Can a state board of pharmacy enforce federal compounding requirements that aren't part of its own state law? And can it treat language in an FDA warning letter as an enforceable standard? Those questions are at the heart of recent APC letters to pharmacy boards in Virginia and North Carolina.
Virginia
APC's latest letter to the Virginia Board of Pharmacy follows our February 19 letter that remains unanswered. Recent Board disciplinary notices appear to impose an “individualized” prescriber-judgment standard for GLP-1 compounding, drawing on language from a September 2026 FDA warning letter — even though the conduct at issue dates back to October 2024. APC questions both the Board's reliance on a standard not established in Virginia law and its apparent retroactive application of language from a subsequent FDA warning letter.
North Carolina
APC also wrote to the North Carolina Board of Pharmacy this week about its refusal to approve certain pharmacy permit and ownership-transfer applications based on federal “essentially a copy” requirements. North Carolina has not adopted that standard in state law or regulation. APC challenged the Board's apparent use of nonbinding FDA guidance as an enforceable state requirement and urged it to reconsider those decisions — or pursue formal rulemaking if it intends to establish such a standard.
The larger point: APC supports appropriate enforcement to protect patients. But a federal warning letter isn't state law, and nonbinding FDA guidance doesn't automatically become an enforceable state requirement. Pharmacies deserve to know the rules they're expected to follow — and regulators should be held to those rules, too.