COMPOUNDING PHARMACIES

 
 

Full state list of recent laws: [26 pages; PDF format]

USP Plan to Revise Chapter on Sterile Compounding Preparations. On Oct. 7, 2015 the Compounding Expert Committee of the United States Pharmacopeial Convention (USP) proposed revisions to General Chapter <797> Pharmaceutical Compounding—Sterile Preparations to improve clarity and reflect stakeholder input. The revisions include reorganized sections, merging of microbial risk categories, removal of information on handling hazardous drugs and adding of cross-references to General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, and introduction of new terminology, “in-use time.”  On November 2, 2015, the proposed revisions were published for public comment. USP has made the chapter available in the online notice. The notice provides instructions for submitting comments, which were accepted until January 31, 2016.

NCSL Resources

Federal Resources

  • From the CDC: Multistate Outbreak of Meningitis and Stroke Associated with Potentially Contaminated Steroid Medication.  “On October 30, 2015, CDC updated its web resources for patients and clinicians. Patients affected by tainted steroid injections from the New England Compounding Center continue to receive treatment for their infections and clinicians should continue to monitor patient recovery. All relevant materials for patients and clinicians concerning the multistate outbreak of fungal meningitis and other infections are located on this page.”
  • From the FDA:
    • Compounding: Inspections, Recalls and Related FDA Actions- online database posted by FDA.
    • Outsourcing Facilities. The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.  An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from current good manufacturing practice (CGMP) requirements.  
    • Inter-governmental Working Meeting on Pharmacy Compounding - FDA webpage and resources, March 2015.
  • State of Disarray: How States’ Inability to Oversee Compounding Pharmacies Puts Public Health at Risk. “A report written by the staff of Congressman Edward J. Markey (D-MA) using the responses to an investigation launched by Reps. Edward J. Markey (D-MA), Henry A. Waxman (D-CA), John Dingell (D-MI), Frank Pallone (D-NJ) and Diana Degette (D-CO).” April 15, 2013.

Additional and Third Party Resources

PEW logo

This webpage is made possible in part through the generous support of The Pew Charitable Trusts.
 

For more information, members can contact the NCSL Health Program's Pharmaceutical Project.

Contact the authors:
Richard Cauchi, Program Director, NCSL Health Program.
Ashley Noble, Policy Specialist, NCSL Health Program.

Compounding Pharmacies and States

8/20/2016

prescriptionFor more than a century, American pharmacies have played a significant role in providing medications to patients. Compounding pharmacies are facilities where pharmacists create custom-made prescription drug mixes made for specific patients. Before mass production, compounding was the main way prescription drugs were made. Within this world of health providers, compounding pharmacies have been a necessary, but less visible, aspect of pharmaceutical policy. Compounding pharmacies continue to manufacture customized prescription drugs for patients for whom mass-produced prescription drugs are not appropriate. Such situations can arise when a patient has an allergy to an ingredient in a mass-produced drug or requires a dosage that is not manufactured on a mass scale. 

The Role of the States

The federal Food and Drug Administration (FDA) regulates virtually all commercial pharmaceutical manufacturing. However, states are the primary regulator of pharmacies, including community "drug stores," large chains, in-store pharmacy counters and specialty pharmacies. Every state has laws and regulations guiding pharmacy standards and requirements, addressing issues such as required licenses for each facility and for the credentialed pharmacists and other employees who work there. Virtually every jurisdiction also has requirements for secure storage, recordkeeping, the forms or pads used for patient prescriptions, labeling, and safety protocols related to origins, authenticity, chain of custody, expiration dates of products, purity, sterility and storage, among others. This includes the extra, explicit authority granted to "compound" or mix pharmaceutical ingredients into a patient-ready product. Numerous existing pharmacies have the authority to prepare such products for patients, based on prescriptions written by doctors or other prescribers. Some of these practice requirements have origins dating back 30 to 50 years, when large drug manufacturers played a much smaller role as the source of medication. State rules are updated periodically, commonly under the jurisdiction of individual state Boards of Pharmacy, which operate in the 50 states.

Federal Regulation

Although states have been the primary regulators of compounding pharmacies in the absence of federal laws addressing these facilities, in the wake of the 2012 meningitis outbreak that was traced to a compounding pharmacy in Massachusetts, federal regulators enacted the Compounding Quality Act. A summary of the act is available here. Click here for the full text of the law.

Compounding Pharmacy Issues

After the potential for harm posed by compounded drugs and compounding pharmacies was highlighted by the 2012 outbreak in Massachusetts, a number of regulatory issues emerged, including:

  • Compounding or manufacturing: Is it clear which compounded drug orders meet the state-regulated standard and which cross into a manufacturing regulatory category?
  • Definitions: Uniform and up-to-date definitions of compounding, wholesale, specialty and hospital-based pharmacies.  Clear language about "sterile" and "non-sterile" compounding.
  • Enforcement: Which agencies or boards, state or federal, take action when violations or omissions occur? What levels of penalties are in place? Who can order the closure of an operating pharmacy?
  • Funding: Inspection and enforcement agencies have varied levels of budgets and personnel to complete inspections and enforcement.
  • Inspection of facilities: How often, by whom, under what conditions. What kind of independent accreditation or evaluation is in place?
  • Single-use injectable drugs:  Vials sometimes are over-filled and have no preservative added. The makes costs higher, while repeat injection use by some providers brings additional dangers of contamination and infection.
  • Transparency: Are records of inspections publicly or adequately available to policymakers and federal and state regulatory entities?

Enacted Laws Affecting Compounding Pharmacies, 2011-Present

Compounding continues to be an issue of interest in the states. So far in 2016, five laws have been enacted in four states. Use the interactive map below to see a summary of laws enacted in each state since 2011. (Click on individual state outlines below).  [PDF format]