With 2016 well underway, pharmacies of all sizes should review recent regulatory updates to ensure compliance with rules already in effect, and preparation for those to be implemented soon. Three, in particular, warrant a close look.
USP 797 Pharmaceutical Compounding – Sterile Preparations. The comment period for USP’s proposed revisions for compounding sterile preparations closed January 2016, and comments are now under review. If finalized as-is, USP 797 may publish by November 2016, at which time pharmacies will face significant changes, including:
• A more inclusive compounding definition requiring master formulation and compounding records for all batch and non-sterile compounding activities.
• A new term (in-use time) defining the time before which a manufactured product or compounded dilution bag must be utilized after it has been punctured.
• More environmental control requirements, including monthly viable air and surface sampling.
• Increased accountability for staff competency with visual observation of hand hygiene and garbing, and quarterly media fill and fingertip testing.
In October 2015, CMS incorporated USP 797 into its requirements for participation in Medicare and Medicaid programs, forerunning more stringent review by CMS and regulatory bodies related to pharmacy compliance with this chapter.
USP 800 Hazardous Drugs – Handling in Healthcare. This was approved and published in February 2016. It defines hazardous drug containment processes to promote patient safety, worker safety, and environmental protection.
While official implementation has been scheduled for July 2018, pharmacies should prepare now for time- and resource-intensive rules, including new requirements concerning:
• How hazardous medications, for both sterile and non-sterile compounding, are prepared, requiring potential changes to facility design.
• How hazardous medications should be stored (in a dedicated refrigerator inside a negative-pressure room with 12 or more air changes per hour).
• Ventilation and containment for compounding of hazardous drugs, requiring potential HVAC improvements.
Drug Supply Chain Security Act. Enacted in November 2013, this sets forth requirements to build electronic systems to identify and trace certain prescription drugs in the United States. Pharmacies should consider which aspects of the law they’re held accountable for now, and which aspects they will be held accountable for in the future. For example:
• As of 2015, pharmacies are required to establish systems for verification and handling of suspect or illegitimate products, and for storage of tracing information (i.e. transaction history, information, and statement) for six years.
• By 2023, manufacturers must mark packages with a product identifier, a serial number, and a lot number, an unprecedented amount of data which pharmacies must be equipped to store.
Pharmacies shouldn’t delay in preparing for these massive changes. FDA has already pushed the implementation deadline back from 2017 in light of the challenges they present.
Amidst ever-changing healthcare requirements, pharmacies must stay up-to-date with regulatory and government standards. Pharmacists are encouraged to proactively check industry and government resources for updates that may help promote patient safety and minimize the risks of non-compliance.
Kenneth Maxik, director of patient safety and compliance for CompleteRx, has worked with hospitals for more than 20 years on a range of pharmacy operations and management issues.