IACP Update on S. 959
Revision to S. 959 Secured by IACP: Expressly permits anticipatory compounding for office use
As a result of our continued discussions with the Senate HELP Committee, IACP has succeeded in securing language which clarifies that anticipatory compounding will be permitted within S. 959 as part of the bill’s overall revision of Section 503A of the Federal Drug and Cosmetic Act (FFDCA).
As Section 503A (a)(2)(A) reads now, compounds drug can only be prepared "by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient." Although never enforced, that language does essentially prohibit anticipatory compounding for preparations that are subsequently dispensed or sold to health practitioners for office-use.
Although earlier versions of S. 959 had different language for anticipatory compounding – one of which made it even more stringent and associated with an individual patient – IACP and the Senate HELP Committee have found common ground with new wording. While S. 959 retains most of the original language of 503A, it now includes an entirely new provision that would - for the very first time - acknowledge and permit anticipatory compounding for office use. Specifically, with respect to a "traditional compounder," the bill provides that "in lieu of the prescription for an identified individual patient... the pharmacy receives a practitioner order." [Page 16, lines 1 - 5].
While that’s a “win” for compounders, there are still so many unworkable provisions within S. 959 that push the scope of federal authority over traditional pharmacy compounding practice well beyond that necessary to prevent a future NECC tragedy. For example, new requirements for office-use prescriptions mean burdensome recordkeeping provisions for pharmacies including a 10% monthly limit, a 14 day “window” in which the pharmacist must obtain the names of specific patients to whom the medication was administered by the ordering office or practitioner, and a 14-day cap on beyond use dating.
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