CVM GFI #271 Reporting and Mitigating Animal Drug Shortages

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

#271
Reporting and Mitigating Animal Drug
Shortages
Guidance for Industry
This version of the guidance replaces the version made available May 2020. The recommendations remain
the same.
Submit comments on this guidance at any time. Submit electronic comments to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number FDA-2020-D-1140.
For further information regarding this document, contact AskCVM@fda.hhs.gov.
Additional copies of this guidance document may be requested from the Policy and Regulations Staff
(HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place,
Rockville MD 20855, and may be viewed on the Internet at https://www.fda.gov/animal-veterinary,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
http://www.regulations.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
May 2023

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Table of Contents
I. 	Introduction ................................................................................................................................ 1
II. 	Background ................................................................................................................................. 1
III. 	Discussion .................................................................................................................................... 1
A. Why should animal drug shortages be reported to FDA? ................................................ 2
B. Who should report animal drug shortages to FDA? ......................................................... 2
C. How and when should an animal drug shortage be reported?......................................... 2
D. What information should be included in the report?........................................................ 2
E. What information should a sponsor provide to support a CMC supplement or a
CMC technical section for an alternate manufacturer or a new manufacturing
facility proposed to prevent or mitigate a shortage? ......................................................... 2
F. 	What information should a sponsor provide to support the acceptability of other
types of manufacturing changes to prevent or mitigate a product shortage? ................ 3
G. What are examples of steps FDA may take to prevent or mitigate a shortage? ............. 3
IV. 	References.................................................................................................................................... 3

Contains Nonbinding Recommendations
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Reporting and Mitigating Animal Drug Shortages
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 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
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.
In general, FDA’s guidance documents 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
FDA closely monitors the animal drug supply chain for supply disruptions or shortages in the United
States. Based on the Agency’s experience with implementation and comments received, FDA is
revising the guidance (originally titled, “Reporting and Mitigating Animal Drug Shortages during the
COVID-19 Public Health Emergency” (May 2020)) to clarify that the recommendations continue to
reflect the Agency’s current thinking and 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. Accordingly, this version replaces the May
2020 version of the guidance.
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 of certain drugs.
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).1
1 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 non-therapeutic
uses are inappropriate reasons for classifying a product as an MNVP. See CVM Program Policy and Procedures Manual

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A. 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 work with sponsors in a timely fashion and take steps, where possible,
to help avoid or mitigate a shortage.
B. 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. If FDA determines that a product is in shortage, the Agency
intends to work with manufacturers to confirm the accuracy and appropriateness of information
regarding the shortage before posting publicly on FDA’s website.
C. How and when should an animal drug shortage be reported?
Sponsors should submit relevant information via email to AnimalDrugShortages@fda.hhs.gov
as soon as they become aware of a potential or actual animal drug shortage.
D. What information should be included in the report?
• 	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.
E. What information should a sponsor provide to support 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
1240.4170 CVM Medically Necessary Veterinary Drug Product Shortage Management
(https://www.fda.gov/media/70186/download).

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pre-approval inspection coverage resulting from travel restrictions, 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:
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)).
F. 	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.
G. 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 Shortages webpage: https://www.fda.gov/animal-veterinary/product-safety-
information/animal-drug-shortage-information.