Reporting and Mitigating Animal Drug Shortages

Contains Nonbinding Recommendations

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Reporting and Mitigating Animal Drug
Shortages during the COVID-19 Public
Health Emergency
Guidance for Industry
May 2020

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine

Preface
Public Comment
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public
health emergency. This guidance is being implemented without prior public comment because
the Food and Drug Administration (FDA or Agency) has determined that prior public
participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately, but it remains
subject to comment in accordance with the Agency’s good guidance practices.
Comments may be submitted at any time for Agency consideration. Submit written comments to
the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.
All comments should be identified with the docket number FDA-2020-D-1140 and complete
title of the guidance in the request.

Additional Copies
Additional copies are available from the FDA webpage titled “COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,” available at
https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-relatedguidance-documents-industry-fda-staff-and-other-stakeholders, the FDA webpage titled “Search
for FDA Guidance Documents,” available at https://www.fda.gov/regulatory-information/searchfda-guidance-documents, and the Center for Veterinary Medicine webpage titled “Guidance for
Industry,” available at https://www.fda.gov/animal-veterinary/guidance-regulations/guidanceindustry. You may also send an e-mail request to AskCVM@fda.hhs.gov to receive a copy of
the guidance. Please include the document number FDA-2020-D-1140 and complete title of the
guidance in the request.

Questions
For questions about this document, contact AskCVM@fda.hhs.gov.

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Table of Contents
Preface ............................................................................................................................................ 2
I.

Introduction ........................................................................................................................ 4

II.

Background ......................................................................................................................... 5

III.

Discussion ............................................................................................................................ 5
1. Why should animal drug shortages be reported to FDA? ...................................... 5
2. Who should report animal drug shortages to FDA? ............................................... 6
3. How and when should an animal drug shortage be reported? ............................... 6
4. What information should be included in the report? .............................................. 6
5. What information should a sponsor provide to support the acceptability of an
alternate manufacturer or a new manufacturing facility proposed to prevent
or mitigate a shortage? ............................................................................................... 6
6. What information should a sponsor provide to support the acceptability of a
CMC supplement or a CMC technical section for other types of manufacturing
changes to prevent or mitigate a product shortage? ............................................... 7
7. What are examples of steps FDA may take to prevent or mitigate a shortage? ... 7

IV.

References ........................................................................................................................... 7

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Reporting and Mitigating Animal
Drug Shortages during the COVID-19
Public Health Emergency
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency)
on this topic. It does not establish any rights for any person and is not binding on FDA or the public.
You can use an alternative approach if it satisfies the requirements of the applicable statutes and
regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as
listed on the title page.

I.

Introduction

FDA plays a critical role in protecting the United States from threats such as emerging infectious
diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to
providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide recommendations on the information sponsors should
submit to the Center for Veterinary Medicine (CVM) to report and mitigate animal drug shortages
for the duration of the public health emergency. For purposes of this guidance, an animal drug
shortage includes an actual or potential shortage, including a disruption or anticipated disruption in
the supply chain for the drug product or any component of the drug product (including the active
pharmaceutical ingredient (API), drug substance intermediates, inactive ingredients, or components
of containers and closures) for the U.S. market.
This policy is intended to remain in effect only for the duration of the public health emergency
related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January
31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April
26, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2)
of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
Given this public health emergency, and as discussed in the Notice in the Federal Register of
March 25, 2020 (85 FR 16949), titled “Process for Making Available Guidance Documents Related
to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-0325/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment because
FDA has determined that prior public participation for this guidance is not feasible or appropriate
(see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented
immediately, but it remains subject to comment in accordance with the Agency’s good guidance
practices.
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In general, FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic
and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance means that something is
suggested or recommended, but not required.

II.

Background

There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has
been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019”
(COVID-19). On January 31, 2020, the HHS issued a declaration of a public health emergency
related to COVID-19 and mobilized the Operating Divisions of HHS. 1 In addition, on March 13,
2020, the President declared a national emergency in response to COVID-19. 2
FDA has been closely monitoring the animal drug supply chain for supply disruptions or shortages
in the United States during the COVID-19 pandemic. FDA is issuing this guidance to assist
sponsors in providing FDA timely, informative notifications about changes in the production of
animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of
these products.

III. Discussion
This guidance provides recommendations on the voluntary information for sponsors to submit to
the Center for Veterinary Medicine (CVM) to report and mitigate animal drug shortages for the
duration of the public health emergency declared by the Secretary of Health and Human Services
(HHS) on January 31, 2020 and renewed on April 21, 2020. This guidance applies to the voluntary
reporting of information related to all animal drug shortages, regardless of the drug’s status as a
medically necessary veterinary product (MNVP). 3

1.

Why should animal drug shortages be reported to FDA?
Although reporting animal drug shortages to FDA is voluntary, receiving information about
shortages allows FDA to communicate with sponsors in a timely fashion and take steps where
possible to help avoid or mitigate a shortage.

1

Secretary of Health and Human Services Alex M. Azar, Determination that a Public Health Emergency Exists. (Jan.
31, 2020), renewed April 21, 2020, available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019nCoV.aspx.
2

Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak
(Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-nationalemergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
3

A Medically Necessary Veterinary Product (MNVP) is a product that: (1) is used to treat or prevent a serious animal
disease or condition or is needed to ensure the availability of safe food products of animal origin, and (2) no other
available source of that product or adequate alternative drug substitute exists. Owner inconvenience and nontherapeutic uses are inappropriate reasons for classifying a product as an MNVP. See CVM Program Policy and
Procedures Manual 1240.4170 CVM Medically Necessary Veterinary Drug Product Shortage Management
(https://www.fda.gov/media/70186/download).

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2.

Who should report animal drug shortages to FDA?
Given that animal drug sponsors are most familiar with the supply chain affecting the
manufacture, distribution, and sale of their animal drug products, FDA believes that animal
drug sponsors are in the best position to analyze shortage situations related to their specific
products. Information that is submitted to FDA will not be disclosed except in accordance
with applicable disclosure law, which includes restrictions on the release of confidential
commercial information and trade secrets.

3.

How and when should an animal drug shortage be reported?
Sponsors should submit relevant information to AnimalDrugShortages@fda.hhs.gov as soon
as they become aware of an animal drug shortage.

4.

What information should be included in the report?
Information should include:
• Information regarding the root cause of shortage, e.g., delay in API delivery, shortage of
inactive ingredients or components of containers and closures, delayed inspection,
manufacturing issues.
• Timing of shortage, e.g., when inventories are expected to be depleted, when finished
product will be unavailable for the U.S. market.
• Planned resolution for avoiding or mitigating a shortage, e.g., identification of an alternate
manufacturing site for finished products, API, or other components of the supply chain.
• Any other information that may be relevant to the shortage.

5.

What information should a sponsor provide to support the acceptability
of a CMC supplement or a CMC technical section for an alternate
manufacturer or a new manufacturing facility proposed to prevent or
mitigate a shortage?
The situation may arise where, in order to prevent or mitigate a drug shortage, an animal drug
sponsor may need to utilize an alternate manufacturer or a new manufacturing facility for
their drug product. These types of changes must be the subject of an approved supplemental
application (21 CFR 514.8(b)(2)). In order to avoid approval delays for chemistry,
manufacturing, and controls (CMC) supplements or delays in completing CMC technical
sections due to Good Manufacturing Practice (GMP) status or anticipated difficulty obtaining
pre-approval inspection coverage resulting from FDA’s current inspectional limitations due to
COVID-19, sponsors are encouraged to submit information such as:
• recent foreign regulatory GMP inspection reports (translated to English) for the alternate
or new manufacturing facility
• alternative interim proposals including but not limited to:
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o

enhanced sampling/testing strategies,

o

additional facility manufacturing information,

o

other regulatory commitments

This information, if provided, may be considered as part of CVM’s overall evaluation related
to a reported shortage in order to support continuity in manufacturing and an adequate supply
of animal drug products. For CVM to consider information from foreign regulatory
authorities to support the approval of an application or supplement, the information must be
submitted with an English translation (as described in 21 CFR 514.1(a)).

6.

What information should a sponsor provide to support the acceptability
of other types of manufacturing changes to prevent or mitigate a
product shortage?
CVM will address these types of changes on a case-by-case basis. In general, the sponsor
should provide any available information to ensure the safety, effectiveness, and quality of
the animal drug.

7.

What are examples of steps FDA may take to prevent or mitigate a
shortage?
•

CVM will work closely with the sponsor to assess the root cause of a shortage and
determine possible actions that could help prevent or mitigate the shortage.

•

CVM may advise sponsors on the best filing strategy for a regulatory submission intended
to alleviate the shortage (e.g., submitting information as a Changes Being Effected
supplement versus a Prior Approval Supplement) and the specific information that should
be submitted to CVM. (See 21 CFR 514.8)

•

For an animal drug product in shortage that is determined to be an MNVP, CVM intends
to prioritize and expedite the review of any submissions needed to prevent or mitigate the
shortage.

IV. References
Animal Drug Shortage webpage: https://www.fda.gov/animal-veterinary/product-safetyinformation/animal-drug-shortage-information.

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