Compliance Review for Compounding Pharmacies

Compliance to USP 797 regarding Pharmacy Compounding is becoming an increasingly important issue for all compounding pharmacies to address as quickly as possible. Actions proposed recently by the Michigan legislature may be just the beginning of things to come. Directly related to the 2012 meningitis outbreak that has been linked to the now defunct New England Compounding Center (NECC), the Michigan Senate is considering a bill for additional compliance regulations for compounding pharmacies that even includes increased criminal penalties for many violations. Particulars of the proposed bill include:

–  Increased record keeping requirements
–  Mandatory bi-annual inspections
–  Designated Pharmacist In Charge at the facility
–  Ongoing licensing and accreditation requirements

In addition to the increased costs this legislation will cause to compounding pharmacies, there are several proposed punitive additions to the laws that must be considered:

–  Immediate suspension of the compounding pharmacy’s license upon notice of an imminent risk to public safety
– Civil penalties for offenses that include up to a 4 year prison sentence for violations that cause personal injury to consumers (and up to 15 years for infractions causing death).

Various studies to date have shown that many compounding pharmacies have been slow to react to the guidelines of US797 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

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 has been helping pharmacies 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.

Bob Miller
5/18/2014


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