Office-use compounding in Maryland

What the rule requires in practice

Each item carries a confidence level. Verbatim rule text is high confidence; a reading of how two provisions interact, or a source that could not be re-verified, is not.

What the permission actually coversHigh confidence

Two drug classes and six named conditions, and nothing outside them. Compounded antibiotics for the emergency treatment of bacterial endophthalmitis or viral retinitis; and compounded antivascular endothelial growth factor agents for the emergency treatment of neovascular glaucoma, wet macular degeneration, or macular edema. The recipient must be an ophthalmologist. Every limb is cumulative.A closed list is more useful to a reader than a bare "no", because the reader can check whether their own preparation is on it. It is not, for anything in this vertical.

A back-reporting duty, and it runs to the pharmacyHigh confidence

Subparagraph (ii) obliges the pharmacy to require the ophthalmologist to inform it of the identity of any patient to whom the drugs are administered. Maryland permits the supply to go out without a patient name and then requires the name to come back — which is a different design from every other permission in this file, and it means the pharmacy carries an ongoing obligation after the shipment leaves.

The second gate, and it is a credential gate rather than a federal conduitHigh confidence

COMAR 10.34.19.19 opens "Unless otherwise authorized" and then requires a person preparing and distributing sterile compounded medications for office use into, out of, or within Maryland to hold a manufacturer’s permit or another permit designated by the U.S. Food and Drug Administration, plus a wholesale distributor’s permit where applicable. A pharmacy holding only a Maryland pharmacy permit holds neither.Those opening two words are the hinge. They are what allows § 12-403(c)(22) and the veterinary limb to operate as exceptions to this regulation. Quoting Reg .19 without them converts a conditional rule into an absolute one, and that misreading has already been made once in this project’s own research.

Two further closures make non-patient-specific sterile supply structurally hardHigh confidence

COMAR 10.34.19.06B requires the dispensed container to bear "The name of the patient". COMAR 10.34.19.08 permits batch preparation only where it is supported by prior valid prescriptions or physician orders, with a documented prescription history on file. Both presume an identified patient before the preparation exists.

The definitions are prescription-terminalHigh confidence

Section 12-101(f)(1) defines compounding as preparation "as the result of a practitioner’s prescription drug order or initiative based on the practitioner/patient/pharmacist relationship", and § 12-101(q) defines a nonresident pharmacy as one shipping "pursuant to a prescription". Maryland reaches the same place as the federal statute through its own definitions rather than by deferring to it.

The veterinary limb, and the only quantity cap Maryland hasHigh confidence

Section 12-403(c)(23) with § 12-510 permits non-patient-specific supply to veterinarians, subject to the USP standards the chapter incorporates, a four-element label — name and strength or active ingredients, beyond-use date, quantity, and the pharmacy’s licence number — federal compliance, and a ceiling of not more than 10% of the pharmacy’s total annual dosage units sold or dispensed. A nonresident pharmacy is measured on its total business within the state.Downstream, Md. Code, Agric. § 2-313(c) confines the veterinarian to a seven-day supply, non-farm animals only, and only where timely access to a compounding pharmacy is unavailable and the preparations are not otherwise commercially available.

No office-use label legend existsHigh confidence

Searched negative across the whole of Health Occupations Title 12 and a rebuilt corpus of every COMAR 10.34 chapter plus 10.13 and 10.19. Maryland prescribes no "office use only" or "not for resale" wording. What it prescribes instead, for sterile containers, is the patient’s name.

The 5% clause — Maryland has both halves and they are not joinedHigh confidence

Section 12-6C-01(u)(2)(vi) excludes from wholesale distribution "the sale of minimal quantities of prescription drugs by retail pharmacies to licensed health care practitioners for office use", with no percentage attached and "minimal" undefined. Section 12-6C-01(v)(2)(xii) separately makes a pharmacy a wholesale distributor where that business exceeds 5% of its annual sales. Both are exemptions from, or triggers for, distributor licensure. Neither says who may compound, or what, or without what.Maryland is unusually strong on this point: § 12-406(b)(3) allows a retail pharmacy to conduct wholesale distribution only with another pharmacy permit holder or a wholesale distributor — a practitioner is not on the list at all. The two provisions are only coherent together if minimal-quantity office-use sales sit outside "wholesale distribution" entirely and never touch the ceiling. The statute never says that; it is an inference from two texts, and no board interpretation resolves it.

Entity or person — split, and both halves are realHigh confidence

"Person" is entity-inclusive in both codes, and entity-capable credentials exist: the pharmacy permit, the wholesale distributor permit, and the controlled-substance establishment registration, whose classification list includes a clinic class. But the dispensing authority attaches to a named individual — § 12-102(a)(4) defines "personally preparing and dispensing" to require the licensee to be physically present where the prescription is filled and to perform a final check, and the physician dispensing permit is non-transferable.A structural point worth keeping: § 12-102 says the title "does not prohibit" a named licensee from doing various things, which is a conduct carve-out for an individual. It uses the true scope exemption — the title "does not apply" — in one subsection only, and that one covers non-drug devices, medical oxygen, durable medical equipment and prosthetics. There is no entity-level exemption from the Maryland Pharmacy Act for prescription drugs.

Last change, and a dated item that could move this pageHigh confidence

A rewrite of COMAR 10.34 chapter 19 — the chapter that contains Reg .19 "Office Use" itself — was proposed on 14 November 2025 and is still unadopted. Under Md. Code, State Gov’t § 10-116(b)(1) a proposal lapses by operation of law if it is not adopted within a year, so on or about 14 November 2026 it is either in force or gone. Separately, 2026 Ch. 206 takes effect 1 October 2026 and amends §§ 12-101 and 12-102, two of the definitional sections this analysis rests on.We do not know the content of the proposed rewrite — see the caveats. It is the single dated item most likely to change Maryland’s answer, and it is the reason this page should be re-read in November 2026 whatever happens between now and then.

Maryland at a glance

Receiving 503B office stock in Maryland

Maryland has no outsourcing-facility licence category at all, and the operational answer is not "nothing to obtain" — it is on the Board of Pharmacy’s own forms, which route these facilities onto the manufacturer application. That route has a textual problem the Board has not addressed, so treat it as a question to ask rather than an answer to rely on.

Everything above this heading answers the supply question: may a state-licensed 503A pharmacy ship non-patient-specific stock? This section answers the other half. Registration with FDA under section 503B is a federal exemption from federal law and preempts no state licensing scheme, so it is never the whole answer on its own — a state credential is the norm rather than the exception, it is not always issued by the board of pharmacy, and in some states the category you would search for does not exist. What Maryland asks for is set out below, including where we could not establish it.

What the 503B must hold to ship inMedium confidence

A wholesale distributor permit from the Board of Pharmacy, applied for on the Manufacturer application. The Board’s Wholesale Distributor Application Instructions direct facilities registered with FDA as outsourcing facilities under section 503B to use the manufacturer’s application instead. That abbreviated application carries a $1,750 fee, $3,250 on reinstatement, and requires the facility’s most recent FDA inspection together with documentation of its federal registration. An out-of-state applicant needs accreditation unless it is located in one of the Board’s named reciprocal states. The permit is defined at § 12-6C-01(w) as one to distribute into, out of, or within the state.Flagged rather than settled, and the gap is real. Section 12-6C-03(b)(2)(i) conditions the abbreviated path on prescription drugs "that are approved by the U.S. Food and Drug Administration", and compounded preparations are not approved drugs. The form therefore routes these applicants onto a statutory ramp whose own precondition they cannot satisfy; on the statute’s face they fall under § 12-6C-03(b)(1) and the full permit. Confirm with the Board rather than publishing either reading as the route. Note also that the terms "outsourcing facility", "503B" and the federal section numbers appear nowhere in Health Occupations Title 12 or in the relevant COMAR chapters — the single "503(b)" citation in the title is the Durham-Humphrey prescription-status provision, a different provision one character away.

Does your practice need a permit?Medium confidence

No permit exists to hold office stock, and administering is exempt: § 12-102(e)(1)(i) exempts a physician from the title for administering a prescription drug or device in the course of treating a patient, with "administering" defined at (e)(2) as the direct introduction of a single dosage at a given time. Dispensing is different — a physician who dispenses needs a dispensing permit from the Board of Physicians.Two provisions cut against a permitless practice even so. Section 12-6C-03(f) makes the purchase itself unlawful if the seller is unpermitted. And § 12-6C-09(c)(1)(i) allows a wholesale distributor to deliver only to "the premises listed on the recipient’s license or permit", with (c)(1)(ii) limited to the immediate needs of a particular patient — so a practice holding no licence or permit that lists premises has no clean delivery address. The term "authorized person" is used in § 12-6C-09 and is defined nowhere in the subtitle.

Administer vs dispenseHigh confidence

The whole exemption turns on it. Administering is the direct introduction of a single dosage at a given time and needs nothing. Dispensing requires a Board of Physicians permit, and the authority is personal: COMAR 10.13.01.04 provides that a licensee shall personally prepare and dispense prescription drugs, and the permit is non-transferable.

Scheduled (controlled) stockHigh confidence

Yes, per location, and before the fact. Md. Code, Crim. Law § 5-301(a)(1) requires registration by the Department before a person manufactures, distributes or dispenses a controlled dangerous substance in the state or transports one into the state, and § 5-301(b) requires separate registration for each principal place of business or professional practice. It is administered by the Office of Controlled Substances Administration inside the Department of Health, under COMAR 10.19.03: a three-year term at $120.Note the transport limb — Maryland reaches a shipment coming into the state, not only activity inside it. As elsewhere in this vertical, most compounded office-use preparations are legend drugs rather than scheduled substances, so this sits outside the path unless the shipment contains controlled substances.

How to check a facility’s credential before you order is set out in how to place an office-use order.

What this page does not establish

• The content of the pending COMAR 10.34.19 rewrite is unknown, and it includes Regulation .19 "Office Use" itself. The Division of State Documents publishes only its most recent issues without charge and the web archive was unreachable from this machine, so we cannot tell you whether Maryland is about to tighten, loosen or delete the credential gate this page relies on. It can be resolved by buying the issue from the Division.
• Whether § 12-403(c)(22) and the veterinary limb at (23) reach a nonresident pharmacy is genuinely ambiguous. Section 12-403(g)(1) lists which subsection (c) duties a nonresident pharmacy must meet, and neither (22) nor (23) is on that list. It decides whether an out-of-state pharmacy can use even the ophthalmology limb.
• The route a 503B facility takes to a Maryland permit is stated on a Board form and is in tension with the statute the form points at. It is published here as a question to put to the Board, not as a settled route.
• A sunset provision at Health Occ. § 12-802 would terminate the whole of Title 12, and the regulations adopted under it, in 2030. It comes from the source research and we did not independently re-verify it, so it is recorded here rather than relied on.
• We searched no case law, attorney-general opinions, board newsletters or disciplinary orders for this state, and search engines were unavailable when it was researched. Read nothing into that silence — it means we have not looked, not that nothing is there.