Pa. Pharmacy Board Publishes Pharmacy Compounding Regulations

Last Updated: Jul 3, 2019

PharmacyPennsylvania's State Board of Pharmacy (Board) has published final form regulations for pharmacy compounding. A proposed draft of these regulations was initially published in the March 11, 2017, Pennsylvania Bulletin. The proposed compounding regulations seek 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 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 asked 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.

In the preamble to the final-form regulations, the Board has responded to the concerns voiced by PAMED. The Board has made it clear that the regulations do not apply to physicians.

Regarding whether 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. The Board has responded that the intent of the regulations is to regulate pharmacists only and the regulations should not be construed to prohibit physician in-office compounding for administration to the physician’s own patients. The Board also noted that the Pharmacy Act does not provide the Board the authority to regulate practitioners other than pharmacists.

Regarding concerns relating to the dispensing and resale of compounded drug products, to eliminate confusion, the Board has removed those sections (§§27.604 and 27.605 in the proposed regulations) from the final-form regulation. Instead, the Board will rely on reference to Federal compounding requirements and the United States Pharmacopeia (USP).

The final publishing of these compounding regulations occurred in the June 22, 2019 edition of the Pennsylvania Bulletin. PAMED’s comments were again noted in this publication.

PAMED will continue to monitor any additional developments concerning these regulations and will share all updates with members.

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