News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Federal Register

Stevens & Lee

FDA Guidance on Drug Compounding for Veterinarians and Pharmacists

Stevens & Lee on

The Guidance published in the Federal Register last April for “veterinarians, State-licensed pharmacies, and Federal facilities” regarding compounding animal pharmaceuticals will take effect April 2023. The guidance focuses...more

King & Spalding

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

King & Spalding on

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more

Troutman Pepper

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

Troutman Pepper on

The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

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