State Regulations Regarding Sterile Compounding

State Regulations Regarding Sterile Compounding

Michael Pavlik, Pharm. D. Candidate 2017, Ferris State University

Background

USP <797> is a chapter of the United States Pharmacopeia that outlines proper sterile compounding and regulations for any pharmacy that produces sterile compounding products. Before USP <797>, the U.S Food and Drug Administration (FDA) found that nearly one out of every three sterile compounded products contained some degree of deficiency. The chapter USP <797> was first published in 2004 to regulate sterile compounding pharmacies and laboratories to guide safer practices nationally. Since the initial publication, there have been many revisions to this chapter with the most recent in January of 2016.

As of April 2012

At the time this article was published, 8 years have passed since USP chapter <797> became the national standard for sterile compounding. Despite a national standard, state laws and regulations vary widely in regard to referencing USP <797>, whether it be full compliance requirements or no mention at all. In 2011, five states (including Michigan) had no laws or regulations that reference sterile compounding or parenteral nutrition practices in any way. The majority of the remaining states at this time had laws that did not specifically site USP <797>, but had regulations in place regarding sterile compounding and parenteral nutrition. Whether or not states had laws and regulations that were in compliance with, or referenced USP <797>, the average actual compliance rate was only 73.3 percent With such a large margin of non-compliance regarding USP <797>, it is not difficult to understand why new laws and regulations are becoming more popular within states.

Newer Regulations – June 2014

Governor Rick Snyder signed a new law that regulates compounding pharmacists and pharmacies for both sterile and non-sterile pharmaceutical products. This law also included penalties and sanctions for certain violations. A larger influence for this comprehensive law was the fungal meningitis outbreak in fall of 2012 in which Michigan suffered the most infections and highest number of fatalities. This outbreak was tracked by the Centers for Disease Control and Prevention (CDC) and was attributed to contaminated epidural steroid injections from a compounding facility in Massachusetts.

The new comprehensive law amends parts 161 and 177 of the public health code and includes, but is not limited to, the following:

1.      Any applicant for a pharmacy license that involves compounding must submit verification of accreditation through a national organization.
2.          Pharmacies cannot compound commercially available products unless the product is significantly different from an already available product.
3.   .      Any pharmacy charged with a violation out of state or with federal law must notify the Department of Licensing and Regulatory Affairs (LARA) within 30 days.
4.          There are criminal penalties imposed for violations of certain provisions and requirements and a license may be suspended if an imminent risk to public health or safety is reported from the FDA or CDC.

Current Regulations in Michigan compared to other states

Since legislature regarding sterile compounding has become more popular since the meningitis outbreak in 2012, the National Conference of State Legislators (NCSL) began holding records of state laws on this topic. The NCSL holds records on whether or not the state compounds sterile preparations, if they comply with the USP, how many pharmacies are accredited in that state to compound sterile products (voluntary) and recent additions to sterile compounding laws within each state. According to the NCSL’s website, 21 states currently do not practice sterile compounding (16 of which have compounding pharmacies that are accredited by the Pharmacy Compounding Accreditation Board) or are pending approval, three states use state regulations instead of USP regulations and 26 states have pharmacies that compound sterile products and follow USP regulations. According to the NCSL’s current website, Michigan is one of the states that does not yet follow USP regulations but has pharmacies that are accredited by the Pharmacy Compounding Accreditation Board.

            

Michigan’s newest laws regarding sterile compounding were released in 2014 and signed by Governor Snyder including those outlined above. These new laws distinguish Michigan from other states in a number of ways. In Florida, for example, a sterile compounding facility must apply for a permit from the state instead of a national accreditation program. The sterile compounding permit requires a background and history check, and has statues that outline punishment for failure to comply. In Texas, it is also illegal to compound sterile products that are commercially available and the pharmacy must also receive national accreditation status. Since the early 2010s, regulations requiring national or state accreditation have become ubiquitous to ensure safer compounding measures for sterile compounds. More stringent guidelines for accreditation and sterile compounding practice have been implemented, and pharmacies across the nation have been increasingly compliant with new standards. As time goes on, there will likely be a continuous reevaluation and adaptation to sterile compounding standards across the nation.

References

http://www.pharmacy.texas.gov/files_pdf/comparison%20final.pdf

http://www.michigan.gov/documents/lara/Compounding_Pharmacy_New_Law_Memo_09-2014_468552_7.pdf

http://floridaspharmacy.gov/licensing/sterile-compounding-permit/

http://www.pppmag.com/article/1113/april_2012_state_of_pharmacy_compounding/state_regulations_impact_usp_797_compliance/