United States: Drug Quality and Security Act

On 27 November 2013, President of the United States, Barack Obama signed the Drug Quality and Security Act, a new law to safeguard the U.S. pharmaceutical supply from counterfeit and contaminated drugs.

- The Drug Quality and Security Act amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements.

- Drug Supply Chain Security Act establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain.

Read the Drug Quality and Security Act (Library of congress):

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