Pharmacy OneSource Blog

States Vary Widely in Regulations for Sterile Compounding

Posted on 06/15/16

states_vary_widely_in_regulations_for_sterile_compounding.jpg

An analysis by Pew Charitable Trusts discovered that only 50 percent of states require compounding pharmacies that make sterile products to comply with quality standards.1 Additionally, 60 percent of states do not require compounding pharmacies to report adverse effects stemming from “sterile” compounding.

A total of 16 states do not track compounding pharmacy activity, while 28 states permit traditional compounding pharmacies to provide drugs to patients without prescriptions.

The FDA regulates and oversees all commercial pharmaceutical manufacturing. However, states are the regulators of hospital and freestanding pharmacies, including in-store facilities in retail and specialty pharmacies (for example, oncology clinics).2

Each state has its own Board of Pharmacy regulations to guide pharmacies and create standards for safety. Additionally, every jurisdiction has varying requirements for storage, recordkeeping, patient prescriptions, labeling and so on. Under state laws, pharmacies may be granted the authority to compound pharmaceutical ingredients for patients. Some of these regulations date back as far as 50 years ago, which means they were developed at a time when drug manufacturers did not play a large role in the medication industry.

However, it’s important to note that each state has a Board of Pharmacy. Under this organizational structure, pharmaceutical standards of practice are periodically updated to reflect the changing landscape.

Progress Following the Meningitis Outbreak

After the 2012 meningitis outbreak, the National Conference of State Legislatures (NCSL) began tracking the state regulations of compounding pharmacies.3 On its website, the NCSL keeps an up-to-date list of changes made by states to ensure safe, compounding practices. It also lists the status of these standards, informing readers of whether they have been enacted or remain pending.

The Drug Quality and Security Act passed in November 2013 stated that the FDA has the authority to regulate specialty compounded drugs, and it created a voluntary program for the FDA to regulate facilities engaged in batch compounding. The FDA gained permission to develop a track-and-trace system to secure the pharmaceutical supply chain as well.4

Many states have begun to adhere to USP Chapter 797, which provides guidelines for sterile preparations. USP 797 was revised in 2015  to provide more clarification in reference to sterile compounding of pharmaceutical preparations, and is pending final release by USP as an official chapter.5 In addition, a new USP chapter 800addressing Hazardous Drugs compounding was released earlier this year.6 However, the recent data from Pew Charitable Trusts shows that there is still much work to be done.

sterile compounding

 

References:

  1. State Oversight of Compounding Pharmacies Varies Dramatically. American Pharmacists Association. Published February 25, 2016: https://www.pharmacist.com/state-oversight-compounding-pharmacies-varies-dramatically
  2. State Regulation of Compounding Pharmacies. National Conference of State Legislatures. Published October 1, 2014: http://www.ncsl.org/research/health/regulating-compounding-pharmacies.aspx
  3. Cauchi, Richard. Noble, Ashley. New Report Examines Updates to Compounding Pharmacy Law. National Conference of State Legislatures. Published on June 6, 2014: http://www.ncsl.org/blog/2014/06/06/new-report-examines-updates-to-compounding-pharmacy-law.aspx
  4. H.R. 3204 – 113th Congress. Congress.gov. Published November 27, 2013: https://www.congress.gov/bill/113th-congress/house-bill/3204
  5. Pharmaceutical Compounding – Sterile Preparations. USP.org. Retrieved March 15, 2016: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf
  6. USP Chapter 800. USP.org. http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

Topics: Sterile Compounding

About the Author

Deb Oroszlan is the Marketing Director for Pharmacy OneSource - Wolters Kluwer.