Advocacy & Practice Updates — Advocacy & Practice

FDA Issues Long-Awaited Final Guidance on Compounding (503A) Pharmacies

The FDA has issued its Final Guidance for the Prescription Requirement Under 503A of the Federal Food, Drug, and Cosmetic Act (FD&C), setting forth the FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Act. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use (or office stock).

The ASRS provided testimony to the FDA and submitted comments on two parts of the Draft Guidance. First, the ASRS urged the FDA for an exception to the prescription requirement that would allow physicians to continue to administer critically necessary compounded drugs to patients when such drugs are not available from 503B facilities, such as compounded intravitreal antibiotics that are only available through 503A compounding pharmacies, including acyclovir, amikacin, amphotericin, clindamycin, foscarnet, gancyclovir, and voriconazole. Currently, there are no 503B available agents for fungal or viral infections or in the event a patient is allergic to cephalosporins. 

Ironically, the FDA references in its Guidance an example of the need for ophthalmologists to have on hand compounded antifungal medication that may be critical to preventing vision loss, but as the ASRS pointed out to the agency, under its draft Guidance that would not be possible because antifungal antibiotics for intravitreal use are not currently available from any 503B facility.

Despite this plea for a common sense emergency exception, the FDA did not create one. It maintained its position that for each drug compounded under section 503A, the compounder must obtain a valid patient-specific prescription order before the compounder can distribute the drugs. The Guidance states: "We recognize that some state boards of pharmacy may authorize the writing of prescriptions that do not include individual patient names. Such prescriptions, however, do not meet the requirement of a patient-specific prescription in section 503A. Under section 503B, outsourcing facilities can fill such prescriptions if they meet the requirements of applicable state and federal laws."

Second, the ASRS requested that the FDA not include in its Final Guidance the recommendation to streamline the prescription process by including a specific statement regarding the prescription that would have been burdensome and redundant to the information in the patient record. The FDA did not include that recommendation in its Final Guidance.

Bottom line: Intravitreal antibiotics can be obtained from traditional compounding pharmacies (503As), but will require a prescription with patient's name. 

While the ASRS is disappointed with the FDA response, we will continue to advocate for our patients who need compounded medications that are not produced by 503B outsourcing facilities.

(Published December 28, 2016)