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Alabama Pharmacist Defense Lawyer – Board of Pharmacy Matter Pending? We Can Help – NACDS and APhA Urge Trump Administration to Reject Broad Drug Importation Proposals and HHS Waiver Authority – (866) 348-2889
The National Association of Chain Drug Stores (NACDS) and the American Pharmacists Association (APhA) urge the Trump Administration to refrain from endorsing pending legislative proposals that would allow for broad personal and commercial importation of non-FDA-approved prescription drugs. In a letter, NACDS and APhA also ask the Secretary of Health and Human Services (HHS) to not exercise the waiver authority that allows the Secretary to waive the general prohibition against personal importation of prescription drugs.
The Drug Supply Chain Security Act (DSCSA), which requires the track and trace of prescription drugs from manufacturer to receipt by the dispenser, is undermined by drug importation, notes the letter. Importation proposals fail to align with track and trace requirements of the DSCSA in addition to other DSCSA requirements involving licensure of supply chain participants, verification and validation of drug products, and the handling of suspect and illegitimate products. The letter states, “broad importation and HHS waiver of importation prohibitions create loopholes within the DSCSA regulatory framework, easily allowing counterfeit drugs to slip into the United States supply chain.