Last Updated: Apr 11, 2019
In April 2019, Pennsylvania's State Board of Pharmacy (Board) 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:
- 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?
- 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?
- 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.
How the Pa. Pharmacy Board Responded to Physician Concerns
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 Independent Regulatory Review Commission (IRRC) plans to meet and act on this regulation at a public meeting at 10:00 a.m. on Thursday, May 16, 2019. Comments may be submitted to the Board, firstname.lastname@example.org, and IRRC, email@example.com, before 10:00 a.m. on Tuesday, May 14.
PAMED will continue to monitor any additional developments concerning these regulations and will share all updates with members.