Submitted electronically via Reg.Testimony@state.ma.us

November 28, 2017

Office of the General CounselDepartment of Public Health250 Washington StreetBoston, Massachusetts 02108

RE: Board of Registration in Pharmacy proposed new regulation 247 CMR 17.00, Sterile Compounding

Dear Sir or Madam,

Thank you for the opportunity to submit our written testimony on the Board of Registration in Pharmacy’s proposed new regulation, 247 CMR 17.00, Sterile Compounding.

The National Community Pharmacists Association represents the interests of America’s community pharmacists, including the owners of more than 22,000 independent community pharmacies. Together they represent an $80 billion health care marketplace and employ 250,000 people.

According to a recent NCPA member survey, more than 88 percent of our members provide some form of compounding services. Compounding, an inherent part of the practice of pharmacy, allows the prescriber and pharmacist to decide a proper course of therapy for each patient without being restricted to commercially available drugs or devices. NCPA supports the principles that pharmacist-compounded medications are customized medications and that compounding is a necessary service to meet the needs of patient care.

NCPA supports safety and quality in compounding activities and encourages compounding pharmacists to become accredited by the Pharmacy Compounding Accreditation Board to promote these conditions. We believe it is critical to balance the standards and expectations of safety and quality with patient care needs and access to medications.

NCPA believes that closer alignment of proposed new regulation 247 CMR 17.00 with current U.S. Pharmacopeial Convention (USP) guidelines, especially USP <797>, will provide that balance of providing adequate regulation to ensure the safety and quality of compounds while avoiding the creation of undue burden on compounding pharmacists and medication access issues for patients.

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NCPA recommends modifying sections 17.08, 17.24, 17.27, 17.28, 17.34, 17.35, 17.39, 17.40, and 17.41 to align with USP <797> guidelines.

NCPA recommends extending the deadlines proposed in sections 17.12, 17.13, and 17.20 by a minimum of eighteen months post-publication to ensure pharmacies engaged in sterile compounding have adequate time to comply with the regulations.

NCPA recommends modifying the following sections for clarification: 17.13(12): Consider allowing more cost-effective options that serve the same purpose as

an interlocking design. 17.13(14): Consider specifying types of appliances not allowed, such as “appliances

connected to a water source,” instead of prohibiting all appliances in general. 17.30(10): Consider modifying to specify individuals performing aseptic or sterile

compounding. 17.34(7): Consider modifying to require incubation of general growth media at

appropriate temperatures to promote bacterial and fungal growth instead of requiring two different growth media.

17.39(5c): Consider replacing “human-use” with “pharmaceutical grade.”

NCPA recommends removal of the following sections: 17.06(5): Commercially available products may contain excipients that are intolerable to

a patient and compounding from APIs may be necessary. 17.06(8): Technologically advanced multiple use containers are currently available that

prevent contamination of preservative-free formulations of high-risk level CSPs. 17.15(1a): There is currently no evidence or standard regarding appropriate minimum

room size. 17.15(2d): There is currently no evidence or standard regarding appropriate minimum

room size. 17.18(7): Requiring this level of monitoring to all non-classified areas of a pharmacy

would place a costly, undue burden upon the pharmacy. 17.22(2b): There is currently no evidence that smoke studies improve quality, and this is

an optional test within CETA requirements. This could place a costly, undue burden upon the pharmacy.

17.22(3c): Environmental monitoring results could take up to seven days to be obtained and halting all sterile compounding for this length of time could place an undue burden upon patients and the pharmacy.

17.23: There is currently no evidence that smoke studies improve quality, and this is an optional test within CETA requirements. This could place a costly, undue burden upon the pharmacy.

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NCPA would like to highlight a number of sections in the proposed new regulation 247 CMR 17.00 that will have a costly impact on the operation and construction of small compounding pharmacy businesses in the state. NCPA appreciates the Board of Registration in Pharmacy’s filing of its Small Business Impact Statement with the state’s Secretary of State but would like to provide comments on some of the answers provided in the statement.1 Specifically, NCPA believes some of these requirements will require small compounding pharmacies to hire additional employees beyond third party vendors and could deter the formation of compounding facilities in the state. Further, NCPA would like to highlight and add to the Board’s response to the question regarding whether pharmacies will have to incur capital investments in order to comply with the regulation. NCPA believes that many pharmacies will have to make significant capital investments to their facilities in order to comply with the proposed new regulation 247 CMR 17.00. Thus, we urge the Board to consider alternative regulatory methods that would minimize the adverse impacts on small businesses. We have suggested some of the following below:

17.13(7): An interlocking design is very costly and may not be possible to implement in all sterile compounding labs without extensive reconstruction.

17.13(23): Installing sprinkler heads that will withstand weight-bearing loads on the ceiling would be difficult and costly to implement and would outweigh any presumed additional benefit.

17.15(1a): There is currently no evidence or standard regarding appropriate minimum room size. Arbitrarily setting a minimum room size may require some sterile compounding labs to undergo extensive and costly reconstruction with no added benefit.

17.15(2d): There is currently no evidence or standard regarding appropriate minimum room size. Arbitrarily setting a minimum room size may require some sterile compounding labs to undergo extensive and costly reconstruction with no added benefit.

17.18 (7): Requiring this level of monitoring to all non-classified areas of a pharmacy would place a costly, undue burden upon the pharmacy.

17.24(8): The frequency proposed could require sterile compounding pharmacies to perform daily environmental monitoring. This level of monitoring would result in greatly increased operating costs and the need for additional pharmacy personnel.

17.34(6): Testing at this frequency could require sterile compounding pharmacies to hire additional pharmacy personnel to perform and monitor gloved fingertip test media, resulting in greatly increased costs to the pharmacy. There is no evidence of benefit for this testing frequency.

17.43 (2)- Requiring the verification of every MFR would limit the formulations that sterile compounding pharmacies could prepare and would incur greatly increased costs.

1 See http://www.sec.state.ma.us/spr/sprpub/110317e.pdf

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NCPA believes the fiscal effect of proposed new regulation 247 CMR 17.00 outweighs its benefit in its current form. We look forward to continuing this important conversation with the Board on resolving the issues mentioned.

NCPA appreciates the opportunity to share our comments and suggestions with you. If you have any questions, please contact Allie Jo Shipman, Associate Director, State Government Affairs at 703-600-1179 or alliejo.shipman@ncpanet.org.

Sincerely,

Ronna B. HauserVice President, Pharmacy AffairsNational Community Pharmacists Association