EXECUTIVE SUMMARY

There are three primary differences in this "alternative" approach to United States Pharmacopeia (USP) <800> for consideration by state boards of pharmacy that do not incorporate USP <800> by reference and involve the following:

1. Contamination on immediate containers, cartons, and shipping packaging must be prevented and is the responsibility of the manufacturer/distributor, and not the pharmacist's responsibility; the pharmacy had nothing to do with the contamination prior to receipt.
2. A "carve-out" is provided for those pharmacies providing needed compounded preparations, but it is impractical for them to expend the large amount of money required for remodeling, additional equipment purchase, etc. This carve-out is based on a minimal number of hazardous drugs (HDs) to which personnel are exposed, as well as the actual form of the active ingredients (powders, liquids, semisolids, etc.).
3. With proper PPE and C-PEC and compounding a minimal number of preparations as defined as Low Risk HD Nonsterile Compounding, it is not necessary to have a separate negative pressure room that adds costs, both in construction and in operation (HVAC, etc.) and maintenance.

The remaining standards are generally still in place for consideration by the individual state boards of pharmacy; this alternative should provide a reasonable option for states to continue to allow access to needed compounded medications for patients of pharmacies utilizing either low or high numbers of compounded HD preparations. This document is formatted such that each state board of pharmacy can easily modify it to meet their own specific requirements.

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 four additional 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.

News

Seven NECC Defendants Seek November Trial
Seven remaining defendants in the federal criminal case stemming from the federal probe of a defunct Massachusetts drug compounding pharmacy (the New England Compounding Center) have requested November trial dates on their fraud and conspiracy charges.

The attorneys for the defendants said a November date would allow sufficient time for codefendant Glenn Chin's trial, which begins in August, to be completed. The seven defendants were to be tried in April but that date had to be canceled.
http://www.metrowestdailynews.com/news/20170417/necc-charges-seven-seek-november-trial

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Did You Know ...

�that no one on their deathbed ever said: "My one regret is that I didn't spend more time alone with my computer."

Tip of the Week

Whatever happened in America to the feeling that "we are all in this together"? Today, we tend to define ourselves by the things that divide us rather than the things we share. Our country has lost the shared values such as fair play, self-reliance, and duty that once united us and anchored our national identity. The more caught up we get in obtaining personal comforts and gratification, the less inclined we are to give up anything for the general good�let someone else do it. Relating this to our profession, in how many professional pharmacy organizations are you active?

Looking Back

Beard unruly?
Meet yours truly!
     Burma Shave