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APhA submits compounding comments to FDA

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Comments addressed office use, radiopharmaceuticals, hospital compounding

In June 2017, APhA provided comments to FDA at three Listening Sessions on compounding.

Pharmacy organizations. APhA reiterated our support for recent legislation signed into law providing funding for the federal government that called for FDA to issue a memorandum of understanding (MOU) that addresses the “distribution” of compounded products over state lines; final guidance to allow pharmacists to compound for “office use” “in anticipation of receiving patient-specific prescriptions at a later time;” and a reminder to FDA that pharmacies that compound under 503A are under the purview of state boards of pharmacy and are not to be held to current Good Manufacturing Practices (cGMPs).

FDA responded that it still planned to continue to include “dispense” in the definition of “distribute” in a new MOU, and that it believes the agency aligned with congressional intent by issuing final 503A guidance prohibiting office use, despite existing federal law and congressional correspondence allowing the practice.

FDA also stated that it would only take one medication without a prescription during an inspection at a pharmacy compounding under 503A for inspectors to cite cGMPs on a Form FDA-483. APhA will continue to follow up with FDA, the new commissioner, and Members of Congress to construct a framework in accordance with current statutory authority and congressional intent that ensures patients have access to safe and effective compounded medications.

Radiopharmaceuticals. APhA expressed appreciation to FDA and requested final guidance with clarifications requested by our nuclear pharmacist members for the terms “preparation” and “compounding with minor deviations.” FDA also indicated that it would address our members’ concerns that the draft “Insanitary Conditions” guidance requiring unidirectional air and limiting quick movements would prevent the preparation and handling of radiopharmaceuticals.

Hospital organizations. APhA submitted comments at an FDA listening session on its recent Hospital and Health System Compounding draft guidance that allows compounding without a patient-specific prescription to an owned-facility within a 1-mile radius of its compounding pharmacy.

While the 1-mile flexibility helps negate many scenarios which would hurt patient access to needed compounded medications in hospitals and health systems, APhA heard from members that limiting this hospital and health system exception to distribution within a 1-mile radius is still problematic for health systems that have specialty care units outside of the 1-mile radius of the health system pharmacy.

Additionally, the arbitrary distance limitation could prevent the most qualified pharmacy or pharmacist from providing these medications. APhA recommended that enforcement or the use of enforcement discretion regarding dispensing before the receipt of prescription for an individual identified patient when there is an established relationship should be in line with congressional intent and statutory language allowing the practice (section 503A) and based on the quantity compounded rather than a geographical limitation for certain settings. FDA stated that it will address the concerns expressed during the session regarding the 1-mile exemption in forthcoming final guidance.

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