Drug Compounding:

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

GAO-17-363SP: Published: Mar 31, 2017. Publicly Released: Mar 31, 2017.

Additional Materials:

Contact:

Marcia G. Crosse
(202) 512-7114
crossem@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

This is a companion to our report, Drug Compounding: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges, GAO-17-64.

States oversee drug compounding, which creates drugs tailored for individual patients; the Food and Drug Administration also oversees this practice at the federal level.

We surveyed the state pharmacy regulatory bodies in the 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands on drug compounding. This e-supplement provides selected survey results, including data not in the report.

Pharmacist Compounding

Photo of pharmacist, wearing a mask and gloves, pouring red liquid into a glass beaker.

Photo of pharmacist, wearing a mask and gloves, pouring red liquid into a glass beaker.

Additional Materials:

Contact:

Marcia G. Crosse
(202) 512-7114
crossem@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

This e-supplement is a companion to GAO's report, GAO-17-64. The purpose of this e-supplement is to provide selected results of GAO's survey of state pharmacy regulatory bodies on drug compounding, including additional data that are not included in the report. GAO surveyed the 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 as part of the work for GAO's drug compounding report, and all but 4 states completed the survey. GAO's 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.

For more information, contact Marcia Crosse at (202) 512-7114 or crossem@gao.gov.

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