This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
The announcement of the guidance is published in the Federal Register on January 7, 2025.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2015-D-3517 for “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. ( printed page 1137)
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.
Mariestela Buhay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-7313, Compounding@fda.hhs.gov.
FDA is announcing the availability of a final guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (2024 503A Interim Policy Guidance). This guidance finalizes the draft guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act” issued on December 7, 2023 (88 FR 85296), and replaces the guidance of the same title issued in January 2017 (2017 503A Interim Policy Guidance).
Section 503A of the FD&C Act (21 U.S.C. 353a) sets forth the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act: (1) section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice requirements). One of the conditions that must be met for a compounded drug product to qualify for these exemptions is that a licensed pharmacist or licensed physician compounds the drug product using bulk drug substances that (1) comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapters on pharmacy compounding; (2) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary of the Department of Health and Human Services (Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary under subsection (c) of section 503A of the FD&C Act (the 503A bulks list). (See section 503A(b)(1)(A)(i) of the FD&C Act.)
FDA is developing the 503A bulks list, and this guidance describes FDA's interim policy for licensed pharmacists in State-licensed pharmacies and Federal facilities and for licensed physicians who compound human drug products using bulk drug substances while the list is being developed. This guidance revises the policy described in FDA's 2017 503A Interim Policy Guidance with respect to categorization of certain substances nominated for inclusion on the 503A bulks list. This guidance ends the categorization of bulk drug substances into Categories 1, 2, or 3 for those bulk drug substances nominated on or after the date of publication of this guidance.
The 2024 503A Interim Policy Guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or physician for compounding drug products using certain bulk drug substances that are not eligible for use in compounding under section 503A of the FD&C Act because they are not the subject of an applicable USP or NF monograph, components of FDA-approved drug products, or on the 503A bulks list at § 216.23(a) (21 CFR 216.23(a)). One of these conditions is that the bulk drug substance appears in Category 1. As described in the guidance, FDA does not intend to categorize bulk drug substances nominated for inclusion on the 503A bulks list on or after the publication date of this guidance. However, FDA intends to consider such substances for inclusion on the 503A bulks list in accordance with the process and criteria established in the FD&C Act and FDA regulations (see section 503A(b)(1)(A) of the FD&C Act and § 216.23(c)). FDA is evaluating bulk drug substances nominated for the 503A bulks list on a rolling basis. Substances that appear in Category 1 (including substances nominated with adequate supporting information prior to the date of publication of this guidance) may continue to be within the scope of the policy that applies to Category 1 substances, as described in this guidance, until FDA promulgates a final rule determining whether they will be placed on the 503A bulks list in accordance with section 503A(b)(1)(A)(i)(III) of the FD&C Act or unless the Agency removes the substances from Category 1 based on, for example, information about safety risks.
Prior to preparing this guidance, FDA considered comments received on the draft guidance. Editorial changes were made to improve clarity, such as updating references to the publication date of this guidance.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current ( printed page 1138) thinking of FDA on “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” 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.
This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Persons with access to the internet may obtain the guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31546 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P