What's New on the FDA Drugs Site
April 15, 2016
- FDA alerts health care professionals not to use sterile drug products from Pharmakon Pharmaceuticals, Inc., Noblesville, Indiana
- Drug Approval Package: Finacea (azelaic acid) Foam
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 244KB)
- FDA issues three new draft guidances related to compounding of human drugs
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Calcium Chloride Injection, USP (Updated - Currently in Shortage)
- Cefepime Injection (Updated - Currently in Shortage)
- Epinephrine Injection (Updated - Currently in Shortage)
- Imipenem and Cilastatin for Injection, USP (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection, USP, CII, (Preservative-Free)(For PCA Use Only) (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Vancomycin Hydrochloride for Injection, USP (Updated - Currently in Shortage)
- Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 82KB)
- National Drug Code Directory
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 296KB)
- Purple Book: CDER List of Licensed Biological Products (PDF -1MB) (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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