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Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Extension of Comment Period

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.


Notice of availability; extension of comment period.


The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that published in the Federal Register on November 20, 2019. In that notice, FDA requested comments on the draft guidance for industry (GFI) #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.” FDA is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.


FDA is further extending the comment period on the document published November 20, 2019 (84 FR 64085), which was reopened in a document published February 20, 2020 (85 FR 9783). Submit either electronic or written comments on the draft guidance by October 15, 2020, to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance.


You may submit comments on any guidance at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2018-D-4533 for “Compounding Animal Drugs From Bulk Drug Substances.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

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Eric Nelson, Division of Compliance (HFV-230), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7001,

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In the Federal Register of November 20, 2019, FDA published a notice announcing the availability of draft GFI #256 entitled “Compounding Animal Drugs From Bulk Drug Substances” with a 90-day comment period. We requested comments on the draft guidance with respect to animal drug compounding from bulk drug substances under certain circumstances when no other medically appropriate treatment option exists.

Interested persons were originally given until February 18, 2020, to comment on the draft guidance. The Agency received requests to allow interested persons additional time to comment. The requests conveyed concern that the initial 90-day comment period did not allow sufficient time to develop a comprehensive response. FDA considered these requests and reopened the comment period for an additional 120 days, until June 17, 2020 (85 FR 9783).

Since then, FDA has received additional requests to further extend the comment period. FDA has considered the requests and is extending the comment period for the notice of availability for another 120 days, until October 15, 2020. The Agency believes that a further extension of 120 days allows adequate time for interested persons to submit comments.

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Dated: June 8, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2020-12750 Filed 6-11-20; 8:45 am]