Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting
The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014.
DQSA-Related Rules
Several are related to FDA's new authority under the Drug Quality and Security Act (DQSA) of 2013, which contains numerous provisions intended to enhance FDA's ability to regulate compounding pharmacies. For example, FDA plans to issue proposed rules related to good manufacturing practices at outsourcing facilities (planned release: November 2014), and drug compounding differences between 503A and 503B facilities (planned release: October 2014).
Another DQSA regulation is an FDA proposal to make it easier to destroy low-value drugs that are refused admission into the US, such as those believed to be counterfeit or adulterated. That proposal was released in May 2014.
Yet another DQSA regulatory proposal would establish national standards for licensing prescription drug wholesale distributors and third-party logistics providers, and would also set up a federal licensing system to be used in the event that a state system does not meet federal standards. The proposal is set to be released in November 2013, with the final rule due no later than November 2015.
A fifth proposed rule would establish a list of drug products that would not be able to be compounded by a pharmacy by virtue of their having been removed or withdrawn from the market for reasons of safety or efficacy, either in whole or in part. That proposed rule is set to be released by the end of May 2014.
Non-DQSA Rule Proposals
Two rules appear to be unrelated to the DQSA, however.
One would "revise the requirements concerning annual reports submitted to investigational new drug applications (INDs) by replacing the current annual reporting requirement" with one endorsed by the International Conference on Harmonisation (ICH), similar to what FDA has done with ICH's E2C postmarket reporting standard. (Planned release date: March 2015)
The second proposed rule would restrict tanning beds and tanning lamps, though FDA did not elaborate on the broader intent of the rule. FDA has previously called for new labeling requirements for tanning beds, though this proposed rule appears to be different than that proposal.
| Rule Stage | Rule Title | RIN | New Rule? |
|---|---|---|---|
| Proposed Rule Stage | Investigational New Drug Application Annual Reporting | 0910-AH07 | NEW |
| Proposed Rule Stage | Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | 0910-AH08 | NEW |
| Proposed Rule Stage | Current Good Manufacturing Practice for Outsourcing Facilities | 0910-AH09 | NEW |
| Proposed Rule Stage | Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act | 0910-AH10 | NEW |
| Proposed Rule Stage | National Standards for Licensing of Prescription Drug Wholesale Distributor and Third-Party Logistics Providers | 0910-AH11 | NEW |
| Proposed Rule Stage | Administrative Destruction of Certain Drugs Refused Admission to the United States | 0910-AH12 | NEW |
| Proposed Rule Stage | General and Plastic Surgery Devices: Restriction of Sunlamp Products | 0910-AH14 | NEW |
| Prerule Stage | FDA Food Safety Modernization Act (FSMA) Amendments to Reportable Food Registry (RFR Requirements) | 0910-AG97 | NEW |
| Proposed Rule Stage | Food Labeling; Revision of the Nutrition and Supplement Facts Labels | 0910-AF22 | - |
| Proposed Rule Stage | Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs | 0910-AF23 | - |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products | 0910-AF31 | - |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Internal Analgesic Products | 0910-AF36 | - |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Oral Health Care Products | 0910-AF40 | - |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Sunscreen Products | 0910-AF43 | - |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products | 0910-AF69 | - |
| Proposed Rule Stage | Abbreviated New Drug Applications and 505(b)(2) | 0910-AF97 | - |
| Proposed Rule Stage | Updated Standards for Labeling of Pet Food | 0910-AG09 | - |
| Proposed Rule Stage | Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals | 0910-AG10 | - |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products | 0910-AG12 | - |
| Proposed Rule Stage | Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products | 0910-AG18 | - |
| Proposed Rule Stage | Sunlamp Products; Proposed Amendment to the Performance Standard | 0910-AG30 | - |
| Proposed Rule Stage | Produce Safety Regulation | 0910-AG35 | - |
| Proposed Rule Stage | Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food | 0910-AG36 | - |
| Proposed Rule Stage | "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act | 0910-AG38 | - |
| Proposed Rule Stage | Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals | 0910-AG45 | - |
| Proposed Rule Stage | Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives | 0910-AG59 | - |
| Proposed Rule Stage | Foreign Supplier Verification Program | 0910-AG64 | - |
| Proposed Rule Stage | Registration of Food Facilities: Amendments to Food Facility Registration Requirements | 0910-AG69 | - |
| Proposed Rule Stage | Establishment Registration and Product Listing for Tobacco Products | 0910-AG89 | - |
| Proposed Rule Stage | Pediatric Study Plan Requirements for New Drug and Biologics License Applications | 0910-AG93 | - |
| Proposed Rule Stage | Format and Content of Reports Intended to Demonstrate Substantial Equivalence | 0910-AG96 | - |
| Proposed Rule Stage | Sanitary Transportation of Human and Animal Food | 0910-AG98 | - |
| Proposed Rule Stage | Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods | 0910-AH00 | - |
| Proposed Rule Stage | Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves | 0910-AH02 | - |
| Proposed Rule Stage | Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System | 0910-AH03 | - |
| Proposed Rule Stage | Mammography Quality Standards Act; Regulatory Amendments | 0910-AH04 | - |
| Proposed Rule Stage | Investigational Tobacco Product Applications and General Information Regarding Submission of Information to Support Legal Marketing | 0910-AH06 | - |
| Final Rule Stage | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs | 0910-AA49 | - |
| Final Rule Stage | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling | 0910-AF11 | - |
| Final Rule Stage | Combinations of Bronchodilators With Nasal Decongestants or Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use | 0910-AF33 | - |
| Final Rule Stage | Over-the-Counter (OTC) Drug Review--Laxative Drug Products | 0910-AF38 | - |
| Final Rule Stage | Postmarket Safety Reporting for Combination Products | 0910-AF82 | - |
| Final Rule Stage | Laser Products; Amendment to Performance Standard | 0910-AF87 | - |
| Final Rule Stage | Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements | 0910-AF96 | - |
| Final Rule Stage | Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices | 0910-AG48 | - |
| Final Rule Stage | Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines | 0910-AG56 | - |
| Final Rule Stage | Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments | 0910-AG57 | - |
| Final Rule Stage | Use of Certain Symbols in Labeling | 0910-AG74 | - |
| Final Rule Stage | Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products | 0910-AG81 | - |
| Final Rule Stage | Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) | 0910-AG88 | - |
| Final Rule Stage | Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health Under the Food and Drug Administration Safety and Innovation Act | 0910-AG92 | - |
| Final Rule Stage | Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products | 0910-AG94 | - |
| Final Rule Stage | Veterinary Feed Directive | 0910-AG95 | - |