Office-use compounding in Texas

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.

Statutory basisHigh confidence

Tex. Occ. Code § 562.152, titled "Compounding for Office Use". Unchanged since Acts 2005, 79th Leg., Ch. 28 (S.B. 492), effective September 1, 2005.

Rule basisHigh confidence

Both compounding rules carry the grant at subsection (f): 22 TAC § 291.131(f) for non-sterile and § 291.133(f) for sterile. Both open with the same sentence — a pharmacy may dispense and deliver a reasonable quantity of a compounded preparation to a practitioner for office use by the practitioner in accordance with that subsection.

No federal condition in the rulesHigh confidence

A text search of the entire Texas State Board of Pharmacy rules compilation (Chapters 281–315) returns zero occurrences of 503A, 503B, 353a, "outsourcing facilit" or "Federal Food, Drug". Texas does not use that federal taxonomy and attaches no federal-compliance condition to the office-use grant.This is the reason a Texas page has to be written carefully. Texas grants a permission federal law does not, and a state permission does not displace the federal statute. The defensible sentence always names Texas law; the unqualified version is the one that creates exposure.

Out-of-state pharmaciesHigh confidence

The purpose clauses of both rules expressly cover Class E (non-resident, non-sterile) and Class E-S (non-resident, sterile) pharmacies, so a pharmacy outside Texas may ship office-use stock into Texas — but only while holding the corresponding Texas non-resident licence.

Quantity — a three-prong test, no percentageHigh confidence

Tex. Occ. Code § 562.151(3), mirrored at 22 TAC § 291.131(b)(10) and § 291.133(b)(45): the quantity must not exceed what the practitioner anticipates using before the beyond-use date; must be reasonable given the intended use and the nature of the practice; and — for any practitioner and all practitioners as a whole — must not exceed what the pharmacy can compound to USP identity, strength, quality and purity standards.The third prong is an aggregate capacity ceiling measured across every practitioner the pharmacy serves, not a per-account limit. It is the provision a board reaches for against an office-stock programme run at scale, and it is the single most-omitted condition in vendor marketing.

Sterile batch capHigh confidence

22 TAC § 291.133(d)(1)(B) — 250 final yield units for preparations requiring sterility testing, or 1,000 if fully packaged by an automated compounding device.

Controlled substances — a separate 5.0% capHigh confidence

22 TAC § 291.34(h) — a pharmacy distributing controlled substances to practitioners without a distributor registration may not exceed 5.0% of all controlled substances dispensed and distributed in the 12-month registration period.This mirrors the federal DEA rule and applies only to controlled substances. It does not cap dangerous-drug office stock.

Administer-onlyHigh confidence

Explicit, but note where it lives: it is a mandatory term of the mandatory written agreement between pharmacy and practitioner, not a free-standing rule. A clinic may give office stock to a patient in the practice; it may not hand it to the patient to take home and may not resell it. The sole exception is a veterinarian under § 563.054.

Mandatory label legendHigh confidence

"For Institutional or Office Use Only--Not for Resale" — note the double hyphen, which is in the rule text. A preparation distributed to a veterinarian carries a different legend, "Compounded Preparation".Alongside pharmacy name, address and phone; the preparation name and strength or a list of active ingredients and strengths; the pharmacy lot number; the beyond-use date; the quantity in the container; ancillary, storage and hazardous warnings; and device instructions.

RecordkeepingHigh confidence

22 TAC § 291.131(f)(3) and § 291.133(f)(3) — two years, kept separately from prescription records, producible within 72 hours. Failure to produce within 72 hours "constitutes prima facie evidence of failure to keep and maintain records." The audit trail must be queryable by strength and dosage form, ingredient, lot number, practitioner, facility and pharmacy.

Reporting — office use adds a second regulatorHigh confidence

There is no routine office-use reporting to the Board. Reporting is event-driven, and one of the events runs to a different agency: a recall of an office-use preparation must be reported in writing to the Texas Department of State Health Services, Drugs and Medical Devices Group (22 TAC § 291.131(g)(3)(D) and § 291.133(g)(3)(E)) — a notification that patient-specific dispensing does not trigger. For sterile preparations the Board is notified of a recall within 24 hours and of adverse effects immediately (§ 562.156).

Copies of commercially available products — a real asymmetryMedium confidence

The sterile rule (§ 291.133) expressly allows compounding commercially available products "for dispensing to individual patients or for office use," and its essentially-a-copy escape clause expressly contemplates why a preparation for office use is needed. The non-sterile rule (§ 291.131) contains neither; its copies provision is drafted in patient-specific terms only. On the face of the rules, non-sterile office-stock copies of commercially available products are not among the permitted purposes.This is a reading of the rule text. No Board interpretation confirming it was found, and copy should not be built on it without a call to the Board’s rules queue.

Last changeHigh confidence

The sterile rule § 291.133 was amended effective March 1, 2026 — proposed October 3, 2025 (50 TexReg 6416), adopted with changes February 20, 2026 and republished in full. The Board’s own scope description for that amendment includes recall procedure and recordkeeping, two of the office-use compliance obligations. The office-use subsection (f) itself survived structurally intact, verified against the March 1, 2026 compilation. The non-sterile rule § 291.131 was last amended effective June 10, 2024.Anything written before March 1, 2026 about Texas sterile office-use recordkeeping or recall should be re-checked. Commenters on the amendment included pharmaceutical manufacturers, one of which raised concern that certain amendments may conflict with federal law — a signal of how contested the area is.

Texas at a glance

Receiving 503B office stock in Texas

Texas licenses the facility through the Department of State Health Services. The pharmacy board’s rules do not mention outsourcing facilities at all, and none of the Texas 503A office-use apparatus reaches a 503B shipment.

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 Texas asks for is set out below, including where we could not establish it.

What the 503B must hold to ship inHigh confidence

An out-of-state wholesale drug distributor licence from DSHS. Health & Safety Code § 431.402(a): "A person may not engage in wholesale distribution of prescription drugs in this state unless the person holds a wholesale drug distribution license under this subchapter for each place of business", and 25 TAC § 229.424(b)(1) applies it expressly to distribution from outside the state. There is no separate outsourcing-facility licence class — it is a checkbox on DSHS form EF23-13016.The Board of Pharmacy rules master file contains zero occurrences of "503A", "503B", "353a" or "outsourcing facilit". Its "outsourc" hits all concern outsourcing prescription-order processing to a central-fill pharmacy, an unrelated concept that misleads a careless search. An in-state Texas 503B licenses as a manufacturer instead.

Does your practice need a permit?High confidence

None, on two independent grounds. HSC § 483.041(c) provides that the dangerous-drug possession offence does not apply to possession "in the usual course of business or practice" by a practitioner, and 22 TAC § 291.91(4) defines a Class D clinic as a location "other than a physician’s office" — so a physician’s office is definitionally outside the clinic licensing category.

Administer vs dispenseHigh confidence

Texas asks the same record of the practice either way. HSC § 483.024 requires a practitioner to "maintain a record of each acquisition and each disposal of a dangerous drug for two years", and § 483.025 makes those records inspectable at all reasonable hours together with an inventory of stock on hand — regardless of whether the source was a 503A pharmacy or a 503B outsourcing facility.The Texas office-use apparatus in Occ. Code § 562.152 — the written agreement, the "For Institutional or Office Use Only--Not for Resale" legend, the separate distribution records — is imposed on a PHARMACY. A 503B is not a Texas-licensed pharmacy, so none of it attaches and labelling on its shipment is governed by federal § 353b(a)(10) alone. Do not market the route as the same rules with fewer steps.

Scheduled (controlled) stockHigh confidence

The Texas DPS registration is gone. HSC § 481.061 is now captioned "Federal Registration Required", and subsections (c) and (d) were repealed effective 1 September 2016. DEA registration only, with no separate state registration — worth knowing because stale content still tells Texas clinics to obtain a DPS number.

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

• Texas’s official statutes site now renders as a JavaScript application and returned only its app shell, so the statutory text here came from two mirrors — one verified as of May 2025, which predates the 89th Legislature’s September 2025 effective dates, and one 2025 edition that postdates them. The two agree verbatim and § 562.152 was confirmed in both. Have counsel confirm against the official site before relying on it.
• We did not sweep the legislature bill by bill. The finding that no 2025 session law changed §§ 562.151–562.156 rests on unchanged amendment histories in a post-session compilation rather than on a legislative database search.
• Whether a med spa or a telehealth-only practice qualifies as a "practitioner’s office" or a "health care facility or treatment setting" under § 562.151(1) is not established here. For many readers that is the question the whole answer turns on.
• Sections 562.056 and 562.112 (practitioner-patient relationship) are unread and are likely material for telehealth practices. The Class E and E-S operational standards at §§ 291.102 and 291.104 are unread as well.
• Beyond the primary sources cited here, we have not surveyed board newsletters, declaratory statements, enforcement actions, disciplinary orders or coverage of pending bills. Read nothing into that silence — it means we have not looked, not that nothing is there.