Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #256 entitled "Compounding Animal Drugs from Bulk Drug Substances." This guidance describes FDA's current thinking about compounding animal drugs from bulk drug substances, identifies our enforcement priorities with respect to drugs compounded from bulk drug substances, and describes circumstances under which FDA generally does not intend to take action against veterinarians or pharmacists in either State- licensed pharmacies or Federal facilities, who compound animal drugs from bulk drug substances. We are also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2018-D-4533] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.” This guidance describes FDA's current thinking about compounding animal drugs from bulk drug substances, identifies our enforcement priorities with respect to drugs compounded from bulk drug substances, and describes circumstances under which FDA generally does not intend to take action against veterinarians or pharmacists in either State-licensed pharmacies or Federal facilities, who compound animal drugs from bulk drug substances. We are also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). DATES: The announcement of the guidance is published in the Federal Register on April 14, 2022. Submit written comments (including recommendations) on the collection of information by May 16, 2022. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/​public/​do/​PRAMain . Find this particular information collection by selecting “Currently under…
Other Federal Register documents from the same docket.
Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Extension of Comment Period
Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Reopening of Comment Period
Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability
Citation: 87 FR 22212
