US21 CFR21 CFR Part 216Secondary legislationIn force

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This regulation establishes FDA rules for human drug compounding under 21 CFR Part 216. It lists bulk drug substances approved for compounding (including Brilliant Blue G and several topical agents), identifies substances excluded from compounding (Oxitriptan, Piracetam, Silver Protein Mild, Tranilast), and sets FDA evaluation criteria based on physical/chemical characterization, safety, efficacy evidence, and historical use. Compounders cannot claim FDA approval for products made with listed substances.

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PART 216—HUMAN DRUG COMPOUNDING

Subpart A—General Provisions [Reserved]

Subpart B—Compounded Drug Products

§ 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.

(a) The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.

(1) Brilliant Blue G, also known as Coomassie Brilliant Blue G-250.

(2) Cantharidin (for topical use only).

(3) Diphenylcyclopropenone (for topical use only).

(4) N-acetyl-D-glucosamine (for topical use only).

(5) Squaric acid dibutyl ester (for topical use only).

(6) Thymol iodide (for topical use only).

(b) After balancing the criteria set forth in paragraph (c) of this section, FDA has determined that the following bulk drug substances will not be included on the list of substances that can be used in compounding set forth in paragraph (a) of this section:

(1) Oxitriptan.

(2) Piracetam.

(3) Silver Protein Mild.

(4) Tranilast.

(c) FDA will use the following criteria in evaluating substances considered for inclusion on the list set forth in paragraph (a) of this section:

(1) The physical and chemical characterization of the substance;

(2) Any safety issues raised by the use of the substance in compounded drug products;

(3) The available evidence of the effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and

(4) Historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature.

(d) Based on evidence currently available, there are inadequate data to demonstrate the safety or efficacy of any drug product compounded using any of the drug substances listed in paragraph (a) of this section, or to establish general recognition of the safety or effectiveness of any such drug product. Any person who represents that a compounded drug made with a bulk drug substance that appears on this list is FDA approved, or otherwise endorsed by FDA generally or for a particular indication, will cause the drug to be misbranded under section 502(a) and/or 502(bb) of the Federal Food, Drug, and Cosmetic Act.

§ 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act:

Source

https://www.ecfr.gov/current/title-21/part-216

Canonical document at the regulator. Always cite this URL — not the Vantage detail page — in compliance evidence.

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