Drug Compounding: Survey of State Pharmacy Regulatory Bodies (GAO-17-363SP, March 2017), an E-supplement to GAO-17-64

Background

The Drug Quality and Security Act (Pub. L. No. 113-54), enacted in 2013, helped clarify the Food and Drug Administration's (FDA) authority to oversee drug compounding nationally and created a new category of compounders called outsourcing facilities. Outsourcing facilities compound sterile drugs and must register with and be inspected by FDA, among other requirements. In contrast to other drug compounders, outsourcing facilities are allowed to compound drugs without patient-specific prescriptions. In general, states oversee drug compounding as part of their regulation of the practice of pharmacy. As part of our report on drug compounding—Drug Compounding: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges, GAO-17-64 (Washington, D.C.: November 17, 2016)—we conducted a survey of state pharmacy regulatory bodies (e.g., boards of pharmacy) in the 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands, and all but 4 states completed the survey. Our survey collected information on the following: each state pharmacy regulatory body and its oversight responsibilities for drug compounding; pharmacists, pharmacies, and drug compounding in each state; types of state laws, regulations, and policies related to drug compounding; inspections and enforcement actions states can take related to drug compounding; states' perspectives on communication and interactions with FDA and other states, and any associated challenges; and states' perspectives on FDA's implementation of section 503A—the section of the Federal Food, Drug, and Cosmetic Act with requirements for drug compounders that are not outsourcing facilities—and section 503B—the section of the act that added outsourcing facilities—including any challenges that states reported on these efforts; among other things. We administered the survey from February 8, 2016, through April 15, 2016. A more detailed discussion of our scope and methodology is contained in appendix II of our report, GAO-17-64.

This e-supplement is a companion to GAO-17-64, and provides selected results from our survey, including additional data that are not included in the report. The survey results for selected questions can be accessed and downloaded from the table of contents links below. We are not presenting the full version of our survey results. For example, we do not include narratives provided in open-ended questions. We also do not include survey results for close-ended questions for which few respondents entered data or if the data reliability was questionable. The Department of Health and Human Services reviewed a draft of this e-supplement and informed us that it did not have comments.

We conducted the work upon which this product is based in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

Contents

PDF of GAO Survey of State Pharmacy Regulatory Bodies on Drug Compounding

GAO Survey of State Pharmacy Regulatory Bodies on Drug Compounding

I. State Pharmacy Regulatory Body Information

Table I.1: The Number of State Pharmacy Regulatory Bodies Reporting That Their Office Has Primary Responsibility for the Oversight of Drug Compounding for Human Use

II. Information on Pharmacists, Pharmacies, and Drug Compounding in Each State

Table II.1: The Number of States Reporting Whether They Can Differentiate Data on Drug Compounding for Human Use versus Animal Use

Table II.2: The Number of Active Licensed or Registered Resident (In-State) and Nonresident (Out-of-State) Pharmacists and Pharmacy Technicians, by Reporting State

Table II.3: State-Reported Categories of Licenses, Permits, or Registrations for Pharmacies and Other Entities, by Number of States

Table II.4: The Number of Licensed or Registered Resident (In-State) and Nonresident (Out-of-State) Pharmacies, by Reporting State

Table II.5: States Reporting Select Qualifications Required for Pharmacy Inspectors

Table II.6: The Number of States That Reported Conducting Joint Pharmacy Inspections with FDA Inspectors

Table II.7: Types of Entities Authorized to Prepare Sterile Compounded Drugs, by Reporting State

Table II.8: The Number of States That Reported Collecting Information on the Number of Licensed or Registered Resident (In-State) and Nonresident (Out-of-State) Pharmacies That Compound Sterile Drugs

Table II.9: States That Reported Data on the Number of Licensed or Registered Resident and Nonresident Pharmacies That Compound Sterile Drugs, Calendar Year 2015

III. Types of State Laws, Regulations, and Policies Related to Drug Compounding

Table III.1: Reported Laws, Regulations, or Policies Related to Drug Compounding, by Reporting State, as of January 1, 2016

Table III.2: States Reporting Whether Drug Compounding for Office Use is Authorized or Allowed in Their State

Table III.3: States Reporting Whether Anticipatory Compounding is Authorized or Allowed in Their State

Table III.4: Reported Provisions Related to Requiring a Separate License or Registration for Sterile Compounding, by Reporting State, as of January 1, 2016

Table III.5: Reported Provisions Related to Labeling and Testing of Compounded Drug Products, by Reporting State, as of January 1, 2016

Table III.6: Reported Provisions Related to Compounding Qualifications and Standards, by Reporting State, as of January 1, 2016

Table III.7: Reported Provisions Related to Reporting of Compounded Drug Products, by Reporting State, as of January 1, 2016

Table III.8: Reported State Licensing or Registration Requirements for FDA-Registered Outsourcing Facilities, by Reporting State

IV. Inspections and Enforcement Actions

Table IV.1: States Reporting Inspecting Resident (In-State) and Nonresident (Out-of-State) Pharmacies, Sterile Compounding Pharmacies, Wholesale Distributors, and Outsourcing Facilities

Table IV.2: The Number of States That Reported Conducting Different Types of Inspections for Resident (In-State) and Nonresident (Out-of-State) Pharmacies, and Other Entities

Table IV.3: Frequency of Recurring Inspections, by the Number of States That Reported Conducting Them

Table IV.4: The Number of States Reporting Challenges in Maintaining or Meeting Required Inspection Time Frames as Defined in Their State Laws, Regulations, or Policies

Table IV.5: Ways in Which States Reported Managing Inspections of Licensed or Registered Nonresident (Out-of-State) Pharmacies

Table IV.6: Types of Enforcement Actions States Reported They Can Take against Licensed or Registered Pharmacists or Pharmacies, by Reporting State

V. Communication and Interactions with the Food and Drug Administration

Table V.1: States That Reported Participating in FDA-Sponsored Activities Related to Drug Compounding, and How These States Rated the Helpfulness of Each Activity

Table V.2: The Number of States That Reported Obtaining Information Related to Drug Compounding from FDA’s Website, and How These States Rated the Helpfulness of This Information

Table V.3: The Number of States That Reported Having Entered into a Long-Term Drug Compounding Information Sharing Agreement with FDA, and How These States Rated the Effectiveness of the Agreement for Sharing Information Regarding Drug Compounding

Table V.4: The Number of States That Reported Having FDA Commissioned Officers, and How These States Rated the Effectiveness of Having Commissioned Officers for Sharing Information and Conducting Activities Related to Drug Compounding

Table V.5: The Number of States Reporting Challenges Regarding Communication or Interactions with the Food and Drug Administration (FDA) Related to Drug Compounding Issues

Table V.6: States Reporting Challenges in Communication or Other Interactions with FDA

Table V.7: The Number of States Reporting Each Level of Satisfaction with FDA Communication Regarding Drug Compounding

VI. Communication with Other States

Table VI.1: The Number of States Reporting Having Communication or Interactions with Pharmacy Regulatory Bodies in Other States Related to Drug Compounding Issues

Table VI.2: The Number of States That Reported Communication and Interactions with Other State Pharmacy Regulatory Bodies, and How These States Rated the Helpfulness of This Communication and Interaction

Table VI.3: The Number of States Reporting Each Level of Satisfaction with Communication and Interactions with Other State Pharmacy Regulatory Bodies Related to Drug Compounding

VII. Implementation of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

Table VII.1: How States Rated the Usefulness of Information on FDA’s Website Related to Drug Compounding, by Number of Reporting States

Table VII.2: The Number of States Reporting Hearing Concerns Regarding FDA’s Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act, as of January 1, 2016

(101168)

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