Compliance · State rules

Office-use compounding in North Dakota

Permitted by rule, but only from an outsourcing facility or a resident North Dakota pharmacy

USPeptideRx EditorialLast reviewed: August 31, 2026

North Dakota answers this question by name, in the affirmative, under a rule heading that is the question: "Compounding for office use". Almost nowhere else in this file does a state do that. The permission is real and it is narrow in one specific way — it names who may supply the stock. A preparation may reach a North Dakota practitioner’s office only from a facility licensed as an outsourcing facility under North Dakota law, or from a resident North Dakota pharmacy. An out-of-state 503A pharmacy is neither, and the next subsection calls sales to other clinics manufacturing that is not allowed. So the useful sentence about North Dakota is never "office use is permitted" on its own; it is "permitted, and here are the only two lawful suppliers."

The governing rule

North Dakota’s office-use position is set by N.D. Admin. Code § 61-02-01-03(9). The text below is quoted verbatim; everything outside a quote block is our summary of it, and the two are kept visually separate on purpose.

N.D. Admin. Code § 61-02-01-03(9)(a) — the permission, in full, under the heading "Compounding for office use"

It is acceptable to compound human drug products to be used by North Dakota practitioners in their office for administration to patients provided they are prepared by a facility licensed as an outsourcing facility in accordance to North Dakota Century Code section 43-15.3-13 or by a resident North Dakota pharmacy. It is acceptable for a North Dakota licensed pharmacy to obtain a compounded human drug from a licensed outsourcing facility and dispense it to a patient.

N.D. Admin. Code § 61-02-01-03(9)(b) — the veterinary subsection, which drops the residency requirement

It is acceptable for any licensed pharmacy to compound veterinary drug products to be used by veterinarians in their office for administration to client’s animals. These compounded office use products may be dispensed to clients for use in a single treatment episode, not to exceed a one hundred twenty-hour supply.

N.D. Admin. Code § 61-02-01-03(9)(c) — what happens outside the two permitted suppliers

Sales to other pharmacies, veterinarians, clinics, or hospitals are manufacturing and are not allowed. It is the responsibility of the pharmacy and pharmacist involved in the compounding to ensure compliance with this section for the products they compound.

N.D.C.C. § 43-15.3-01(28)(h) — a separate wholesale exclusion that is not a second supply route

The sale of minimal quantities of prescription drugs, medical gases, or medical equipment by retail pharmacies to licensed practitioners for office use.

North Dakota State Board of Pharmacy, minutes of 20 March 2025 — the Columbine Drug settlement

They have shipped compounded drugs into North Dakota, for the use by a physical therapist, without having a North Dakota Pharmacy License.

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.

The rule is captioned for the questionHigh confidence: Subsection (9) of the pharmacy-practice rule is headed "Compounding for office use". Most states in this file answer the question sideways — through a prescription requirement, a definition, or a wholesale exemption that happens to exclude it. North Dakota wrote a provision about the thing itself and answered it in the affirmative, which makes it unusually safe to rely on and unusually hard to misread.
The condition is on the supplier, and the word doing the work is "resident"High confidence: The permission runs only to preparations made by an outsourcing facility licensed under N.D.C.C. § 43-15.3-13, or by a resident North Dakota pharmacy. Residency is not decoration: the very next subsection grants the veterinary version to "any licensed pharmacy", with the residency words absent. Both subsections were written into one section at one time, so the difference between them is a drafting choice rather than an accident.What "resident North Dakota pharmacy" means is not defined in the pharmacy chapter, the wholesale chapter or the rule article. North Dakota does separately define and license a "nonresident pharmacy", so the term is being used against that contrast — but whether a multi-state pharmacy holding a North Dakota licence qualifies is not settled by any text we read, and it is the single most consequential open question on this page.
No quantity cap on human office stockHigh confidence: There is none. The 120-hour limit that appears in this rule is in the veterinary subsection, applies to compounded products dispensed to an animal owner for a single treatment episode, and does not reach human office stock. Anyone quoting a ceiling of that kind for a human practice has carried a veterinary number across a subsection boundary.
Supplying outside the permitted channel is manufacturing, not a practice violationHigh confidence: Subsection (c) does not say office use is prohibited. It says sales to other pharmacies, veterinarians, clinics or hospitals "are manufacturing and are not allowed". That is a reclassification, and it matters because manufacturing carries its own licensure regime rather than a rule-breach finding against a pharmacy licence. The subsection also places the compliance duty on the pharmacy and the pharmacist together.
There is an enforcement action squarely on this questionHigh confidence: At its meeting of 20 March 2025 the Board approved a stipulated settlement with a Colorado pharmacy that had shipped compounded drugs into North Dakota for use by a physical therapist without holding a North Dakota pharmacy licence. It is the clearest illustration in this file of what the residency condition actually does: the question the Board acted on was the supplier’s licence, not the preparation.The minutes record the history and the vote. The stipulation document itself is referenced as an agenda tab and was not published with them, so the terms of the settlement — what was paid, what was admitted — are not established here.
The wholesale exclusion is not a second, unrestricted laneHigh confidence: North Dakota’s wholesale chapter excludes minimal-quantity office-use sales by retail pharmacies from the definition of wholesale distribution. It is tempting to read that as an independent permission running alongside the compounding rule. It is not: it exempts a transaction from wholesale-distributor licensure and says nothing about who may compound the preparation in the first place. A non-resident pharmacy does not acquire the right to supply North Dakota office stock by pointing at it.
Sterile and non-sterile are not splitHigh confidence: The permission reaches "human drug products" without a sterility line, so there is no narrower sterile rule to fall back to and no separate sterile permission to find. The quality standards come in by reference to the USP chapters through the rest of the same rule, which treats hazardous drugs separately.
Last change, and one that is commonly misdatedHigh confidence: The current text has been in force since 1 January 2024. The rule’s own history line runs 1983, 1988, 1999, 2003, 2012, 2017, 2019 and then 2024. Note what that means: North Dakota did not "adopt office use in 2017". A permission already existed, and the 2017 amendment restructured it and added the source restriction that is now its most important feature.

North Dakota at a glance

North Dakota office-use compounding summary, reviewed 2026-08-31
Human office use	Permitted, but only from an outsourcing facility or a resident North Dakota pharmacy
Sterile preparations	No split — the permission reaches human drug products without a sterility line
Quantity cap	None for human office stock; the 120-hour limit is veterinary
Mandatory label legend	Compounder’s label under ch. 61-04-06, plus beyond-use date and lot number
Board reporting	None for office use; 48-hour production duty falls on the outsourcing facility
Last change	Current text effective 1 January 2024
Governing rule	N.D. Admin. Code § 61-02-01-03(9)

Receiving 503B office stock in North Dakota

North Dakota is the state in this file where the receiving question is easiest to answer for the supplier and hardest to answer for the practice. The rule names the supplier’s credential in terms; it says nothing at all about what the receiving office must hold, and that silence is left as silence here rather than filled in by inference.

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

What the 503B must hold to ship inHigh confidence: Registration with the FDA as an outsourcing facility under section 503(b), and a North Dakota licence carrying the outsourcing-facility classification, with a licensed pharmacist in the facility’s state of residence designated as the responsible person on the licence. The fee for that classification is $200. On the Board’s request the facility has 48 hours to produce inspection reports, federal reports of objectionable conditions issued against it, and lists of its distribution of products into the state.The chapter does not require accreditation of any kind — no accreditation programme is named anywhere in it. Any claim that North Dakota conditions the licence on an accreditation is unsupported by the chapter text.
Does your practice need a permit?Low confidence: Not established. The office-use rule is addressed entirely to suppliers and imposes its compliance duty on "the pharmacy and pharmacist involved in the compounding". Nothing we read states what the receiving practice must hold, so the question a North Dakota practice can answer today is whether its supplier is one of the two permitted ones.
Administer vs dispenseHigh confidence: The permission is written for administration: stock compounded to be used by practitioners "in their office for administration to patients". A second, separate sentence handles the dispensing case and routes it through a pharmacy — a North Dakota licensed pharmacy may obtain a compounded human drug from a licensed outsourcing facility and dispense it to a patient. The two are written as different transactions.
Scheduled (controlled) stockHigh confidence: North Dakota requires its own controlled-substance registration, obtained annually from the Board of Pharmacy, with a separate registration at each principal place of business or professional practice. Federal registration does not substitute for it: complying with the federal registration provisions "entitles them to be registered" under the state chapter, which is an entitlement to apply rather than a deemed registration.That sentence is in § 19-03.1-17(4), not in the registration-requirements section next to it. Both agencies here are the same one, which is not true of every state on this site.

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

The federal layer still applies

Whatever North Dakota law allows, federal law applies on top of it and is not satisfied by state permission. 21 U.S.C. § 353a conditions the federal compounding exemptions on a drug being compounded for an identified individual patient on receipt of a valid prescription order. A state rule cannot create a federal safe harbour, and several state rules say so in their own text. The separate federal pathway for non-patient-specific office stock is the 503B outsourcing facility — the differences are set out in 503A vs 503B.

For how North Dakota compares with the other states reviewed, see the state-by-state comparison.

What this page does not establish

The single word this whole page turns on — "resident", in the phrase "a resident North Dakota pharmacy" — is not defined in the pharmacy chapter, in the wholesale chapter, or in the rule article that uses it. North Dakota does define and separately license a "nonresident pharmacy", which is the contrast the term is drawn against, but whether a multi-state pharmacy holding a North Dakota licence counts as resident is not answered by any text we read. A pharmacy in that position should put the question to the Board before relying on either answer.
What the receiving practice itself must hold is beyond the scope of this page. The rule binds suppliers, and nothing we read addresses the practice on the other end of the transaction.
Board minutes were read for 2025 and 2026 and contain no discussion of office use, outsourcing facilities or section 503B beyond the enforcement matter described above; the Board’s newsletters were not readable. The 2023 minutes carrying the adoption vote for the amendment that took effect in January 2024 are outside what we read.
In January 2026 the Board recorded that its members had reviewed this chapter of the rules "for possible revisions and reductions in rules". No motion was made and no section was named, and the subject does not reappear in later minutes. It is noted here as a direction of travel, not as a change.
We searched no case law, attorney-general opinions or declaratory rulings 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.

Sources

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