USP 797 Compounding Pharmacy Compliance

USP 797 Compounding Compliance.

Compliance to USP 797 regarding Pharmacy Compounding is an ongoing and increasingly important issue for all compounding pharmacies to address as quickly as possible. Ever since the 2012 meningitis outbreak that had been linked to the now defunct New England Compounding Center (NECC), increased legislation is constantly being introduced regarding additional compliance regulations for compounding pharmacies. Many even include increased criminal penalties for many violations. Particulars of the some legislation and proposed bills include:
–  Vast increases in record keeping requirements
–  Mandatory bi-annual compounding pharmacy inspections
–  The designation of a Pharmacist In Charge at all compounding pharmacy facilities
–  Increased and ongoing compounding Pharmacist licensing and accreditation requirements

Various studies to date have shown that many compounding pharmacies have been slow to react to the guidelines of USP 797 regarding compliance. The most often cited reasons include:
– Leadership’s lack of knowledge &/or support
– Financial and budgetary restrictions
– Physical plant limitations
– Lack of available training & competency resources
– Time required to implement changes
Yet these excuses are simply that: excuses! The public has clearly stated through the increased legislation that it will not tolerate safety threats that have been associated with specialty and compounding pharmacies due to non-compliance to the guidelines of USP 797. As a result of the never ending mass media and negative publicity that the specialty and compounding pharmacy industry has received, the public realizes that a pharmacy’s commitment to continuous compliance significantly reduces the risk associated with using compounded prescriptions and medications.

One major step in “the right direction” is getting your compounding pharmacy’s Policies and Procedures in order. Having them reviewed and updated by a reputable third-party pharmacy consulting firm is the first step to getting USP 797 compliant. Another step is getting your compounding pharmacy certified and accredited by the Pharmacy Compounding Accreditation Board (PCAB) . PCAB was established in 2007 by eight of the prominent Pharmacy organizations in the United States to help ensure compliance to the United States Pharmacopeial Convention standards regarding compounding of drugs and medications.  It is important to note that in 2014 PCAB became a service of the ACHC (Accreditation Commision for Health Care, Inc.) and is NOT a governmental agency, nor are there any federal and/or state legislative requirements to have PCAB accreditation. It is interesting to note the results of a search that we conducted of the PCAB accredited locations from their website. Of the states located in the Southeast US that we service with staffing here at HCC, a search revealed the following results for PCAB accredited pharmacies:
Florida – 47
Texas – 60
Georgia – 8
Alabama – 18
North Carolina – 11
South Carolina – 5
What is extremely interesting is that there were only a total of 492 PCAB accredited locations, which means that over 12 percent were located in Texas and just under 10 percent were located in Florida. California (55) and New York (24) unexpectedly showed results for fewer accredited locations than anticipated. A couple of states actually had none (Delaware and Wyoming). Here is a list of all the states that had less than 10:
– Louisiana: 8
– Washington: 8
– Maryland: 7
– Kentucky: 7
– Oklahoma: 6
– Utah: 5
– Hawaii: 4
– Oregon: 3
– Nevada: 3
– Idaho: 3
– Alaska: 3
– Nebraska: 3
– West Virginia: 2
– New Hampshire: 2
– South Dakota: 2
– North Dakota: 2
– New Mexico: 2
– Maine: 2
– Rhode Island: 1
– Montana: 1
– Colorado: 1
– Vermont: 1
Seems like a lot of opportunity is available in a lot of states!

If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. HealthCare Consultants Pharmacy Staffing has been helping pharmacies for over 27 years now (since 1989). Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.


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