Cosmic Peptides research library

Compounded drug

The preparation of a drug by a licensed pharmacist or physician for an identified individual, exempt from FDA approval only under the conditions of section 503A or 503B.

Last reviewed · Editorial policy

Section 503A of the Federal Food, Drug, and Cosmetic Act exempts a compounded drug from FDA approval, from the labeling requirement for adequate directions for use and from current good manufacturing practice, but only when it is compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician, on a valid prescription for an identified individual. The bulk substance must have a pharmacopeia monograph, be a component of an approved drug, or appear on the 503A bulks list, and it must come from an FDA-registered establishment with a valid certificate of analysis.

In FDA's words, compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed. A compounded drug that misses any condition of section 503A loses the exemption.

A research chemical is not a compounding ingredient: it does not meet the bulk-substance conditions, and several state boards require every ingredient to come from a source they permit.

See also

Cite this page

Text

Cosmic Peptides. (2026, November 10). Compounded drug: glossary entry. Cosmic Peptides Research Library. Retrieved November 10, 2026, from https://cosmicpeptides.com/research/glossary/pharmacy-compounding

BibTeX

@misc{cosmicpeptides_research_glossary_pharmacy_compounding,
  author       = {{Cosmic Peptides}},
  title        = {Compounded drug: glossary entry},
  howpublished = {Cosmic Peptides Research Library},
  year         = {2026},
  month        = nov,
  url          = {https://cosmicpeptides.com/research/glossary/pharmacy-compounding},
  urldate      = {2026-11-10},
  note         = {Last reviewed 2026-11-10}
}

RIS

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TI  - Compounded drug: glossary entry
T2  - Cosmic Peptides Research Library
PB  - Cosmic Peptides
PY  - 2026
DA  - 2026/11/10
UR  - https://cosmicpeptides.com/research/glossary/pharmacy-compounding
Y2  - 2026/11/10
LA  - en
ER  -

Cite the date the page was last reviewed, November 10, 2026, as its version. Reference managers such as Zotero can save this page directly.

Changes to this page

  1. Published Five glossary terms for compounding

    Compounded drug, the 503A bulks list, FDA's interim bulk-substance categories (Category 1, 2 and 3), outsourcing facility and enforcement discretion: the terms the United States series' compounding pages rely on, each linked where it first appears in the library.

Changes of substance are listed here; wording changes are not. Every correction is also on the corrections log.

For in vitro laboratory research only. Not for human or veterinary use. This library describes chemistry, analytical methods and published laboratory research; it gives no guidance on use in people or animals.