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Pharmaceutical Regulation and Safety

Pharmaceutical Regulation and Safety

Pharmacy

THE DRUG QUALITY & SECURITY ACT

Pill Bottle On Nov. 27, 2013, President Obama signed into law the Drug Quality and Security Act [Public Law 113-54]. The Food and Drug Administration has begun implementation of the new law with a release guidance addressing pharmaceutical compounding.

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DRUG SHORTAGES: PRESERVING THE DRUG SUPPLY

Perscription and pen beside stethescopeAlthough there were fewer reported drug shortages in 2012, the FDA continues to see shortages involving older sterile injectable drugs. Find out how this problem may affect the public's health and the provisions of health care across the country, and what's being done by the FDA to mitigate the problem.

 

 

 

 

 

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OVERVIEW

Ensuring the safety and quality of the nations’ drug supply is a collaborative effort between state and federal governments. Historically the regulation of pharmacies and pharmaceutical practice has been under state authority, but emerging market practices and lack of quality standardization justify changes to the traditional regulatory system.  Cost and pharmaceutical supply shortages have given rise to consumers seeking alternative sources, via Internet pharmacies or through foreign sources, for prescription needs.  Drug shortages have left widely used medications in critically short supply and impacted the ability of health care providers to offer certain treatments. Privacy requirements have required states to develop interoperability standards to inform and facilitate the exchange of prescription drug information across state lines. 

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NCSL Summit Resources

FEATURED

  • Oversight of the U.S. Drug Supply

    H.R. 3204 was approved by the U.S. Senate Nov. 18 and moves forward to the president's desk. The measure preempts state drug pedigree laws among other changes to the oversight of the pharmaceutical industry.

  • Drug Shortages: Preserving the Drug Supply

    The FDA has released their strategic plan to face the challenges of the drug shortages in the U.S., followed by a release of proposed rules requiring manufacturer reporting.

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