Glossary

Compounding glossary: the terms a prescriber is expected to already know

USPeptideRx EditorialLast reviewed: August 29, 2026

Almost every term on this page is decided by a body other than the one whose name is on it. USP writes the compounding chapters and enforces none of them — a chapter binds a pharmacy only once a state board adopts a named version by rule, or an accreditor makes it contractual. An FDA registration under section 503B is an exemption from federal requirements and is not permission to ship into any particular state. A state permission to send stock to a prescriber's office does nothing about the federal condition in section 503A. Each entry below gives the term in the words of the rule that defines it, then names who decides whether it applies to you.

These are the words a prescriber meets in the first ten minutes of trying to buy something, usually in a compressed form — “we’re compliant,” “we’re registered,” “your state allows it” — that has nothing in it to check. Each entry is short on purpose: the definition, the rule text behind it, and a link to whichever page argues the point out at length.

The two federal pathways

Which section of the federal statute a supplier is operating under, and what each one costs it.

The two federal pathways: each term defined in one sentence, with the body that decides whether it applies. Reviewed 2026-08-29.
Term	What it means	Who decides whether it applies
503A pharmacy	A state-licensed pharmacy compounding under the conditional federal exemption at 21 U.S.C. § 353a — a condition on the preparation, not a licence class.	A state board of pharmacy licenses it; § 353a decides whether the exemption reaches a given preparation
503B outsourcing facility	A facility that has elected to register with FDA under 21 U.S.C. § 353b; it is subject to cGMP and may supply stock that names no patient.	FDA registration under § 353b, plus the destination state’s own credential
cGMP	FDA’s manufacturing regime at 21 CFR parts 210 and 211, enforced by FDA inspection. A registered outsourcing facility is subject to it. Compounding under section 503A is exempt.	FDA, by regulation and by its own inspections

What authorises an order

The conditions attached to compounding a preparation and to sending it somewhere. Most of the confusion in this subject lives here.

What authorises an order: each term defined in one sentence, with the body that decides whether it applies. Reviewed 2026-08-29.
Term	What it means	Who decides whether it applies
Anticipatory compounding	Preparing a limited quantity before a valid prescription order arrives, on an established history of receiving such orders.	21 U.S.C. § 353a(a)(2), with each state board setting the labelling and record conditions
Essentially a copy	A compounded product that duplicates a marketed one — same active ingredient at a similar strength, usable by the same route — which federal law restricts compounding of.	FDA applies the test; the exception runs through a documented prescriber determination
Office use	A practitioner administering a compounded drug to a patient in their own office, from stock the pharmacy supplied without a named patient.	The state board of pharmacy, and separately the federal exemption at 21 U.S.C. § 353a
Patient-specific prescription	A valid prescription order for one identified individual patient — the condition the federal 503A exemption attaches to the act of compounding.	21 U.S.C. § 353a, restated as a default by state pharmacy rules

Credentials on the receiving side

What the supplier must hold in your state, and what your own practice must hold to take delivery.

Credentials on the receiving side: each term defined in one sentence, with the body that decides whether it applies. Reviewed 2026-08-29.
Term	What it means	Who decides whether it applies
Non-resident pharmacy licence	The credential a state requires of a pharmacy or outsourcing facility located elsewhere before it may ship prescription drugs to recipients in that state.	The destination state — sometimes through an agency other than its board of pharmacy
Terminal distributor of dangerous drugs (TDDD)	Ohio’s licence for a business entity to purchase, possess, administer or distribute dangerous drugs at one named location — prescriber practices included.	The Ohio Board of Pharmacy; other states impose their own analogues, or none

Quality standards and dating

The chapters a pharmacy is judged by, and the date they put on the label. Set side by side because all four get quoted as if they answered the same question.

Quality standards and dating: what each term governs, who it protects, and the status its issuing body gives it. Reviewed 2026-08-29.
Term	The question it answers	Who or what it protects	Status, in the issuing body’s words
Beyond-use date (BUD)	Until when may a compounded preparation be used?	The patient who receives the preparation	Defined by state rule; the compendial dating tables are behind USP’s paywall and are not reproduced here
USP <795>	Was the non-sterile preparation made to a quality standard?	The preparation	Official 1 November 2023
USP <797>	Was the sterile preparation made in an environment that keeps it sterile, and how long is it good for?	The preparation	Official 1 November 2023
USP <800>	Are the people handling hazardous drugs protected from exposure?	Personnel, patients and the environment — not the preparation	Official 1 December 2019; compendially applicable 1 November 2023

Why the last column is the one to read

Every page in this glossary answers the same underlying question somewhere different: who actually makes this apply to the supplier I am about to order from? On the quality side the answer is never USP — it is a state board of pharmacy that adopted a named version by rule, or an accreditor whose standards reference the chapter, or, at the ingredient level only, federal statute. On the pathway side it is never FDA alone, because section 353b exempts a facility from certain federal requirements and preempts no state licensing scheme at all.

That is why a claim needs a chapter number and a state before it means anything, why an adoption date belongs to the state’s rule rather than to USP, and why a supplier who is entirely in order federally can still be unlicensed where you practise. Two pharmacies can be equally diligent and be working to different editions of the same chapter.

None of it is FDA approval. Compounded drugs are not FDA-approved, and a process standard adopted by a state is a different kind of thing entirely. Which federal pathway a supplier sits on is worked out in 503A vs 503B, the vetting sequence in how to vet a compounding pharmacy, and the practical order in how to place an office-use order.

What this page does not establish

The USP chapter texts are behind USP’s subscription paywall and were not retrieved. Everything quoted across this family comes from a public page — USP’s own summaries, a state rule, board guidance, FDA, or an accreditor — and is cited to where it was found.
No beyond-use dating table, day count or hour count appears anywhere in this family, because none could be read from a public source. That is the single highest fabrication risk in this subject.
State examples come from the states with a completed primary-source briefing on this site. There is no fifty-state matrix here, and a state not named is unknown rather than permissive or prohibitive.
Definitions here are drawn from the rule or agency document that supplies them, which means several are the wording of one particular state rather than a national definition. Each entry names whose words it is quoting.
Nothing in this family states or implies the compliance status of any particular pharmacy or facility, including ours.

Sources

Primary sources, fetched directly from the issuing body. No secondary summaries.