Peptides: federal overview

Compounded peptides fall under FD&C Act compounding rules.

Tier tags: L1 statute/ordinance, L2 final or temporary rule, L3 official guidance or agency action, L4 pending bill or proposed rule, L5 news or lead (never law).

Federal

• [L1] Federal: Pharmacy compounding: bulk drug substance conditions (relevant to compounded peptides). Quoted: "(b) Compounded drug (1) Licensed pharmacist and licensed physician A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician— (A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations— (i) that— (I) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pha" Source: 21 U.S.C. 353a(b) (FD&C Act § 503A)

Official text (batch 7)

• [L3] Federal: BPC-157 in Category 2 (safety risks). Quoted: "BPC-157 Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization. FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans." Source: FDA, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (agency web page)
• [L3] Federal: 503B interim Category 2 meaning. Quoted: "Category 2 – These substances were nominated with sufficient supporting information to permit FDA to evaluate them, and they may be eligible for inclusion on the 503B bulks list. However, FDA has identified significant safety risks relating to the use of these substances in compounding pending further evaluation and, therefore, does not intend to adopt the policy described for the substances in category 1." Source: FDA, Bulk Drug Substances Used in Compounding Under Section 503B (agency web page)

Browser-read official text (batch 8)

• [L3] Federal: 503A interim Category 1 meaning. Quoted (browser-read, manual check): "Category 1 – These substances may be eligible for inclusion on the 503A bulks list, were nominated with sufficient supporting information for FDA to evaluate them" Source: FDA, Bulk Drug Substances Used in Compounding Under Section 503A (agency web page)

Official text (batch 9)

• [L1] Federal: 503B outsourcing facilities. Quoted: "§353b. Outsourcing facilities (a) In general Sections 352(f)(1), 355, and 360eee–1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met:" Source: 21 U.S.C. § 353b(a) (FDCA § 503B)
• [L3] Federal: Revised 503A bulks interim policy. Quoted: "SUMMARY: 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 hum" Source: 90 FR 1136 (Jan. 7, 2025), FDA guidance notice 2024-31546

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