---
kind: "section"
citation: "21 C.F.R. § 216.23"
title: "21"
number: "216.23"
heading: "Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act."
url: "https://uscodex.org/cfr/21/216.23"
---

# §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)](/cfr/21/503A.md?p=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)](#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)](#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)](#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)](#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)](/cfr/21/502.md?p=a) and/or 502(bb) of the Federal Food, Drug, and Cosmetic Act.

## Notes

### Amendments

[84 FR 4710, Feb. 19, 2019]

### Authority

Authority: 21 U.S.C. 351, 352, 353a, 353b, 355, and 371.

### Source

Source: 64 FR 10944, Mar. 8, 1999, unless otherwise noted.

### Amendments

[84 FR 4710, Feb. 19, 2019]