PREAMBLE

Numerous state boards of pharmacy have concerns about United States Pharmacopeia (USP) Chapter <800> Hazardous Drugs-Handling in Healthcare Settings.

• The official chapter goes beyond the walls of the pharmacy and into healthcare settings, including physician offices, clinics, hospitals, treatment centers, etc. where state boards of pharmacy don't generally have authority for enforcement.
• The requirements of <800> are very strict and extremely costly; many smaller pharmacies will no longer be able to serve their patients who depend upon compounded medications so they will simply cease compounding patient-specific medications, including some hospitals.
• There are some aspects of <800> that should be the burden of manufacturers and distributors, not pharmacies. As an example, no package should be delivered to a pharmacy contaminated with hazardous drug (HD) contents on the package surfaces that exposes pharmacy personnel upon opening. This is the responsibility of the manufacturer and distributor. No contaminated package should be allowed to be shipped into a state-licensed pharmacy; the manufacturer or distributor must be required to certify that their products (immediate container, packaging, shipping containers) are free of contamination.
• Many of the requirements of <800> are based upon "opinion" and not necessarily upon science as demonstrated by documented, prospective studies.

As state boards of pharmacy have options other than accepting USP <800> in its entirety, many will treat it as they have USP <795> and <797> and rewrite it to meet the needs of patients and pharmacies in their own state. The purpose of this document is to simply provide a resource from which state boards of pharmacy can "pick and choose" items to include for their respective state.

This document also introduces the concept of "Low-" and "High-" risk HD compounding. Many pharmacies provide compounding as a service to their patients preparing a relatively low number of compounded preparations. It is not cost effective to try to implement <800> under these conditions, as a risk assessment can show they have minimal exposure when done with less than a full <800> implementation. Also, the different sources of active pharmaceutical ingredients can impact HD exposure (powders, liquids, semisolids) and this is discussed as well as other documents related to HD compounding.

This document has been prepared using numerous resources, including USP, ASHP, NIOSH, etc. It is simply a resource that state boards of pharmacy can use to write their own regulations. There is nothing official about this document; it is simply a resource where part or all can be used as indicated. It is arranged in a bulleted format for ease of reading and for selecting/deleting specific items.

To download a free copy of the

"800" ALTERNATIVE FOR STATE BOARDS OF PHARMACY

-HANDLING HAZARDOUS DRUGS IN A PHARMACY-

Go to CompoundingToday.com

• On the left column about half way down, select USP Compliance.
• Fill in the:
  • Email address
  • First Name
  • Last Name
  • Company/Organization
• Click "Submit" and a link for the free 800 Alternatives document will be sent to you for the free download.

As an added note: There are now FIVE free documents that can be downloaded

1. one on USP <795>,
2. one on <797>,
3. two on <800>, and
4. one on an alternative "800" for state boards of pharmacy that do not accept USP <800> by reference and prefer to develop their own.

Next week, we will look at the pharmacogenomics of carbamazepine.

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Did You Know ...

�that in our every deliberation, we must consider the impact of our decisions on the next seven generations? (The Great Law of the Iroquois Confederacy)

Tip of the Week

How often do we think that our decisions only affect us? The decisions we make every day affect our family, friends, churches, schools, profession, politics, etc. The sad thing is that many don't consider what impact their decisions have, they just want to get their own way.

Unintended consequences result from every law, regulation, and standard that is developed. There may not be enough individuals participating to think things through thoroughly. Each individual needs to participate in decision-making with the facts. It has been said, "If it's true you can't take it with you, then maybe it's about what you leave behind." Hopefully, it will be well thought-out decisions in your sphere of influence.

Looking Back

Aid the blade!
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