Compounding pharmacy, outsourcing facility or research supplier

A 503A pharmacy, a 503B outsourcing facility and a research supplier operate under three different sets of rules. What each one is, why a pharmacy cannot compound BPC-157 today, and why a research vial has no place in the other two chains.

By Touchstone PeptidesSeptember 22, 20268 minute read

Compounded drugs in the United States come from two kinds of source, a 503A pharmacy and a 503B outsourcing facility, and each is defined by a section of the Federal Food, Drug, and Cosmetic Act that says exactly which bulk substances it may use. Research-use-only material is defined by neither section and qualifies for neither. That is why a pharmacy cannot compound BPC-157 today, why a clinic cannot lawfully turn a research vial into something for a person, and why this site sells into only one of the three chains. The statuses below are as of September 21, 2026.

What section 503A is

Section 503A (21 U.S.C. 353a) is the pharmacy chain. It exempts a compounded drug from three requirements that otherwise apply to every drug, new-drug approval, current good manufacturing practice, and labelling with adequate directions for use, but only if the compounding is done for an identified individual on a prescription. The statute's own words:

Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient21 U.S.C. 353a(a)

The compounder must be "a licensed pharmacist in a State licensed pharmacy or a Federal facility" or "a licensed physician." FDA's compounding page summarises the effect: the drugs "must be compounded based on the receipt of valid patient-specific prescriptions," and 503A compounders are not subject to CGMP. State boards of pharmacy license and inspect them.

What section 503B is

Section 503B (21 U.S.C. 353b) created outsourcing facilities in the Drug Quality and Security Act of November 27, 2013, passed after the 2012 fungal meningitis outbreak. An outsourcing facility is a different kind of entity. The statute defines it as a facility that "is engaged in the compounding of sterile drugs," "has elected to register as an outsourcing facility" and "complies with all of the requirements of this section." It "is not required to be a licensed pharmacy" and "may or may not obtain prescriptions for identified individual patients." FDA's page adds that outsourcing facilities "are subject to CGMP requirements," "are inspected by FDA according to a risk-based schedule," and may distribute compounded drugs "either pursuant to a patient-specific prescription or in response to an order from a health care provider." They register with FDA annually and report what they compound twice a year. FDA's registry of them listed 96 facilities when checked on September 21, 2026.

So the two chains differ in who regulates them (state boards versus FDA inspection), what standard they make to (no CGMP versus CGMP), and whether a named person has to exist before the drug is made.

What the bulks lists do, and why they decide the BPC-157 question

Both sections restrict the raw material. A 503A compounder may use a bulk drug substance only if it meets one of three conditions:

(I) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding; (II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or (III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (c)21 U.S.C. 353a(b)(1)(A)(i)

The list in condition (III) is the 503A bulks list. Section 503B has its own list, of substances "for which there is a clinical need," plus an allowance for substances on FDA's drug shortage list. While FDA works through nominations to those lists it runs an interim policy that sorts nominated substances into Category 1, Category 2 and Category 3. What each category means, and the three 2026 events that moved peptides between them, are dated in Category 1, Category 2 and the 503A bulks list.

BPC-157 fails all three conditions: it has no USP or NF monograph, is a component of no approved drug, and is not on the bulks list. Its Category 2 nomination was withdrawn by the nominators, which FDA's page reflected on April 22, 2026, and withdrawal is not a clearance, so as of September 21, 2026 a 503A pharmacy has no lawful pathway to compound it. The same reading applies to the other withdrawn peptides; the dated record is in BPC-157 in 2026.

Sermorelin shows the other side of condition (II). Because Geref was an approved drug (1997, now discontinued), sermorelin acetate is a "component of a drug approved by the Secretary," and FDA's 503B Category 1 list marks it as such. The difference between sermorelin and BPC-157 in a pharmacy is not chemistry. It is that one molecule was once the active ingredient of an approved product and the other never was. The full picture, molecule by molecule, is in the status table.

Where the raw material must come from

The statute also says where a compounder's bulk substance must come from. Under 503A(b)(1)(A)(ii) and (iii) the substances must be "manufactured by an establishment that is registered under section 360 of this title (including a foreign establishment that is registered under section 360(i) of this title)" and "accompanied by valid certificates of analysis for each bulk drug substance." A registered establishment and a lot-specific certificate are the minimum paperwork a pharmacy can accept, and that minimum already excludes an unregistered source with a representative certificate.

What research use only is, and is not

Research-use-only material is supplied for laboratory work. That is the whole of its intended use, and it is described in what research use only actually means. Set against the two compounding chains, the gaps are concrete.

It is not made under CGMP for drugs, and no one certifies that it was.
It is not labelled as a drug. A research label carries identity, quantity and lot; it has no directions, because there are none.
It is not released as sterile. A purity certificate reports chromatographic purity, identity by mass and, on this site, net peptide content. It does not report a USP <71> sterility test unless the certificate says so, and a research vial should be assumed untested for sterility and endotoxin unless the paperwork states otherwise.
It is not a "bulk drug substance" in the statutory sense for a pharmacy, because the seller has not supplied it as one, and under 21 CFR 201.128 a distributor who intends an article for a use its supplier did not takes on the labelling duty for that use. What FDA reads to find that intent is set out in what FDA reads before calling a research product a drug.

This is why the three chains cannot be mixed. A 503A pharmacy that took in a research vial would have material that fails the registered-establishment and certificate conditions and, for most of the peptides people ask about, a substance that is on no list at all. A 503B facility would have the same problem plus a CGMP gap it cannot close after the fact. And a clinic or med-spa is not a compounder of either kind, so it has no exemption to begin with; a research vial in a clinic is an unapproved new drug with a research label on it.

The three chains side by side

	503A pharmacy	503B outsourcing facility	Research-use-only supplier
Defined by	21 U.S.C. 353a	21 U.S.C. 353b	No FDA drug exemption; intended use judged under 21 CFR 201.128
Who oversees	State board of pharmacy	FDA registration and risk-based inspection	Not a drug establishment; FDA acts if the material is marketed as a drug
Manufacturing standard	Exempt from CGMP under 503A	CGMP required	No drug CGMP claimed
Needs a named person first	Yes, a valid prescription	No, may compound to a provider's order	No; there is no person, by definition
Permitted raw material	USP/NF monograph, approved-drug component, or 503A bulks list, from a registered establishment with a COA	503B "clinical need" list or the shortage list	Whatever the seller can document; it is a reagent, not a bulk drug substance
Can it hold BPC-157 today	No pathway	No pathway	As a laboratory reagent only
Output	A drug for one named person	A drug for a provider's stock	A lyophilized reagent with a certificate

This site operates in the third column only: every item in the catalog is a reagent with a lot number and two certificates, and the things we will not sell or say are listed at what we will not sell.

Sources

For laboratory research use only. Not a drug, not a supplement, and nothing here is a claim about what any of this material does in a person or an animal.

Two things before you come in.