[ STATE ]
Where a compounding pharmacy is actually regulated: the state board licenses and inspects it, and state adoption is what gives compendial chapters legal force.
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
NORTH AMERICA
State law — fifty of them, plus territories, each with its own pharmacy practice act and its own board of pharmacy. This is a jurisdiction on the axis because it behaves like one: for a compounding pharmacy operating under section 503A of the Federal Food, Drug, and Cosmetic Act, the primary regulator is the state board, not FDA. The federal statute defines the exemption; the state licenses the pharmacy, inspects it and can close it.
Through a pharmacy licence issued by the board of the state where the pharmacy operates, and — the part most often missed — through a separate nonresident or out-of-state licence in each state the pharmacy ships into. Compounding standards enter state law by adoption by reference: USP General Chapters ⟨795⟩ for non-sterile, ⟨797⟩ for sterile and ⟨800⟩ for hazardous drugs became officially enforceable on 1 November 2023, and the large majority of state boards require compliance with ⟨797⟩ or incorporate it into state regulation — but the version adopted and the date enforcement begins vary by state.
WHAT TRANSFERS
Almost nothing, and that is the defining feature. A licence in one state confers no authority in another; shipping compounded preparations across a state line generally requires a nonresident licence from the receiving state, on that state’s conditions. Those conditions commonly include proof the home-state licence is current and in good standing, a designated pharmacist-in-charge and a recent inspection report, and some states require accreditation as well. A pharmacy operating nationally is therefore holding and maintaining dozens of licences, each with its own renewal and its own inspection expectations.
USP enforces nothing. ⟨795⟩, ⟨797⟩ and ⟨800⟩ acquire legal force where a state adopts them by reference, and the version adopted is a state-by-state fact. A pharmacy shipping into several states can be subject to different editions of the same chapter at the same time.
Shipping into a state generally requires that state’s nonresident licence. Common conditions include a current home-state licence in good standing, a named pharmacist-in-charge and a recent inspection report; some states additionally require accreditation. The number of licences scales with the map, not with the volume.
A 503A compounding pharmacy is regulated primarily by its state board under the pharmacy practice act. A 503B outsourcing facility registers with FDA and is subject to federal cGMP. The two are not tiers of the same thing, and a pharmacy cannot drift from one into the other by growing.
The 1 November 2023 official date of the revised chapters is a USP date. When a given state began enforcing them — and which version — is a state determination, and planning a compliance programme against the national date alone will be wrong somewhere.
For a pharmacy operating under FD&C Act section 503A, the primary regulator is the board of pharmacy of the state it operates in, under that state’s pharmacy practice act. FDA’s role is defined by the federal exemption and its limits. A 503B outsourcing facility is a different case: it registers with FDA and is subject to federal cGMP.
Through adoption by reference in state law. The revised chapters became officially enforceable on 1 November 2023, and the large majority of state boards either require compliance with ⟨797⟩ or incorporate it into state regulation — but the version adopted and the enforcement date are state determinations, so they vary.
Generally yes. Shipping compounded preparations into a state usually requires a nonresident or out-of-state pharmacy licence from that state, granted on its conditions. Those commonly include evidence that the home-state licence is current and in good standing, a designated pharmacist-in-charge and a recent inspection report; some states also require accreditation.
Because it behaves like a separate one. The licensing authority, the inspecting body, the enforceable standard and its version are all determined at state level, and a permission in one state confers nothing in the next. Folding it into the federal entry would hide the requirement that most often catches compounders out.
ADOPTED, AT A PINNED VERSION
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about United States (state level): requirements still arrive through the authorities below, and the edition in force is theirs to state.
SPEQ records no harmonizer participation for United States (state level). Requirements here are set by the authorities above rather than arriving through a harmonized guide, so evidence prepared for another market does not transfer on that basis.