80 FR 49247 - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 158 (August 17, 2015)

The Food and Drug Administration (FDA) is extending the comment period for the document that appeared in the Federal Register of May 19, 2015. In the document, FDA requested comments on draft guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49247-49248]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1176]


Compounding Animal Drugs From Bulk Drug Substances; Draft 
Guidance for Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the document that appeared in the Federal Register 
of May 19, 2015. In the document, FDA requested comments on draft 
guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs 
from Bulk Drug Substances.'' FDA is taking this action in response to a 
request for an extension to allow interested persons additional time to 
submit comments.

DATES: FDA is extending the comment period on the document published 
May 19, 2015 (80 FR 28624). Submit either electronic or written 
comments on the draft guidance by November 16, 2015.

ADDRESSES: You may submit comments by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written comments in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-1176. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Division of Compliance, Center for 
Veterinary Medicine, Food and Drug Administration (HFV-230), 7519 
Standish Pl., Rockville, MD 20855, 240-402-7001, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 19, 2015, FDA published a document 
with a 90-day comment period for draft GFI #230 entitled ``Compounding 
Animal Drugs from Bulk Drug Substances.'' The draft guidance describes 
FDA's policies with regard to compounding animal drugs from bulk drug 
substances. When final, the guidance will reflect FDA's current 
thinking on the issues addressed by the guidance.
    FDA has received a request for a 90-day extension of the comment 
period. The request conveyed concern that the current 90-day comment 
period does not allow sufficient time to respond. FDA has considered 
the request and is extending the comment period for 90 days, until 
November 16, 2015. FDA believes that a 90-day extension allows adequate 
time for interested persons to submit comments without significantly 
delaying further FDA action on this guidance document.

II. Specific Topics for Comment

    In addition to comments on the draft guidance as written, we are 
specifically requesting comments on the following issues:
     Should the final guidance address the issue of FDA-
approved animal and human drugs that are in shortage or are otherwise 
unavailable (e.g., disruptions in the manufacture or supply chain; 
business decisions to stop marketing the drug; drug is subject to 
Agency action based on safety, effectiveness, or manufacturing 
concerns)? If so:
    [cir] How should these situations be addressed in the final 
guidance?
    [cir] How should the final guidance define the terms ``shortage'' 
and ``unavailable''?
    [cir] What criteria should FDA use to determine if an approved 
animal or human drug is in shortage or otherwise unavailable?
     Do United States Pharmacopeia and National Formulary (USP-
NF) \1\ chapters 795 and 797 provide suitable standards for animal 
drugs compounded by veterinarians, and if not, what standards of 
safety, purity, and quality should apply to animal drugs compounded by 
veterinarians?
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    \1\ Chapters <795> ``Pharmaceutical Compounding--Nonsterile 
Preparations'' and <797> ``Pharmaceutical Compounding--Sterile 
Preparations'' can be found in both the USP Compounding Compendium 
and the combined United States Pharmacopeia and National Formulary 
(USP-NF). These compendia are available at http://www.usp.org/.
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     Should licensed veterinarians be able to sell or transfer 
an animal drug compounded from bulk drug substances by a State-licensed 
pharmacy or an outsourcing facility to owners or caretakers of animals 
under the veterinarian's care?
     Should the final guidance include a condition on the 
amount or percentage of compounded animal drugs that a pharmacy or 
outsourcing facility can ship in interstate commerce? If so, what would 
a reasonable amount be?
     Is additional guidance needed to address the repackaging 
of drugs for animal use?
    [cir] How widespread is the practice of repackaging drugs for 
animal use?
    [cir] What types of drugs are repackaged for animal use, and why 
are they repackaged?
    [cir] Have problems been identified with repackaged drugs for 
animal use?
     Is additional guidance needed to address the compounding 
of animal drugs from approved animal or human drugs under section 
512(a)(4) or (a)(5) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360b(a)(4) and (a)(5)) and 21 CFR part 530?
     Is additional guidance needed to address the compounding 
of animal drugs from bulk drug substances for food-producing animals?

[[Page 49248]]

     As one condition under which FDA does not generally intend 
to take action for certain violations of the FD&C Act if this and the 
other conditions are followed, FDA is proposing that State-licensed 
pharmacies and veterinarians report any product defect or serious 
adverse event associated with animal drugs they compound from bulk drug 
substances to FDA within 15 days of becoming aware of the product 
defect or serious adverse event. Outsourcing facilities are required to 
report adverse events associated with the drugs they compound. FDA 
believes it is important to receive this information from State-
licensed pharmacies and veterinarians because there are no other State 
Departments of Health or Federal Agencies (e.g., the Centers for 
Disease Control and Prevention) charged with identifying and tracing 
animal injuries or disease associated with an animal drug compounded by 
these entities. FDA has the following specific questions with respect 
to this proposed condition:
    [cir] How many State-licensed pharmacies and veterinarians compound 
animal drugs from bulk drug substances and would potentially be 
reporting product defects and serious adverse events to FDA?
    [cir] Are State-licensed pharmacies and veterinarians reporting the 
same or similar information to any State regulatory agency (e.g., State 
boards of pharmacy, State boards of veterinary medicine)? If so, how 
many reports on average does each State-licensed pharmacy and 
veterinarian submit to these State agencies each year?
    [cir] For purposes of the guidance, how should FDA define the terms 
``product defect'' and ``serious adverse event?''
    [cir] Can FDA achieve the same objective of identifying and tracing 
the source of injuries or disease associated with an animal drug 
compounded from a bulk drug substance through means other than product 
defect and serious adverse event reporting, and if so, what other 
means? For example, would reports of product defects alone achieve the 
same objective?

III. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm or 
http://www.regulations.gov.

    Dated: August 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20174 Filed 8-14-15; 8:45 am]
 BILLING CODE 4164-01-P