Cosmic Peptides research library

503A bulks list

The list, made by FDA regulation, of bulk substances without a monograph or an approved drug that may be used in section 503A compounding.

Last reviewed · Editorial policy

Section 503A lets a pharmacy compound from a bulk substance only if it has a United States Pharmacopeia or National Formulary monograph, is a component of an FDA-approved drug, or appears on this list. FDA builds the list by notice-and-comment rulemaking; its final rule of February 2019 placed six substances on it.

Substances reach the list by nomination. While FDA evaluates them, its interim policy sorts them into categories, and its Pharmacy Compounding Advisory Committee advises on each. A committee recommendation does not add a substance to the list. Only a final rule does.

As of November 2026 no peptide sold for research is on the list. The committee recommended six peptides in July 2026, and HHS has said it will not take enforcement action against compounding them while FDA writes a rule.

See also

Cite this page

Text

Cosmic Peptides. (2026, November 10). 503A bulks list: glossary entry. Cosmic Peptides Research Library. Retrieved November 10, 2026, from https://cosmicpeptides.com/research/glossary/503a-bulks-list

BibTeX

@misc{cosmicpeptides_research_glossary_503a_bulks_list,
  author       = {{Cosmic Peptides}},
  title        = {503A bulks list: glossary entry},
  howpublished = {Cosmic Peptides Research Library},
  year         = {2026},
  month        = nov,
  url          = {https://cosmicpeptides.com/research/glossary/503a-bulks-list},
  urldate      = {2026-11-10},
  note         = {Last reviewed 2026-11-10}
}

RIS

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AU  - Cosmic Peptides
TI  - 503A bulks list: glossary entry
T2  - Cosmic Peptides Research Library
PB  - Cosmic Peptides
PY  - 2026
DA  - 2026/11/10
UR  - https://cosmicpeptides.com/research/glossary/503a-bulks-list
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.