How Could Pa. Pharmacy Board’s Proposed Compounding Rule Impact Physicians?

Pennsylvania's State Board of Pharmacy recently issued proposed regulations for pharmacy compounding. The proposal, published in the March 11, 2017, Pennsylvania Bulletin, seeks to incorporate developments and improvements in safe, sterile practices and procedures.

On April 7, 2017, the Pennsylvania Medical Society (PAMED) issued a comment letter to the State Board of Pharmacy, requesting clarification on the extent to which the proposed regulations will apply to physicians and other practitioners.

The letter from PAMED President Charles Cutler, MD, MACP, confirmed PAMED's support for safeguards to ensure drugs made in compounding pharmacies are dispensed at consistent and appropriate dosage levels for patients. PAMED's letter also asks the State Board of Pharmacy to clarify these three issues:

  1. Whether pharmacists may compound a drug in anticipation of receiving a prescription but may not dispense or send a drug to the prescribing practitioner until they receive the patient-specific prescription, i.e. that these regulations prohibit dispensing compounded drugs "for office use"? In addition, do the proposed regulations limit a physician's ability to order and purchase compounded drugs from the compounding pharmacy for the purposes of storing them in the office for future use?

  2. Do the regulations require a patient-specific prescription in order for a pharmacy to be able to send a batch of a compound drug directly to a physician for administration to that patient?

  3. To what extent, if any, do the Board's regulations prohibit or otherwise limit a physician from compounding drugs on their own in-office for administration to the physician's own patients?

View the full text of PAMED's letter here.

PAMED will monitor any developments concerning the proposed regulations and will share any responses we receive from the State Board of Pharmacy.

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