FDA

RESOURCES

PHARMACY COMPOUNDING
GENERAL
                                                                                                                       

FDA Compounding Home Page

2018 Compounding Policy Priorities Plan

Text of 503A (traditional pharmacy)

Text of Compounding Quality Act (503B outsourcing facility)

GUIDANCES FOR INDUSTRY
                                                                                  

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act​

Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application​

Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act​

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act​

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities​

Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act​

Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act​

Insanitary Conditions at Compounding Facilities​

Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act​

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

Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 

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

Final Regulation Deeming New Tobacco Products Subject to Food, Drug and Cosmetic Act (E-cigs, Cigars, Smokeless Tobacco, Roll-Your-Own)

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

Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops

Submission of Warning Plans for Cigars

Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers

Civil Money Penalties and NoTobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions

FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements

Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods

“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act

Meetings with Industry and Investigators on the Research and Development of Tobacco Products

Tobacco Product Master Files

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

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PHARMACY LAW COUNSEL

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© 2018 by Pharmacy Law Counsel LLP

DISCLAIMER

This site is not intended to be legal advice. Contacting the firm or reading the materials on the site does not create an attorney-client relationship. No confidential information should be sent over the internet. Past results do not predict future outcomes as each situation has to stand on its own. Melissa Gilmore is licensed to practice law in the District of Columbia, New York (inactive), and California (inactive). Donato J. Borrillo is licensed to practice law in Ohio.