USP and Retail Pharmacies

In 2017, the United States Pharmacopeia (USP) and the Food and Drug Administration released a set of updated guidelines that cover the handling of hazardous drugs. Called the USP <800>, the rules are designed to promote patient and worker safety and environmental protections.

These guidelines are often assumed to only apply to compounding pharmacies, but when the rules go into effect on December 1, any pharmacies with hazardous drugs on their shelves will be expected to comply. This includes both retail and LTC pharmacies. Non-compliance could mean that both the pharmacy and the pharmacist-in-charge will lose their licenses and be fined.

Pharmacies that may be affected have only a few months left to ensure they are ready for inspections from the state boards of pharmacies and the Department of Environmental Resources. So what can you do to ensure compliance before the deadline?

In a recent blog post, pharmacy compliance consultants R.J. Hedges break down the specifics of the USP <800> and how pharmacies can ensure they are prepared. They recommend the following three steps to get started:

1. Create a hazardous drug inventory: This should include drug names and types (capsules, tablets, etc.), the type of exposure that may occur, if personal protective equipment (PPE) is required, and whether or not a safety data sheet (SDS) is available. You can compare against this NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

2. Get a safety data sheet for all hazardous drugs: Having the SDS on hand is a requirement, so R.J. Hedges advises pharmacies to get a hard copy. Once you have it, review the sheet to identify the requirements for PPE and safety precautions.

3. Segregate the hazardous drugs: This involves separating all hazardous drugs from the pharmacy’s drug stock on a separate shelf, room, or counter. This area should be marked by a “Hazardous Drug Storage Area” sign. Creating an inventory of incoming hazardous drugs when they are shipped in can help build a routine well before the deadline.

To learn more about what you need to do to be compliant, watch our on-demand webinar with R.J. Hedges’ Jeff Hedges. He’ll explain the specifics of the USP <800>, highlighting its implications for retail pharmacies and how they can ensure compliance ahead of December 1.