FDA
RESOURCES
PHARMACY COMPOUNDING
GENERAL
2018 Compounding Policy Priorities Plan
Text of 503A (traditional pharmacy)
Text of Compounding Quality Act (503B outsourcing facility)
GUIDANCES FOR INDUSTRY
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Insanitary Conditions at Compounding Facilities
Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act
Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Questions and Answers Related to Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [STATE] and the U.S. Food and Drug Administration
DIETARY SUPPLEMENTS
GENERAL
FDA Dietary Supplements Home Page
GUIDANCES FOR INDUSTRY
Highly Concentrated Caffeine in Dietary Supplements
Distinguishing Liquid Dietary Supplements from Beverages
Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide
MEDICAL DEVICES
GENERAL
FDA Medical Device Home Page
CFR Title 21 – Food and Drugs
MEDICAL DEVICE DATABASES
Access GUDID (Global Unique Device Identification Database)
Advisory Committee/Panel Meetings – CDRH
CDRH Inspections Database
De Novo
FDA Certified Mammography Facilities
Humanitarian Device Exemption (HDE)
IVD Home Use Lab Tests (Over The Counter) Tests
MAUDE (Manufacturer and User Facility Device Experience)
MDR (Medical Device Reporting)
Premarket Approvals (PMA)
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
Premarket Notifications (510(k)s)
Product Classification
Radiation-emitting Electronic Product Codes
Radiation Emitting Product Corrective Actions and Recalls
Recalls of Medical Devices
Registration & Listing
Total Product Life Cycle (TPLC)
FDA Recognized Consensus Standards
X-Ray Assembler Data
GUIDANCES FOR INDUSTRY
Manufacturing Site Change Supplements: Content and Submission
General Considerations for Animal Studies for Medical Devices
Unique Device Identification: Direct Marking of Devices
Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015
Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States
Current Good Manufacturing Practice Requirements for Combination Products
General Wellness: Policy for Low Risk Devices
Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers
Refuse to Accept Policy for 510(k)s
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex
Design Considerations for Devices Intended for Home Use
Distinguishing Medical Device Recalls from Medical Device Enhancements
COSMETICS & ANTI-AGING
FDA Cosmetics Home Page
Regulations Related to Cosmetics, Title 21, Code of Federal Regulations
Cosmetic Labeling Guide: Product Labels and Advertising Rules
Draft Guidance for Industry: Cosmetic Good Manufacturing Practices
Cosmetics Registration Program (VCRP)
Fact Sheet for Small and Home-Based Businesses
Fact Sheet for Importers & Exporters
Cosmetics Compliance Program: Import and Domestic – Guidance Manual Chapter 29
GENERAL
TOBACCO & E-CIGARETTES
GENERAL
FDA Tobacco & Vaping Home Page
DEEMING RULE
GUIDANCES FOR INDUSTRY
Listing of Ingredients in Tobacco Products
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule
Health Document Submission Requirements for Tobacco Products
The Prohibition of Distributing Free Samples of Tobacco Products
Compliance Policy for Required Warning Statements on Small-Packaged Cigars
Submission of Warning Plans for Cigars
Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers
Meetings with Industry and Investigators on the Research and Development of Tobacco Products
VETERINARY & ANIMAL
GUIDANCES FOR INDUSTRY
Guidance for Industry Compounding Animal Drugs from Bulk Drug Substances
COMPLIANCE
List of Registered Outsourcing Facilities
Compounding Pharmacies: Inspections, Recalls, and other Actions
FDA Center for Veterinary Medicine Home Page
Animal Feed
Pet Food
Animal Drugs
Unapproved Animal Drugs
Judicious Use of Antimicrobials
CLINICAL LABORATORIES
GENERAL
Clinical Laboratory Improvement Amendments (CLIA)
CLIA Currently Waived Analytes