Community Pharmacy Steps for USP 800 Compliance

by Charles Lager, RPh, MBA, Senior Pharmacy Advisor

Keeping up with regulatory changes can be overwhelming, and we at The Compliance Team know our pharmacy clients have more than enough “homework” to do every day (we’re right there with you!). Yet, it is extremely important to make time to familiarize yourself and your staff with the USP 800 standards that apply to your pharmacy to ensure that compliance is maintained.

USP 800 established quality standards for handling hazardous drugs (HD) in health care settings and aims to ensure the safety of patients, staff, and the general public, as well as for environmental protection. The standards apply to all health care personnel that handle HD preparations and all entities that store, prepare, transport, or administer HDs.

USP 800 standards became effective and enforceable December 1, 2019.
Some states have delayed full implementation so check with your state Board of Pharmacy to verify.

Below are steps that your pharmacy can take to meet the applicable Compliance Team accreditation quality standard:

1. Complete a Risk Assessment and identify any Hazardous Drugs (HDs) for Final Dosage Form

Final dosage form is when a HD is packed by the manufacturer in a pill or capsule and the pharmacy only counts and repackages them. The existing practices you use to manage this workflow is most likely in compliance. However, there are steps you need to be aware of to comply with 800. You must segregate your HDs from your regular stock. How you segregate these drugs, whether it is on a shelf or a rack, is up to your discretion, if it is segregated and labeled as a “Hazardous Drugs Storage Area.” The assessment of risk shall be performed and documented annually.

• • Identify any drugs from the National Institute of Occupational Safety & Health (NIOSH) list:
    • Antineoplastics, non-antineoplastics, reproductive only hazards
    • Any drug identified by at least one of the following criteria:  carcinogenic, teratogenic, or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxic and similar drugs whose structure and toxicity are similar to existing drugs.

2.  MUST have a Policy & Procedure addressing receipt, storage, compounding (if applicable), dispensing, and disposal.

3. Inventory Consideration Tips:

• • Identify HDs by unique bins or shelf sticker
  • When possible, buy any HDs in Unit of Use packaging
  • Use separate equipment for chemo drugs
    • Designated counting tray and spatula
    • Wear chemo gloves tested to ASTM D6978
    • Decontaminate tray after using
  • Store HDs in separate and identifiable bins
    • Clearly note what must be done if manipulation of dose is required
  • Ensure HDs are dispensed or returned a minimum of nine months prior to the expiration date
    • • Trace HD waste includes empty vials with dust or other HD residue in the containers.  This waste must be disposed of in a licensed HD waste landfill.  Expired HDs are also considered hazardous waste.

 4. Personnel Requirements

• • You MUST have a DESIGNATED PERSON assigned to oversee the program.
  • Personnel of reproductive capability MUST confirm in writing that they understand the risks of handling HD’s.
  • Demonstration of competency MUST be documented every 12 months.
  • Appropriate Personnel Protective Equipment (PPE) MUST be worn when handling HD’s including during:
    • Receipt, Storage, Transport, Compounding, Administration, Cleaning, Spill Control and Waste Disposal

The Compliance Team will strive to keep all our Pharmacies informed of any changes as they may occur. You may also go to https://www.usp.org › general-chapter-hazardous-drugs-handling-healthcare for more detailed information.