Discontinuance of Drug Production:
Amended FFDCA Section 506C to require the manufacturer of a drug
that is life-supporting, life-sustaining, or intended for use in the prevention
or treatment of a debilitating disease or condition to notify the Secretary
of any discontinuance or interruption in its manufacturing.
Unique Device Identifier: Amended FFDCA Section 519 to require the
Secretary to promulgate regulations regarding the unique device
identification system on a specified timeline.
2013
Drug Quality and Security
Drug Supply Chain Security: Amended FFDCA Ch. V to add a new
Act (DQSA, P.L. 113-54)
subchapter H (“Pharmaceutical Distribution Supply Chain”) requiring
trading partners within the drug supply chain to maintain and exchange
certain transaction information with respect to a drug, among other
things.
2017
FDA Reauthorization Act
Improvements to Inspections Process for Device Establishments:
(FDARA, P.L. 115-52)
Amended FFDCA Section 704 to require the Secretary to review and
update processes and standards applicable to domestic and foreign device
establishment inspections, other than for-cause inspections, and issue
guidance implementing these changes. Such standards must provide for,
among other things, pre-announcing the inspection within a reasonable
time before it takes place.
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Year
Law
Summaries of Selected Provisions
2020
The Coronavirus Aid,
Notification of Interruption of Discontinuance of API Production:
Relief, and Economic
Amended FFDCA Section 506C to require a manufacturer to notify the
Security Act (CARES Act, Secretary of any permanent discontinuance or interruption in the
P.L. 116-136)
manufacture of an API—not just the finished drug—that is likely to lead to
a meaningful disruption in the supply of the API of such drug.
Additional Drug Manufacturer Reporting Requirements: Amended FFDCA
Section 510(j) to require a registrant to report annually on the amount of
each listed drug manufactured for commercial distribution.
Notification of Interruption of Discontinuance of Device Production:
Added FFDCA Section 506J to require a manufacturer to notify FDA,
prior to or during a public health emergency, of any permanent
discontinuance or interruption in the manufacture of a device that is likely
to lead to a meaningful disruption in the supply of the device.
Source: Created by CRS.
Notes: This table is meant to summarize key laws authorizing and amending the reporting and registration
requirements described in this report. Summaries were written by the authors of this report and are not
intended to be comprehensive. This table does not include the Biologics Control Act (P.L. 57-244), enacted in
1902, which required annual licensure by the Public Health Service (PHS) of establishments manufacturing
biological products for interstate commerce. The Biologics Control Act was revised and recodified (42 U.S.C.
§262) when the Public Health Service Act (PHSA) was enacted in 1944. The PHSA provides that a biological
product licensed for marketing under the PHSA is also subject to regulation (though not approval) under the
FFDCA. As such, biologics are generally subject to the registration and listing requirements in FFDCA Section
510.
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Appendix B. Selected Medical Product Supply
Chain Legislation Introduced in the 116th Congress
Bill
Bill Title
Number
Summary
Prescription for American Drug
H.R. 6670
Would require the HHS Secretary to enter into a contract with
Independence Act of 2020
NASEM to establish a committee of experts on drug
production; conduct a public symposium to analyze U.S.
dependence on foreign-made drugs and recommend strategies
to end such dependence; and submit a report to Congress on
the symposium’s proceedings.
Commission on America’s
H.R. 6282;
Would require the HHS Secretary to enter into a contract with
Medical Security Act
S. 3478
NASEM to assess and evaluate U.S. dependence on critical
drugs and devices that are sourced or manufactured outside of
the United States and provide recommendations to address the
resiliency of the supply chain for critical drugs and devices.
Protecting Our Pharmaceutical
S. 3635;
Would require the HHS Secretary to (1) compile and maintain
Supply Chain from China Act of
H.R. 6482
a list of all FDA-approved drugs and any API in such drugs that
2020
are manufactured outside of the United States and (2) maintain
a separate list of drugs based on the first list that are
exclusively manufactured in China, or use API or inactive
ingredients manufactured in China. Would deem a drug
misbranded if its labeling does not specify the country of origin
of each API in the drug. Would prohibit the use of federal funds
for the purchase of, or reimbursement for, drugs manufactured
in China.
Take Responsibility for Workers
H.R. 6379
Would require manufacturers or certain sterilizers of essential
and Families Act
devices to report to the HHS Secretary a permanent
discontinuance or interruption in manufacturing or other
circumstances that would lead to a shortage or meaningful
disruption in the supply of the device in the United States.
Essential devices would be defined as those critical to
preventing, screening, diagnosing, treating, or mitigating the
spread of a disease or condition during a public health
emergency declared under PHSA Section 319. The HHS
Secretary would be required to make a list of essential devices
publicly available on FDA’s website.
Would authorize the HHS Secretary to destroy counterfeit
devices valued at $2,500 or less (or such higher amount as the
Secretary of the Treasury may set by regulation).
Would explicitly require establishments in a foreign country
engaged in the manufacture of a drug (including API) to register
with the HHS Secretary, regardless of whether the drug or API
undergoes further manufacture outside the United States prior
to importation. Would expand the information that must be
submitted as part of drug listing to include certification that the
registrant has (1) identified every other establishment where
manufacturing is performed for the drug and (2) notified each
known foreign establishment manufacturing the drug or API of
its inclusion on the list and obligation to register. Would amend
the reporting requirement on quantity of drug manufactured
added by the CARES Act to make it quarterly instead of annual
and would allow the Secretary to require this information to be
further delineated.
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Bill
Bill Title
Number
Summary
Would require the HHS Secretary, acting through FDA, to
designate an institution of higher education as a National
Center of Excellence in Continuous Pharmaceutical
Manufacturing.
The Pharmaceutical
S. 3781
Would require drug and device manufacturers to notify the
Accountability, Responsibility,
HHS Secretary of (1) any increases in demand of a drug or
and Transparency (PART) Act
device that they wil be unable to meet and (2) any export
restrictions or other limitations imposed on manufacturing or
export of a drug (or its APIs) or device (or its components) by
the country in which it is manufactured.
Would explicitly require establishments within a foreign
country engaged in the manufacture of a drug (including API) or
device to register with the HHS Secretary, regardless of
whether the drug, API, or device undergoes further
manufacture outside the United States prior to importation.
Would expand the information that must be submitted as part
of drug listing to include certification that the registrant has (1)
identified every other establishment where manufacturing is
performed for the drug and (2) notified each known foreign
establishment manufacturing the drug or API of its inclusion on
the list and obligation to register. Would amend the reporting
requirement on quantity of drug manufactured added by the
CARES Act to make it quarterly instead of annual and would
expand the information that must be reported, including to
devices.
Would require FDA to share with ASPR and the Assistant
Secretary of Defense for Health Affairs specified drug and
device manufacturing data.
The Heroes Act
H.R. 6800
Would explicitly require establishments within a foreign
country engaged in the manufacture of a drug (including API) to
register with the HHS Secretary, regardless of whether the
drug or API undergoes further manufacture outside the United
States prior to importation. Would expand the information
that must be submitted as part of drug listing to include
certification that the registrant has (1) identified every other
establishment where manufacturing is performed for the drug
and (2) notified each known foreign establishment
manufacturing the drug or API of its inclusion on the list and
the obligation to register. Would amend the reporting
requirement on quantity of drug manufactured added by the
CARES Act to make it quarterly instead of annual.
Limit Ongoing Shortages and
H.R. 6660
Would require drug manufacturers to conduct risk assessments
Stabilize Supply Act of 2020,
to identify vulnerabilities to the supply of a drug and to develop
LOSS Act
risk mitigation plans. Would expand required reporting of
manufacturing interruptions and discontinuances to APIs.
Safe and Secure Medicine Supply
H.R. 6885
Would prohibit the importation of a drug or device that was
for Hardworking Americans Act
manufactured at a banned foreign facility, which would be
of 2020
defined in statute. Would also impose duties on drugs from
certain countries and create a fund in the Treasury for
purposes of incentivizing drug or device companies to increase
U.S. manufacturing capacity.
Would require the HHS Secretary to (1) compile and maintain
a registry of all FDA-approved drugs and any API in such drugs
that are manufactured outside of the United States and (2)
maintain a separate list of drugs included in the registry for
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Bill
Bill Title
Number
Summary
which 50% or more of their API are manufactured outside the
United States. Would deem a drug misbranded if its labeling
does not specify the country of origin of each API in the drug.
Manufacturing API, Drugs, and
H.R. 6930
Would require the HHS Secretary to report to Congress on
Excipients (MADE) in America
barriers to domestic manufacturing of APIs, drugs, and devices;
Act of 2020
expand or establish initiatives for mutual sharing of review and
inspection criteria between drug regulatory authorities; report
annually on select drug and device inspections conducted in the
prior year; continue the program to evaluate and approve new
drug manufacturing technologies that are included in drug
applications; and designate certain methods of drug
manufacturing as advanced manufacturing technologies and take
actions to expedite the development and implementation of
such method of manufacture for purposes of approval. Would
establish a tax credit for drug and device production activities
in distressed zones.
Buy American Medical Supply
H.R. 6879
Would require the HHS Secretary to establish and implement a
Chain Act of 2020
program to maintain U.S. industrial production capacity for
items in the SNS “at a level needed to ensure that domestic
needs can be met during a surge in worldwide demand due to a
pandemic or other widespread emergency.”
Help Onshore Manufacturing
S. 3780
Would establish within ASPR the Center for Domestic
Efficiencies for Drugs and
Advanced Manufacturing of Critical Drugs and Devices
Devices Act; HOME Act
(Center); require the Center to compile a list of critical drugs
and devices to be prioritized for domestic advanced
manufacturing and increased domestic production; and establish
and oversee a grant and forgivable loan program to support
advanced manufacturing and domestic production.
Would require FDA to expedite supplemental applications for
drugs on the critical drugs and devices list, if approval of the
supplemental application would enable incorporation of a
manufacturing change intended to enhance drug quality,
increase domestic manufacturing of the drug, or incorporate
the use of advanced manufacturing.
Would allow HHS and DOD to enter into contracts to
purchase critical drugs or devices in order to invest in
preparedness, the SNS, and mitigate drug and device shortages.
Would require the Secretaries of DHS, HHS, and DOD to
each conduct separate independent risk assessments of the
medical supply chain and report findings to Congress.
Medical Supply Chain Security
H.R. 6049;
Would require manufacturers of certain devices to notify the
Act
S. 3343
HHS Secretary of a permanent discontinuance or interruption
in the manufacture of the device that would lead to a
meaningful disruption in its supply in the United States. Would
require the HHS Secretary, as appropriate, to expedite the
review of a device subject to a PMA in which there is, or likely
to be, a shortage of the device.
Would require manufacturers of drugs or devices that have
submitted a notification regarding a permanent discontinuance
or interruption to report on an annual basis, or more
frequently at the request of the HHS Secretary, information
related to manufacturing capacity of such drug or device.
Would require device manufacturers that have submitted a
notification of permanent discontinuance or interruption to
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Bill
Bill Title
Number
Summary
report to select committees of Congress information related to
device shortages on an annual basis.
Preventing Essential Medical
S. 3468
Would require manufacturers of essential devices to notify the
Device Shortages Act of 2020
HHS Secretary of a permanent discontinuance or interruption
in the manufacture of the device that would lead to a
meaningful disruption in its supply in the United States. The
term essential device would be defined in regulations that would
be required to be promulgated one year after enactment of the
act.
Would allow for the HHS Secretary to expedite the review of
certain premarket applications for devices that are or are likely
to be in shortage. The HHS Secretary would be required to
publish a public list, updated annually, of essential devices that
had received expedited premarket review, among other things.
Would additionally require the HHS Secretary to maintain a
public up-to-date list of devices that are determined to be in
shortage in the United States.
Would require a GAO report examining FDA intra-agency
coordination, communication, and decision-making in assessing
device shortages, including FDA efforts to mitigate any essential
device shortages.
To amend certain provisions in
H.R. 6062
Would require manufacturers of certain devices to notify the
the Federal Food, Drug, and
HHS Secretary of a permanent discontinuance or interruption
Cosmetic Act relating to the
in the manufacture of the device that would lead to a
discontinuance or interruption in
meaningful disruption in its supply in the United States. Would
the production of life-saving
require the HHS Secretary, as appropriate, to expedite select
drugs so as to apply such
premarket review applications of devices in which there is, or is
provisions with respect to life-
likely to be, a shortage.
saving devices, and for other
Would require device manufacturers that have submitted a
purposes.
notification of permanent discontinuance or interruption to
report to select committees of Congress information related to
device shortages on an annual basis.
Would require the HHS Secretary to maintain a public up-to-
date list of devices that are determined to be in shortage in the
United States.
Would allow for importation of devices not cleared or
approved by FDA in the case of a shortage of such device.
Safeguarding Therapeutics Act
H.R. 5663
Would authorize the HHS Secretary to destroy a counterfeit
device valued at $2,500 or less (or such higher amount as the
Secretary of the Treasury may set by regulation).
Safe Medicine Act
H.R. 5982
Would require the HHS Secretary, in consultation with other
appropriate federal departments and agencies, to submit to
Congress a report on vulnerabilities to the U.S. medicine
supply chain.
Would allow FDA to issue a temporary order deeming certain
drugs to be misbranded if the drug or its APIs are
manufactured in a country that FDA determines may be
producing contaminated drugs or APIs as a result of systemic
problems of supervision in manufacturing and the labeling does
not bear a boxed warning of the potential for contamination.
Securing America’s Medicine
S. 3432;
Would require the HHS Secretary to continue the program to
Cabinet Act of 2020
H.R. 6708
evaluate and approve new drug manufacturing technologies that
are included in drug applications; to designate certain methods
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Bill
Bill Title
Number
Summary
of drug manufacturing as advanced manufacturing technologies
and take actions to expedite the development and
implementation of such method of manufacture for purposes of
approval of drugs and biologics; and to designate eligible
institutions of higher education as National Centers of
Excellence in Advanced Pharmaceutical Manufacturing.
COVID-19 Emergency Medical
H.R. 6858
“To enhance authorities under the Defense Production Act of
Supplies Enhancement Act of
1950 to respond to the COVID–19 emergency, to provide
2020
additional oversight of such authorities, and to require a
strategy on securing supply chains for medical materials, and for
other purposes.”
Medical Supply Chain Emergency
S. 3568,
Would require the President to use authorities under the
Act of 2020
H.R. 6390
Defense Production Act of 1950 to require emergency
production of medical equipment (e.g., N95 respirators,
ventilators) to address the COVID-19 pandemic, and to
coordinate and direct the allocation of medical equipment
based on requests from governors and the needs of the states,
as specified.
Medical Supplies for Pandemics
H.R. 6531
Would require the HHS Secretary to “enhance medical supply
Act of 2020
chain elasticity and establish and maintain domestic reserves of
critical medical supplies (including personal protective
equipment, ancil ary medical supplies, and other applicable
supplies required for the administration of drugs, vaccines and
other biological products, medical devices, and diagnostic tests)
by creating incentives for manufacturers of medical supplies” to
increase emergency stock of critical medical supplies,
geographically diversify production, and take other specified
actions.
Securing America’s
H.R. 6731
Would allow an executive agency to purchase a drug only if the
Pharmaceutical Supply Chain Act
drug is over 50% sourced, manufactured, and assembled in the
United States, except for during emergencies or if the drug is
not available in sufficient quantity or quality as over 50%
sourced, manufactured, and assembled in the United States.
Also would require modification to trade agreements to
exclude coverage of essential medicines and medical
countermeasures.
Strengthening America’s Supply
S. 3538,
Would require the DOD Secretary, in coordination with the
Chain and National Security Act
H.R. 6393
HHS Secretary, to submit to Congress a classified report on
DOD’s reliance on drugs made at least in part in certain
countries; modify how country of origin is determined for
drugs; and require the sponsor of a drug to submit, as part of
the annual postmarket reporting requirements, information
about the source of each active and inactive ingredient in the
drug and the percentage of the aggregate amounts of such
ingredients from each source.
Country Of Origin Labeling
S. 3707
Would require disclosure of country-of-origin labeling for
(COOL) Online Act
products “introduced, sold, advertised, or offered for sale” on
the internet and would prohibit false and misleading
representation of U.S. origin in any labeling, advertising, or
other promotional materials of a product.
National Defense Authorization
H.R. 2500
Section 739 would require the DOD Secretary to conduct a
Act for FY2020
study on the effectiveness of readiness contracts managed by
the Customer Pharmacy Operations Center of the Defense
Logistics Agency in meeting the military’s drug supply needs, as
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Bill
Bill Title
Number
Summary
specified, including “an analysis of how the contractual
approach to manage drug shortages for military health care can
be a model for responding to drug shortages in the civilian
health care market in the United States.”
Securing America’s Medical
S. 3942
Would establish the Chief Pharmaceutical and Medical Supply
Supply Chain and Advancing the
Chain Negotiator in the Office of the United States Trade
Production of Life Saving
Representative, who would be responsible for “conducting
Medicines Act
trade negotiations and enforcing trade agreements related to
acts, policies, and practices of foreign governments that fail to
appropriately reward United States innovation with respect to
pharmaceuticals, to advance domestic production of life-saving
medicines, and to secure the United States medical supply chain
to eliminate reliance on foreign governments, and for other
purposes.”
PPE Supply Chain Transparency
S. 4158
Would require the Administrator of FEMA, in consultation with
Act of 2020.
the HHS Secretary, to submit to select committees of
Congress and to make publicly available a report on the supply
chain for PPE during the COVID-19 pandemic.
Source: Created by CRS.
Notes: Bil s were identified by searching Congress.gov for legislation introduced in the 116th Congress that
would amend 21 U.S.C. §360, 21 U.S.C. §356c, or 21 U.S.C. §356j, and includes terms related to drugs or
medical devices and the supply chain. The authors of this report selected relevant bil s from the result lists. Note
that these searches may not have identified all applicable legislation. Bil summaries were written by the authors
of this report to describe key provisions and are not intended to be comprehensive.
Abbreviations: API=Active Pharmaceutical Ingredient; ASPR=Assistant Secretary for Preparedness and
Response; CARES=Coronavirus Aid, Relief, and Economic Security; DOD=Department of Defense;
DHS=Department of Homeland Security; FDA=Food and Drug Administration; FEMA=Federal Emergency
Management Agency; GAO=Government Accountability Office; HHS=Department of Health and Human
Services; NASEM=National Academies of Science, Engineering and Medicine; PPE=Personal Protective
Equipment; PHSA=Public Health Service Act; PMA=Premarket Approval; and SNS=Strategic National Stockpile.
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Appendix C. Selected Medical Product Supply
Chain Resources
Congressional Hearings
The following congressional hearings feature testimony from Food and Drug Administration
(FDA) officials regarding FDA oversight of the medical supply chain.
 U.S. Congress, Senate Finance Committee, COVID-19 and Beyond: Oversight of
the FDA’s Foreign Drug Manufacturing Inspection Process, hearings, 116th
Congress, 2nd sess., June 2, 2020, https://www.finance.senate.gov/hearings/covid-
19-and-beyond-oversight-of-the-fdas-foreign-drug-manufacturing-inspection-
process.
 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on
Oversight and Investigations, Securing the U.S. Drug Supply Chain: Oversight of
FDA’s Foreign Inspection Program, hearings, 116th Cong., 1st sess., December
10, 2019, https://energycommerce.house.gov/committee-activity/hearings/
hearing-on-securing-the-us-drug-supply-chain-oversight-of-fda-s-foreign.
 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on
Health, Safeguarding Pharmaceutical Supply Chains in a Global Economy,
hearings, 116th Cong., 1st sess., October 30, 2019,
https://energycommerce.house.gov/committee-activity/hearings/hearing-on-
safeguarding-pharmaceutical-supply-chains-in-a-global-economy.
 U.S. Congress, U.S. - China Economic and Security Review Commission,
Exploring the Growing U.S. Reliance on China’s Biotech and Pharmaceutical
Products, hearings, 116th Cong., 1st sess., July 31, 2019, https://www.uscc.gov/
hearings/exploring-growing-us-reliance-chinas-biotech-and-pharmaceutical-
products.
Food and Drug Administration (FDA)
Reports
 U.S. Food and Drug Administration, Drug Shortages Task Force, Drug
Shortages: Root Causes and Potential Solutions, Updated February 21, 2020,
https://www.fda.gov/media/131130/download.
 U.S. Food and Drug Administration, Office of Pharmaceutical Quality (OPQ),
Report on the State of Pharmaceutical Quality, Fiscal Year 2019,
https://www.fda.gov/media/138711/download.
 U.S. Food and Drug Administration ,Office of Pharmaceutical Quality (OPQ),
Report on the State of Pharmaceutical Quality, Fiscal Year 2018,
https://www.fda.gov/media/125001/download.
News Releases and Communications
 U.S. Food and Drug Administration, Coronavirus (COVID-19) Update: FDA
prepares for resumption of domestic inspections with new risk assessment system,
July 10, 2020, https://www.fda.gov/news-events/press-announcements/
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coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-
new-risk-assessment-system.
 U.S. Food and Drug Administration, Coronavirus (COVID-19) Update: FDA
updates on surveillance inspections during COVID-19, May 11, 2020,
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-updates-surveillance-inspections-during-covid-19.
 U.S. Food and Drug Administration, FDA at a Glance: Regulated Products and
Facilities, October 2019, https://www.fda.gov/media/131874/download.
 U.S. Food and Drug Administration, Statement on concerns with medical device
availability due to certain sterilization facility closures, October 25, 2019,
https://www.fda.gov/news-events/press-announcements/statement-concerns-
medical-device-availability-due-certain-sterilization-facility-closures.
 U.S. Food and Drug Administration, CDER Conversation: Assuring Drug
Quality Around the Globe, May 10, 2019, https://www.fda.gov/drugs/news-
events-human-drugs/cder-conversation-assuring-drug-quality-around-globe.
 U.S. Food and Drug Administration, Statement from FDA Commissioner Scott
Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research
Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong
oversight of generic drug quality issues domestically and abroad, February 22,
2019, https://www.fda.gov/news-events/press-announcements/statement-fda-
commissioner-scott-gottlieb-md-and-director-fdas-center-drug-evaluation-and-
research-0.
Government Accountability Office (GAO)
Drugs
 U.S. Government Accountability Office, COVID-19 Complicates Already
Challenged FDA Foreign Inspection Program, GAO-20-626T, June 2, 2020,
https://www.gao.gov/products/GAO-20-626T.
 U.S. Government Accountability Office, Preliminary Findings Indicate
Persistent Challenges with FDA Foreign Inspections, GAO-20-262T, December
2019, https://www.gao.gov/products/GAO-20-262T.
 U.S. Government Accountability Office, FDA Should Take Additional Steps to
Address Factors That May Affect Approval Rates in the First Review Cycle,
GAO-19-565, August 2019, https://www.gao.gov/products/GAO-19-565.
 U.S. Government Accountability Office, FDA Has Improved Its Foreign Drug
Inspection Program, but Needs to Assess the Effectiveness and Staffing of Its
Foreign Offices, GAO-17-143, December 2016, https://www.gao.gov/products/
GAO-17-143.
 U.S. Government Accountability Office, FDA Has Conducted More Foreign
Inspections and Begun to Improve Its Information on Foreign Establishments,
but More Progress Is Needed, GAO-10-961, September 2010,
https://www.gao.gov/products/GAO-10-961.
 U.S. Government Accountability Office, Better Data Management and More
Inspections Are Needed to Strengthen FDA’s Foreign Drug Inspection Program,
GAO-08-970, September 2008, https://www.gao.gov/products/GAO-08-970.
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 U.S. Government Accountability Office, Preliminary Findings Suggest Recent
FDA Initiatives Have Potential, but Do Not Fully Address Weaknesses in Its
Foreign Drug Inspection Program, GAO-08-701T, April 2008,
https://www.gao.gov/products/GAO-08-701T.
 U.S. Government Accountability Office, Preliminary Findings Suggest
Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers,
GAO-08-224T, November 2007, https://www.gao.gov/products/GAO-08-224T.
 U.S. Government Accountability Office, Improvements Needed in the Foreign
Drug Inspection Program, HEHS-98-21, March 1998, https://www.gao.gov/
products/HEHS-98-21.
Devices
 U.S. Government Accountability Office, Shortcomings in FDA’s Premarket
Review, Postmarket Surveillance, and Inspections of Device Manufacturing
Establishments, GAO-09-370T, June 2009, https://www.gao.gov/products/GAO-
09-370T.
 U.S. Government Accountability Office, FDA Faces Challenges in Conducting
Inspections of Foreign Manufacturing Establishments, GAO-08-780T, May 14,
2008, https://www.gao.gov/products/GAO-08-780T.
 U.S. Government Accountability Office, Challenges for FDA in Conducting
Manufacturer Inspections, GAO-08-428T, January 2008, https://www.gao.gov/
products/GAO-08-428T.
 U.S. Government Accountability Office, Status of FDA’s Program for
Inspections by Accredited Organizations, GAO-07-147, January 2007,
https://www.gao.gov/products/GAO-07-157.

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Appendix D. Acronyms Used in this Report

ACE
Automated Commercial Environment System
ANDA
Abbreviated New Drug Application
API
Active Pharmaceutical Ingredient
ASPR
Assistant Secretary for Preparedness and Response
BLA
Biologic License Application
BsUFA
Biosimilar User Fee Act
CARES
Coronavirus Aid, Relief, and Economic Security Act
CBER
Center for Biologics Evaluation and Research
CBP
U.S. Customs and Border Protection
CDER
Center for Drug Evaluation and Research
CDRH
Center for Devices and Radiological Health
CGMP
Current Good Manufacturing Practice
CMO
Contract Manufacturing Organization
COVID-19
Coronavirus Disease 2019
DECRS
Drug Establishment Current Registration Site
DHF
Device History File
DSCSA
Drug Supply Chain Security Act
DQSA
Drug Quality and Security Act
EIR
Establishment Inspection Report
EPA
U.S. Environmental Protection Agency
FDA
Food and Drug Administration
FDAAA
FDA Amendments Act of 2007
FDAMA
Food and Drug Administration Modernization Act of 1997
FDASIA
FDA Safety Innovation Act of 2012
FDF
Finished Dosage Form
FFDCA
Federal Food, Drug, and Cosmetic Act
FOIA
Freedom of Information Act
GAO
Government Accountability Office
GDUFA
Generic Drug User Fee Amendments
GUDID
Global Unique Device Identification Database
HHS
Department of Health and Human Services
MDUFA
Medical Device User Fee Amendments
MRA
Mutual Recognition Agreement
NAI
No Action Indicated
NASEM
National Academies of Sciences, Engineering, and Medicine
NDA
New Drug Application
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NDC
National Drug Code
OAI
Official Action Indicated
ORA
Office of Regulatory Affairs
OTC
Over-the-Counter
PHSA
Public Health Service Act
PMA
Premarket Approval
QS
Quality System
SSM
Site Selection Model
UDI
Unique Device Identification
VAI
Voluntary Action Indicated

Author Information

Victoria R. Green
Kate M. Costin
Analyst in Health Policy
Research Librarian

Agata Dabrowska

Analyst in Health Policy

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
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under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other
than public understanding of information that has been provided by CRS to Members of Congress in
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