The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more
1/11/2024
/ Department of Health and Human Services (HHS) ,
DQSA ,
Draft Guidance ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Interim Guidance ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Section 503
The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more
9/1/2023
/ Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
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
Last week the Supreme Court ("the Court") released a decision holding that the Federal Controlled Substance Act (the "Act") provision that criminalizes the dispensing of a controlled substance “except as authorized” includes...more
7/5/2022
/ 21 U.S.C. § 841 ,
Controlled Substances ,
Controlled Substances Act ,
Criminal Liability ,
DEA ,
Food & Drug Regulations ,
Health Care Providers ,
Healthcare ,
Intent ,
Jury Instructions ,
Mens Rea ,
Opioid ,
Pharmaceutical Industry ,
Prescribing Authority ,
Prescription Drugs ,
Reasonable Doubt ,
Ruan v United States ,
SCOTUS ,
Statutory Violations ,
Subjective Standard