Cosmic Peptides research library

Outsourcing facility

A compounding operation registered with FDA under section 503B, held to current good manufacturing practice and inspected by FDA on a risk-based schedule.

Last reviewed · Editorial policy

Section 503B lets a facility register with FDA as an outsourcing facility and compound under the direct supervision of a licensed pharmacist. Its drugs are exempt from FDA approval and from the labeling requirement for adequate directions for use, but not from current good manufacturing practice, and FDA inspects outsourcing facilities on a risk-based schedule.

An outsourcing facility may compound from a bulk substance only if it is on FDA's list of substances for which there is a clinical need, or if the drug is in shortage. FDA keeps a separate set of interim categories for 503B; GHRP-2, GHRP-6 and ipamorelin acetate are in its Category 2. The HHS peptide notice of October 2026 covers section 503A only.

See also

Cite this page

Text

Cosmic Peptides. (2026, November 10). Outsourcing facility: glossary entry. Cosmic Peptides Research Library. Retrieved November 10, 2026, from https://cosmicpeptides.com/research/glossary/outsourcing-facility

BibTeX

@misc{cosmicpeptides_research_glossary_outsourcing_facility,
  author       = {{Cosmic Peptides}},
  title        = {Outsourcing facility: glossary entry},
  howpublished = {Cosmic Peptides Research Library},
  year         = {2026},
  month        = nov,
  url          = {https://cosmicpeptides.com/research/glossary/outsourcing-facility},
  urldate      = {2026-11-10},
  note         = {Last reviewed 2026-11-10}
}

RIS

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AU  - Cosmic Peptides
TI  - Outsourcing facility: glossary entry
T2  - Cosmic Peptides Research Library
PB  - Cosmic Peptides
PY  - 2026
DA  - 2026/11/10
UR  - https://cosmicpeptides.com/research/glossary/outsourcing-facility
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.