Regulatory Standards

The Pharmacy Enterprise must comply with the regulations of the FDA, CDC, CMS, The Joint Commission, DNV Health Care, the New Jersey Board of Pharmacy, the EPA and the Board of Health. This past year the FDA required the Drug Supply Chain Security Act be implemented by all manufacturers and distributors to ensure counterfeit or tampered medications do not enter the supply chain. In 2016, the manufacturers and distributors are required to record and supply transaction history for pharmaceutical products on their invoice or in a retrievable database. The purchasing entity needs to obtain, store and be able to retrieve this information for all purchased products covered by this act. A corporate policy was developed and adopted and a process instituted to meet this requirement.

In 2015, the FDA proposed a new regulation, USP 800, to control the compounding of sterile and non-sterile chemotherapeutics and hazardous substances, and proposed revisions to USP 797, which controls how sterile IV medications are compounded. The final revisions to both of these regulations are scheduled to be implemented July 2018. The health system will begin implementation of these regulations at each system acute care affiliate and Qualitas. The health system clean room designs and processes at each facility were surveyed to ensure that the system facilities are in compliance with the new regulations.

CMS has determined that multi-dose vials, when used in a patient care area for a patient, must be considered as single use. This has forced us to review how we utilize medications in our OR’s and ED Departments in order to make certain that we are in compliance with this requirement. We are now treating some products that are only commercially available as multi-dose vials as single use containers in order to comply with this regulation.