GAO Survey of State Regulation of Drug Compounding Offers Mixed Results

Posted 31 March 2017 By Zachary Brennan

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Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use.

Building on a 2016 report, the new survey results released by the US Government Accountability Office on Friday on the state regulation of compounding and opinions on FDA interactions found 39 of 50 reported have conducted joint inspections with FDA of drug compounders, and 27 of 50 reported having commissioned officers with FDA.

Background

The Drug Quality and Security Act of 2013 helped clarify who oversees drug compounding nationally and created a new category of compounders called outsourcing facilities, which must register with and be inspected by FDA, among other requirements.

Conducted from 8 February 2016 through 15 April 2016, GAO’s survey collected information on each state pharmacy regulator and its oversight responsibilities for drug compounding; pharmacists, pharmacies, and drug compounding in each state; types of state laws, regulations and policies on drug compounding; inspections and enforcement actions; states' perspectives on interactions with FDA and other states, and any associated challenges; and states' perspectives on FDA's implementation of section 503A—with requirements for drug compounders that are not outsourcing facilities—and section 503B—the section for outsourcing facilities.

Findings

Although participation in FDA’s more recent advisory committees has waned among states, a majority of respondents found FDA’s online information to be useful.

In addition, 10 of 50 entered into what’s known as a 20.88 agreement with FDA, which allows FDA to share certain non-public information with state and local government officials.

To see more on what GAO released on Friday, check the tables below:

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

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

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

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

Communication and Interactions with FDA

 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

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

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

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Categories: Drugs, News, US, FDA

Tags: GAO, drug compounding, regulation of drug compounders

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