For your practice
Compounded medication sourcing for solo practitioners
Buying under your own licence is the one purchasing arrangement several of the states we have read exempt from a facility permit: Florida’s requirement expressly does not reach a purchase by a licensed practitioner under their own licence, and California exempts a physician’s own office. The exemption is structural, so ordinary growth ends it — incorporating, changing the setting, adding a location, or compounding anything in-house. The practitioner’s recordkeeping duty does not end with it.
Why does practice size change the answer?
Not because of volume. Because of whose name is on the purchase.
Several of the permits that govern receiving compounded office stock are keyed to a business entity buying prescription drugs, and they carve out the case where a licensed practitioner buys under their own licence. A solo practice is often the only structure that still sits inside that carve-out — which makes it the cleanest receiving arrangement available, and also the most easily lost, because the ordinary steps a growing practice takes are exactly the ones that end it.
That is the whole subject of this page: what the exemption covers, and what quietly moves you out of it.
What does the exemption actually say?
Florida states it in the clearest terms of the states we have read.
Fla. Stat. § 499.01(1)(r) requires a health care clinic establishment permit "for the purchase of a prescription drug by a place of business at one general physical location that provides health care or veterinary services, which is owned and operated by a business entity that has been issued a federal employer tax identification number." The carve-out then reads, in full: "This paragraph does not apply to the purchase of a prescription drug by a licensed practitioner under his or her license."
California reaches the same result through its definitions rather than through an exception. Bus. & Prof. Code § 4059.5(d) lets a physician’s own office be furnished dangerous drugs without a board licence, while §§ 4180 and 4190 require a board clinic licence for the settings they define — nonprofit and free clinics, surgical clinics, accredited outpatient settings and Medicare-certified ambulatory surgical centres. Texas exempts practitioners from its dangerous-drug possession restrictions, and its pharmacy-class definitions exclude a physician’s office from the clinic class outright.
What ends the exemption?
Four ordinary business events, none of which feels like a regulatory decision at the time.
Incorporating, or letting the entity sign. In Florida the trigger is the purchase being made by the business rather than by the practitioner. The same drugs, the same shelf, a different name on the purchase order, and a permit applies. Changing the setting. In California the exemption attaches to a physician’s office; a surgical clinic or accredited outpatient setting is a different category with its own licence. Compounding anything yourself. Ohio’s guidance for prescriber practices states that in general its licensure exemptions do not apply where the prescriber practice is engaged in drug compounding, and its own caveat is that preparing medications in advance of administration requires licensure and compliance with the Board’s compounding rules. Adding a location. More than one of these permits attaches per physical location rather than per practice.
If any of those is on your roadmap, the question is worth answering before the move rather than after.
What does not go away?
The records, and this is the part most often missed precisely because the permit question was answered favourably.
Texas requires a practitioner to keep records of the acquisition and disposal of dangerous drugs, and that duty attaches whether or not any permit does. It is a practitioner obligation about what came in and what went out, and it exists independently of the pharmacy-side records your supplier keeps about the same shipments.
The general shape holds across the states we read: an exemption from a facility permit is not an exemption from accountability for the stock. A practice that treats a clean permit answer as the end of the analysis is the one that has nothing to show an inspector.
Does your state permit office stock at all?
That is a separate question and it is answered before any of the above matters.
Georgia’s rule prohibits non-patient-specific distribution for office use by a human practitioner in those words, while expressly leaving outsourcing facilities untouched. Illinois permits it for non-sterile preparations only, with a mandatory container legend and five-year records on the pharmacy side. Ohio’s statutory carve-out is real but narrow, requiring that the drug not be commercially available, that only a limited quantity be provided, and that it be an occasional exception to patient-specific dispensing — while a separate Board rule commands compliance with 21 U.S.C. § 353a.
The rule text for each is in the state-by-state office-use guide, and the ordering sequence itself is walked through at how to place an office-use order.
And is your supplier credentialed where you are?
Federal registration is not the end of that question either.
Section 353b is a federal exemption from federal requirements and preempts no state licensing scheme. In every state whose receiving side we have read from primary sources, a facility registered with FDA as an outsourcing facility must also hold that state’s own credential before shipping compounded stock in — and in North Carolina, Texas and Louisiana that credential does not come from the board of pharmacy. Ask for it by name and by issuing agency.
An entity-owned practice faces the mirror image of this page’s question; that version is written for med spas, and the rest are indexed at sourcing by practice type.
What to bring when you apply
Three answers, and the first is the one that decides the other two.
Who buys — your own name and licence, or a business entity with an employer tax identification number. What the setting is, in your state’s own vocabulary, because "office" and "clinic" are categories with consequences rather than descriptions. And whether each item is administered or dispensed, since that line governs a separate set of registrations everywhere we looked.
Because you are buying under your own licence, that licence is the thing a pharmacy verifies, and it is worth knowing what they check and against which register before you send it: prescriber credentialing.
If you want those checked against your state before you commit to anything, you can apply for an account.