On December 6, the Board of Pharmacy published new regulations relative to pharmacy licensing and the Continuous Quality Improvement Program.
Amendments to 247 CMR 6.00
Created six new license categories for certain types of pharmacy practice:
- sterile compounding,
- complex sterile compounding,
- institutional sterile compounding,
- non-resident drug stores,
- non-resident sterile compounding,
- non-resident complex non-sterile compounding.
The proposed changes explain which license types are needed for which activities, set forth the eligibility requirements and procedures for obtaining each type of license, and set forth grounds for denial of licensure due to lack of suitability. The proposed changes update requirements related to the change of a pharmacy’s manager of record, location or ownership, pharmacy renovations and the closure of a pharmacy. The proposed changes remove practice standards from this section in order that all such practice standards may be aggregated at 247 CMR 9.00.
Amendments to 247 CMR15.00
Requires pharmacies to establish and implement a “Continuous Quality Improvement Program,” meaning a system for identifying and documenting prescription dispensing errors; notifying affected patients, and health care providers as necessary; analyzing the error to identify causes and contributing factors; and using the information to improve pharmacy systems and workflow.
For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.