On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more
10/11/2024
/ Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Requirements ,
Supply Chain
On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more
8/30/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Requirements ,
Supply Chain
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
8/23/2023
/ Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
New Guidance ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements ,
Suppliers ,
Supply Chain ,
Waivers ,
Wholesale