July 13, 2017

The Commonwealth of Massachusetts

Executive Office of Health and Human Services

Department of Public Health

Bureau of Health Professions Licensure

Board of Registration in Pharmacy

239 Causeway Street, Suite 500

Boston, MA 02114

Re: Proposed Regulation—247 CMR 9.00

Dear Members of the Massachusetts Board of Registration in Pharmacy,

Parata Systems appreciates the opportunity to testify with regard to the proposed new rules of 247 CMR 9.00. Parata Systems is a provider of pharmacy automation and places a high priority on designing our systems to enable our pharmacy customers to be compliant with federal and state laws and regulations. It can be a challenge to determine the intent of rules once they are in place and, for this reason, Parata Systems is grateful for the opportunity to express concern with the language of draft rule 247 CMR 9.11 (1)(d). The proposed language for this part is:

(1)  A pharmacy may utilize Pharmacy Processing Automation (“PPA”) to count, fill vials or specialty packages, and label, provided the following requirements are met:

(d) the PPA utilizes two separate verifications, such as bar code verification, electronic verification, weight verification, radio frequency identification (RFID), or another similar process, to ensure that the proper medication is dispensed from the system;

We interpret the requirement for “two separate verifications” in this section to indicate that, using any of the technologies listed or another similar process, two instances of verification are required during the dispensing process in Pharmacy Processing Automation in order to ensure proper dispensing from the system. However, given the current language of the rule, we realize that this instead might be interpreted to mean that two different modes of verification are required, i.e., systems would be required to use two of the types of verification processes listed in the rule in the dispensing process.

We support the implementation of rules for pharmacy automation in order to promote patient safety and to provide pharmacies with clarity on requirements for compliance. We ask that you consider amending the language of 247 CMR 9.11 (1)(d) to clarify whether the requirement is for two instances of verification or two modes of verification in order to avoid misunderstanding of the requirements for the use of Pharmacy Processing Automation and verification in those systems.

We thank you for this opportunity to testify and for your consideration of our comments.

Sincerely,

Joanne M. Volosky, Ph.D.

Manager, Intellectual Property & Regulatory Affairs