Over-the-counter drugs

Stay Informed with Real-Time Monitoring of OTC Drug Regulations

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Why Monitoring Over-the-Counter Drugs Matters

Over-the-counter (OTC) drugs play a vital role in the healthcare system, providing accessible medication options to consumers without requiring a prescription. As the regulatory landscape around these medications evolves, it's crucial for various stakeholders to stay informed about new rules, compliance requirements, and funding opportunities.

Key Stakeholders and Their Interests

  1. Healthcare Providers and Pharmaceutical Companies

    • Compliance: Staying compliant with the latest FDA regulations is essential for pharmaceutical companies and healthcare providers to ensure the safety and efficacy of their products.
    • Innovation: Monitoring Federal Register announcements can reveal new funding opportunities for research into OTC drug innovation.

  2. Legal and Compliance Teams

    • Regulatory Alerts: Understanding the changing landscape of federal regulations helps avoid legal repercussions and ensures adherence to updated standards.
    • Responding to Comment Periods: Engage in open comment periods to influence future regulations and guidelines.

  3. Retailers and Distributors

    • Supply Chain Adjustments: Regulatory changes may impact supply chains, necessitating timely adaptations to maintain business operations smoothly.
    • Market Trends: By monitoring trends, retailers can adjust their product offerings to meet consumer demand effectively.

  4. Trade Associations

    • Advocacy and Lobbying: With up-to-date information, trade associations can better advocate for their members' interests and influence policy-making processes.

Recent Trends in OTC Drug Regulation

The OTC drug sector has experienced increased regulatory scrutiny due to rising concerns about drug safety, ingredient transparency, and mislabeling. Recent trends show a move towards stricter guidelines to enhance consumer safety and efficacy of these products. Regulatory bodies are pushing for more robust evidence of product effectiveness and clearer labeling standards.

How Monitoring Can Benefit You

Monitoring the Federal Register for updates on OTC drug regulations ensures you're always a step ahead. Understanding new regulations and compliance requirements prevents legal issues and helps seize opportunities as they arise.

The Power of AI in Monitoring

FedMonitor.com leverages AI technology to streamline the monitoring process—filtering through noise and delivering only the information that matters to you:

  • Relevance: Receive notifications on rules and notices relevant to your industry and interests.
  • Speed: Get real-time alerts delivered to your Slack channels, Microsoft Teams chats, or Salesforce integrations, ensuring you never miss an important update.
  • Ease of Use: Simplify your monitoring efforts with AI-driven analytics that highlight document relevance; easily comprehend even the most complex documents at a glance.

"Staying informed has never been easier. With FedMonitor.com, adapt quickly and efficiently to changes that impact your business."

To learn more about our AI-powered monitoring solutions, contact us today or explore our FAQ page to see how we can tailor fit the service for you. And don't miss out—sign up for a free trial now and transform the way you engage with regulatory updates.

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Latest Documents

Title Type Published
Health and Human Services Department > FDA, CMS, ACF
Regulatory Clean Up Initiative
The U.S Department of Health and Human Services (HHS) is amending its regulations to make miscellaneous corrections, including correcting references to other regulations, misspellings and other typographical errors. This document is necessary to info...
 Rule Nov 16, 2020
Health and Human Services Department > FDA
Sunscreen Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA propo...
 Proposed Rule Feb 26, 2019
Health and Human Services Department > FDA
Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and perform...
 Rule Nov 23, 2016
Health and Human Services Department > FDA
Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
The Food and Drug Administration (FDA or Agency) is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC...
 Proposed Rule Apr 04, 2016
Health and Human Services Department > FDA
Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph
The Food and Drug Administration (FDA or the Agency) is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinat...
 Proposed Rule Dec 23, 2015
Health and Human Services Department > FDA
Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment
The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and...
 Rule Nov 14, 2014
Health and Human Services Department > FDA
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic...
 Rule Jun 10, 2014
Health and Human Services Department > FDA
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record
The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish...
 Proposed Rule Dec 17, 2013
Health and Human Services Department > FDA
Labeling for Bronchodilators To Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an "Asthma alert") and to revise the indications, warnings, and directions in the la...
 Rule Jul 26, 2011
Health and Human Services Department > FDA
Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments
The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Readin...
 Rule Jun 01, 2011
Health and Human Services Department > FDA
Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph
The Food and Drug Administration (FDA) is issuing a proposed rulemaking to amend the tentative final monograph (1985 TFM) for over- the-counter (OTC) laxative drug products (products that relieve occasional constipation). FDA is proposing that sodium...
 Proposed Rule Feb 11, 2011
Health and Human Services Department > FDA
Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-The-Counter Human Use; Final Rule
We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this fina...
 Rule Mar 04, 2010
Health and Human Services Department > FDA
Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over-the-Counter Human Use; Technical Amendment
We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-the-counter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetra...
 Rule Mar 06, 2009
Health and Human Services Department > FDA
Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment
The Food and Drug Administration (FDA) is amending the regulation that establishes conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective (GRASE) and not misbranded. This amendment r...
 Rule Feb 01, 2008
Health and Human Services Department > FDA
Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph
The Food and Drug Administration (FDA) is issuing a proposed rule that would amend the final monograph (FM) for over-the-counter (OTC) sunscreen drug products as part of FDA's ongoing review of OTC drug products. This amendment addresses formulation,...
 Proposed Rule Aug 27, 2007
Health and Human Services Department > FDA
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling
The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labeling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include new warnin...
 Proposed Rule Dec 26, 2006
Health and Human Services Department > FDA
External Analgesic Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record and Amendment of Tentative Final Monograph
The Food and Drug Administration (FDA) is reopening the administrative record for the rulemaking for over-the-counter (OTC) external analgesic drug products to accept comments and data concerning OTC external analgesic drug products that have been fi...
 Proposed Rule Jul 17, 2003
Health and Human Services Department > FDA
Topical Antifungal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph
The Food and Drug Administration (FDA) is issuing a final rule amending the monograph for over-the-counter (OTC) topical antifungal drug products. The amendment makes a minor change in the indications for these drug products. This final rule is part...
 Rule Aug 29, 2000
Health and Human Services Department > FDA
Topical Otic Drug Products for Over-the-Counter Human Use; Products for Drying Water-Clogged Ears; Amendment of Monograph; Lift of Partial Stay of Effective Date
The Food and Drug Administration (FDA) is issuing a final rule amending the monograph for over-the-counter (OTC) topical otic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe a...
 Rule Aug 10, 2000
Health and Human Services Department > FDA
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for OTC Antitussive Drug Products
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antitussive drug products (products that relieve cough). Use of topical/inhalant products containing camphor or menthol near a flam...
 Rule Aug 01, 2000

Related Topics

O

Over Counter Drugs

L

Labeling

D

Drugs

R

Reporting & Recordkeeping Requirements

A

Administrative Practice & Procedure

M

Medical Devices