FDA issues final 503A compounding guidance prohibiting office use

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APhA opposes final guidance in joint comments

At the end of 2016, FDA issued final guidance that will require pharmacists to obtain a valid “patient-specific prescription” for each drug compounded under Section 503A of the Drug, Quality and Security Act (DQSA), despite existing federal law which states that a licensed pharmacist can compound “in limited quantities before the receipt of a valid prescription order for such individual patient.”

The final guidance states that “anticipatory compounding” by pharmacists under Section 503A can only be done in “limited quantities” of “no more than a 30-day supply … to fill valid prescriptions it has not yet received.” Otherwise, only “outsourcing [503B] facilities can compound and distribute sterile and non-sterile nonpatient-specific drug products to hospitals, clinics, and health care practitioners for office use.” The final guidance also includes a definition of “distribution” that includes “dispensing a drug directly to a patient.”

APhA already has submitted joint comments with other pharmacy organizations and stakeholders to the incoming Trump administration opposing the final guidance and will submit similar comments to the FDA.

The stakeholders wrote in their joint comments: “We ask for your support in encouraging the FDA to cease using un-finalized non-legally binding guidance documents in their enforcement actions as if they have the weight of law or regulation, and in preventing the finalization of any pending draft guidance documents between now and the end of the current administration. Should the FDA move forward with finalizing these guidance documents, we believe the new administration should give consideration to rescinding them and reconsidering the policies contained therein in light of the new administration’s policy priorities.”

If finalized, the FDA guidance is not binding on the FDA or the public; however, it is the FDA's official position and often leads to further federal regulations. 

For more information, e-mail Michael Baxter at mbaxter@aphanet.org.

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