USP <800> Pharmacy Compliance

USP <800> Pharmacy Compliance:

Back in March of 2014 the USP (US Pharmacopeial Convention) published yet another intensive set of guidelines regarding the handling of hazardous drugs and their preparation with the release of USP <800> Pharmacy Compliance. Many Pharmacists still remember the 2008 release of the update to USP <797> and we have numerous clients who implemented the changes required for compounding hazardous medications so that the result is a sterile parenteral product. The initial attempt in 2008 was a step in the right direction, but fell short by not having non-parenteral compounding guidelines. Even so, <800> was then hotly debated, criticized and revised. Finally on February 1, 2016, USP <800> was approved. Now implementation of <800> for handling hazardous drugs in all health care settings is a must. Yet after 10 months many Pharmacies and compounding facilities are asking how.

The need for such guidelines is not in question. All prior evidence linked the handling of hazardous drugs to increasing a workers chances for cancer and reproductive issues (as well as the birth defects that have been well documented). Add to this all the media attention over the past few years regarding the FDA and hazardous drug contamination from several specialty pharmacies that resulted in meningitis and patient deaths. The risks of handling hazardous drugs have been known since the early 1980s. The problem that a Pharmacy faces is the never ending changing of these regulations. It has been documented that so far there have been over seventeen guidelines published by six separate Federal agencies and other Healthcare organizations!

Legal Issues –
USP <800> is both a State & Federal standard. What that means is that inspections by both State Boards of Pharmacy and the FDA can cite a Pharmacy for non-compliance. Although compliance is mandatory, the issue is that “current legislation governing sterile product compounding is a patchwork of state-specific regulations with wide variations between jurisdictions” according to a recent article in Pharmacy Times. As the article notes, even though USP <797> is legally enforceable and the industry standard despite state legislation, less than half of state regulations specifically reference USP <797> for sterile compounding.

So far no inspections have occurred that we are aware of regarding USP <800> compliance. However, State Pharmacy Boards have conducted inspections ensuring compliance with USP <797> standards (Florida, California, Texas and Minnesota).

Current legislation governing sterile product compounding is a patchwork of state-specific regulations with wide variations between jurisdictions” according to a recent article published in Pharmacy Times

Actual Changes That Need To Be Implemented ASAP –
Basically USP <800> deals with hazardous drug manufacturing, including such key elements as compounding, preparing the drugs, storage, transport, product storage, compounding, preparation, and administration of parenteral and non-parenteral products. Obviously compliance is mandatory and will be enforced. So the question we all face is: Where do I start?

The core of the changes may actually cause many Pharmacy operations to actually have to change their workflow patterns. Additionally, the equipment specifications may require capital expenditures that will pose a major cash flow problem to many Pharmacy businesses. Although not intended as a legal summary of the USP <800>, here are the key points to focus on:

  1. Compounding, preparing & storing hazardous drugs must occur in an designated area that is separate from areas that non-hazardous drugs are dealt with and stored. Just as an example of the costs that may be involved in being compliant, negative pressure rooms intended for hazardous drug preparation & compounding cannot be used for non-hazardous medication compounding., USP <800> requires pharmacies to utilize a totally separate negative pressure room (plus an additional primary engineering control system) to be compliant!
  2. All hazardous medications are now required to be administered with the use of a CSTD (closed-system transfer device). This is to ensure safety to both nurses who administer the drugs, as well as the patients.

A 2014 study on USP <797> found that many Pharmacies were not compliant. The primary reasons cited were:

  • Financial and budgetary: 27%
  • Physical space limitations: 21%
  • Lack of training resources: 19%
  • Time restraints: 15%
  • Lack of management & leadership support: 5%

So the time to get compliant is now! Don’t put off putting together a Compliance Plan & Strategy until legal issues force you to. As always, please contact us here at HCC if you have any questions regarding this. With over 27 years in the Pharmacy Consulting business, HCC can assist with expert advice in any area of your pharmacy business or practice. We urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.


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