If you own or manage a pharmacy, you’ve probably heard about USP <800>, the newest chapter issued by the United States Pharmacopoeial Convention. Although USP guidelines typically apply to compounding pharmacies and drug manufacturers, USP <800> guidelines apply to any facility which handles hazardous drugs; if you own or operate a pharmacy, that means YOU.

However, there is a common misconception spreading through the independent pharmacy space when it comes to USP <800> compliance. In part 2 of the Independent Pharmacist’s Guide, PRS takes it upon itself for explaining the USP <800> compliance and enforcement aspects to help dispel the popular myths and general confusion surrounding them. Let’s begin with the most repeated question: does my pharmacy need to comply with USP <800>? Well … some consulting entities and individuals are claiming that every pharmacy needs to be fully USP <800> compliant, but that is simply not the case.



Do I Need to Be USP <800> Compliant?

USP <800> – formally known as USP General Chapter <800> Hazardous Drugs — Handling in Healthcare Settings – is a set of standards regarding the safe handling of Hazardous Drugs in any healthcare setting. It is produced and promulgated by the US Pharmacopeia, a non-profit NGO that sets standards which are adopted by many governmental enforcement agencies.

The first thing to understand is that the U.S Pharmacopeia (USP) is not a regulatory agency. They have no jurisdiction over the adoption or enforcement of their standards. The choice to adopt and enforce a USP standard is up to regulatory agencies like the FDA, OSHA, State Boards of Pharmacy, and accreditation organizations.

The FDA and OSHA have not laid out any plans for the adoption or enforcement of USP <800>.  Now, it needs to be mentioned that the FDA requires compliance with USP <795> and <797> for all 503a and 503b pharmacies (you can find out more about 503a and 503b pharmacies here). The new 2019 versions of USP <795> and <797> required compliance with USP <800>, but these 2019 standards have been postponed and are currently under review.  OSHA only requires compliance with its own Hazard Communication Standard (HCS). You can find more information about the HCS here.

When explaining about the USP <800> compliance requirements, PRS finds it worthwhile to mention that regardless of the need for compliance, just like other regulatory standards, following the USP <800> standards would nonetheless help ensure a safe working environment for employees, which in turn would also increase the safety for patients.

Do the State Boards of Pharmacy Require USP <800> Compliance?

As for the State Boards, they span a broad spectrum of possibilities. Therefore, you will need to check with your State Board to see what it requires when it comes to USP <800>. In general, you may see one of these five basic responses:

  1. Not required;
  2. Required for all pharmacies that handle hazardous drugs (including non-compounding);
  3. Required for all pharmacies compounding with hazardous drugs;
  4. Required for only pharmacies compounding sterile products with hazardous drugs;
  5. Some variation of the above with additional requirements.

Do Accreditation Organizations Require USP <800> Compliance?

You should inquire with any pharmacy accreditation organizations as to what the standards currently state about the handling of hazardous drugs.  It may be best to also ask whether they are moving in the direction of requiring USP <800> compliance in a future update. The possible answers from the accreditation organizations may be similar to that of the State Board of Pharmacies or they may come to different determinations. Ultimately, you will need to follow the more stringent requirements.

Additionally, we may start to see other entities begin requiring compliance with USP <800>.  These could include payer sources and your pharmacy’s workers’ comp insurances, but, to-date, we have not been made aware of any of these entities actually requiring USP <800> compliance.

Latest Updates on USP 797’s 2019 Revisions

Early in 2020, in the final appeal hearing decision, the 2019 revision of the USP 797 was remanded. As a consequence, USP 797’s 2019 revision is no longer enforceable. At this point it is also unclear which parts of the chapter will be revised in the future. Of course, if USP 797’s 2019 revision had been accepted, it would have been necessary for all healthcare organizations, pharmacies, and any entities that deal with hazardous substances to comply with USP 800. Therefore it goes without saying that whenever a revision of 797 is approved or becomes official, it would automatically make the USP 800 enforceable. At this point however, it is the prerogative of the pharmacy to decide whether it would like to follow USP 797’s 2008 or USP 800 standards for the handling of hazardous substances. But it’s important to first know the requirements of the State Board and accreditation organization, which brings us to the next section.

Next Steps

The first thing you should do is contact your State Board of Pharmacy and accreditation organization about their requirements with regard to USP <800>.  If they are going to require your compliance with USP <800>, you will need to begin reviewing the USP <800> Standards and the NIOSH List of Hazardous Drugs.  Then you will need to begin creating your Standard Operating Procedures (Policies and Procedures) to comply with USP <800>.

If you need assistance, PRS has created the USP800Track Program to help independent pharmacies with any and all USP <800> compliance needs.  You can find information about our USP800Track Program here or you can give us a call at 1-800-338-3688.