The Drug Quality and Security Act

Multistate outbreak of fungal meningitis and other infections – case count. Centers for Disease Control and Prevention. http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html. Accessed May 28, 2014.

Compounding quality act. Title I of the Drug Quality and Security Act of 2013. US Food and Drug Administration. http://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/. Accessed May 28, 2014.

Outterson K. The Drug Quality and Security Act – mind the gaps. N Engl J Med. 2014; 370(2): 97–99.

Goldman T.R. Regulating compounding pharmacies. A new law aims to fill the gaps in FDA inspection and enforcement of compounding pharmacies. Health Affairs. http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_114.pdf. Accessed May 28, 2014.

The Drug Quality and Security Act (H.R. 3204). Section 503B of the Food, Drug & Cosmetic Act. American Society of Health-System Pharmacists. http://www.ashp.org/DocLibrary/Advocacy/HR3204-Section503B.pdf. Accessed May 28, 2014.

Registered outsourcing facilities. US Food and Drug Administration. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm. Accessed May 28, 2014.

Drug Supply Chain Security Act (DSCSA). Title II of the Drug Quality and Security Act of 2013. US Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurity-Act/. Accessed May 28, 2014.