Analysis

State Reforms to Strengthen Drug Compounding Policies

In the years following a major outbreak of meningitis linked to contaminated compounded drugs, many states have sought to strengthen their policies around this practice

Changing state policy can take time, and state regulators who are advancing reforms may encounter resistance. A report released this month by The Pew Charitable Trusts finds that many differences in state oversight systems continue to exist. But a number of states have begun the process of policy change, and others have already succeeded in passing important new laws that protect patients.

In Massachusetts, legislation passed in 2014 included significant measures to better regulate sterile compounding—the preparation of injection or infusion medications. The law requires a special license to conduct this activity, and sterile compounding pharmacies must report to the state the drugs they dispense annually. All pharmacies are also required to report any serious adverse events associated with the drugs they produce.1

North Carolina re-examined its policies after the meningitis outbreak as well. As of January 2015, pharmacists must adhere to the best practice quality standards for sterile and nonsterile compounding set by the U.S. Pharmacopeial Convention (USP). Updated rules also clarified that traditional pharmacies can compound only pursuant to patient-specific prescriptions, to align with recently updated federal law.2

Ohio updated its Administrative Code to require compliance with USP compounding standards in fall 2015.3

And this year, Georgia issued a notice to pharmacies compounding without prescriptions that this practice conflicts with federal law, and in order to continue they must register with the Food and Drug Administration as an “outsourcing facility”—a new category of compounders required to meet more rigorous quality standards enforced by FDA.4

This is by no means a comprehensive list of policy changes and does not describe the reforms still under consideration. Pew worked with an advisory committee of state pharmacy regulators and experts in compounding quality to develop a set of best practices to help inform state approaches. The landscape of state compounding policy remains in flux, and stakeholders should support states in their policy reform efforts.

Elizabeth Jungman directs Pew’s work on public health related to antibiotics and innovation, drug safety, and prescription drug abuse.

Endnotes

  1. Commonwealth of Massachusetts, “Bill H. 4235: An Act Relative to Pharmacy Practice in the Commonwealth,” enacted July 2014, https://malegislature.gov/Bills/188/House/H4235.
  2. North Carolina Board of Pharmacy, “Final Compounding Rules Jan 2015,” January 2015, http://www.ncbop.org/LawsRules/FinalCompoundingRulesJan2015.pdf.
  3. Ohio Administrative Code, “4729-16-03: Drugs Compounded in a Pharmacy,” http://codes.ohio.gov/oac/4729-16-03.
  4. C. Richard “Rick” Allen, director, Georgia Drugs and Narcotics Agency, “Georgia State Board of Pharmacy (Board) Requirements for Office Use Drug Compounding,” letter (Jan. 20, 2016), https://gbp.georgia.gov/sites/gbp.georgia.gov/files/related_files/press_release/Office Use Compounding Letter.pdf.

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