Last Call for USP Chapter <800>

On December 1, 2019, changes will go into effect that impact pharmacies, pharmaceutical manufacturers, and wholesalers. The United States Pharmacopeia (USP) introduced its new chapter <800> on handling hazardous drugs. Regulatory agencies worldwide will begin enforcement on December 1, 2019.

The USP initially announced a June 1, 2019 rollout for chapter <800>, but a six-month extension has provided pharmacies, long-term care facilities, and other affected entities increased time to bring their facilities and standard operating procedures up to code.

Several important considerations exist for pharmacies and other entities that handle hazardous drugs:

  • New requirement for externally vented, negative pressure labs for manipulations (other than counting or repackaging) of hazard drugs (HDs)
    • Splitting/crushing (HD) tablets no longer allowed in regular workspace
  • New requirements for designated areas for receipt, unpacking, and storage of HD

For more information on compounding and handling hazardous drugs, full chapters are available for free download at:

While facilities dedicate significant energy, time, and resources into finalizing compliance, new regulations on hazardous waste (HW) disposal from the Environmental Protection Agency (EPA) have already gone into effect. August 21, 2019 marked the federal effective date of EPA’s Resource Conservation and Recovery Act (RCRA) Part 266 Subpart P policy on hazardous waste pharmaceuticals.

New requirements for HW management under Subpart P may prove costly for both pharmacies that produce over 220 lb. of hazardous waste in one calendar month and for manufacturers that function as reverse distributors.  Key takeaways include:

  • Sewer prohibition: HW pharmaceuticals may not be disposed of down the drains or flushed
  • Requirements for EPA-approved HW transporters for shipment of non-creditable HW pharmaceuticals
    • Non-creditable HW pharmaceuticals —defined as pharmaceuticals that do not have a reasonable expectation to be used/reused or reclaimed—must be shipped using an EPA-approved HW transporter
    • Potentially creditable HW pharmaceuticals—those in original packaging, undispensed, and expired less than one year–have a reasonable expectation to receive manufacturer credit. Potentially creditable products can be shipped from healthcare facilities using common carriers (e.g., UPS, USPS, FedEx)
  • New standards for residues remaining in “empty” containers:
    • “Empty” containers are defined as empty vials, syringes, unit-dose, and stock/dispensing bottles smaller than 1 liter or 10,000 pills
    • Residues of empty containers are not regulated as HW, but containers larger than these sizes are deemed as HW.

PHSI’s view is that manufacturers and distributors of bulk package-sized hazardous drugs, such as warfarin and spironolactone, should take a closer look at the new EPA and USP <800> regulations. Buyers may become more hesitant to purchase large quantities of hazardous pharmaceuticals. Hazardous drugs deemed broken/leaking, repackaged, dispensed, and expired past 1 year automatically become classified as non-creditable HW. An increase in generated hazardous waste each month may result in a healthcare facility becoming required to abide by all sections of Subpart P.  Subpart P went into effect on Aug 21, 2019 in Iowa, Alaska, Indian Country, and some U.S. territories. Remaining states have until July 21, 2021 to adopt the new regulations. Check with your state for specifics.

PHSI would like to thank our student, Carissa Dolan, LECOM Pharm.D. Candidate, for her contributions to this article.


Posted November 2019

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