Sign In
The CEO Views Small logos
  • Home
  • Technology
    Artificial Intelligence
    Big Data
    Block Chain
    BYOD
    Cloud
    Cyber Security
    Data Center
    Digital Transformation
    Enterprise Mobility
    Enterprise Software
    IOT
    IT Services
    Innovation
  • Platforms
    How IBM Maximo Is Revolutionizing Asset Management
    How IBM Maximo Is Revolutionizing Asset Management
    IBM
    7 Min Read
    Optimizing Resources: Oracle DBA Support Services for Efficient Database Management
    Oracle
    Oracle
    9 Min Read
    The New Google Algorithm Update for 2021
    google algorithm update 2021
    Google
    5 Min Read
    Oracle Cloud Platform Now Validated for India Stack
    Service Partner Horizontal
    Oracle
    3 Min Read
    Oracle and AT&T Enter into Strategic Agreement
    oracle
    Oracle
    3 Min Read
    Check out more:
    • Google
    • HP
    • IBM
    • Oracle
  • Industry
    Banking & Insurance
    Biotech
    Construction
    Education
    Financial Services
    Healthcare
    Manufacturing
    Mining
    Public Sector
    Retail
    Telecom
    Utilities
    Gaming
    Legal
  • Functions
    RISMA Systems: A Comprehensive Approach to Governance, Risk and Compliance
    Risma Systems
    ENTREPRENEUR VIEWSGDPR
    9 Min Read
    Happiest Minds: A “Privacy by Design” approach is key to creating GDPR compliant businesses
    Happiest Minds 1
    GDPR
    8 Min Read
    Gemserv: GDPR 2020 and Beyond
    Gemserv 1
    GDPR
    9 Min Read
    ECCENCA:GDPR IS STILL AN UNTAMED ANIMAL
    eccenca 1
    GDPR
    6 Min Read
    Boldon James: HOW ENTERPRISES CAN MITIGATE THE GROWING THREATS OF DATA
    Boldon James 1
    GDPR
    8 Min Read
    Check out more:
    • GDPR
  • Magazines
  • Entrepreneurs Views
  • Editor’s Bucket
  • Press Release
  • Micro Blog
  • Events
Reading: Apprehending Over-the-Counter (OTC) Drugs and the Role of the FDA in Their Approval
Share
The CEO Views
Aa
  • Home
  • Magazines
  • Enterpreneurs Views
  • Editor’s Bucket
  • Press Release
  • Micro Blog
Search
  • World’s Best Magazines
  • Technology
    • Artificial Intelligence
    • Big Data
    • Block Chain
    • BYOD
    • Cloud
    • Cyber Security
    • Data Center
    • Digital Transformation
    • Enterprise Mobility
    • Enterprise Software
    • IOT
    • IT Services
  • Platforms
    • Google
    • HP
    • IBM
    • Oracle
  • Industry
    • Banking & Insurance
    • Biotech
    • Construction
    • Education
    • Financial Services
    • Healthcare
    • Manufacturing
    • Mining
    • Public Sector
    • Retail
    • Telecom
    • Utilities
  • Functions
    • GDPR
  • Magazines
  • Editor’s Bucket
  • Press Release
  • Micro Blog
Follow US
© 2022 Foxiz News Network. Ruby Design Company. All Rights Reserved.
The CEO Views > Blog > Editor's Bucket > Apprehending Over-the-Counter (OTC) Drugs and the Role of the FDA in Their Approval
Editor's Bucket

Apprehending Over-the-Counter (OTC) Drugs and the Role of the FDA in Their Approval

The CEO Views
Last updated: 2025/05/26 at 9:57 AM
The CEO Views
Share
FDA and OTC medicine regulation

Over-the-Counter Medicines: Tracing Back to a History

The history of ‘over-the-counter’ medicines has been no less than an uphill battle. The famous Rose case that led to the decision of the House of Lords in 1704 stated that apothecaries could prescribe and dispense medicines. This breaks the monopoly of the College of Physicians. Over time, this medicine type continued to be generally available in Britain until 1860, when prescription-only medicines came into play, keeping in mind the safety of drug usage.

The development of over-the-counter drugs in the USA has a history deeply rooted in the lack of regulation in the early stage, which evolved through various legislative changes and actions taken by the US Food and Drug Administration to ensure effectiveness and safety.

Initially, most of the drugs were available without a prescription, and the chances of selling potentially harmful substances as medicines were higher at that time. Gradually, with the Food, Drug, & Cosmetic (FD&C) Act of 1938 and subsequent amendments like the Durham-Humphreys Amendment of 1951, a framework was established to distinguish between OTC and prescription drugs.  

This small study by The CEO Views has explored and contributed to the understanding of OTC drugs and how the FDA (Food and Drug Administration) played a remarkable role in their development.

Understanding Over-the-Counter Medicines

As pronounced by the FDA (Food and Drug Administration), over-the-counter medicines (OTC) or nonprescription medicines can be bought without a prescription. These medicines are safe and effective to consume if one follows the directions on the label or as directed by one’s healthcare professional. These FDA drugs include pain relievers and fever reducers, and consumers can get details of their safe usage by going through the Food and Drug Administration‘s published brochures, articles, fact sheets, checklists, printed public service announcements, and other educational resources. 

OTC Drug Review Process and the Monograph System

Among all the FDA drugs, over-the-counter drugs have had a longer history of review and amendments. Nonprescription drugs can be brought to the US market through two regulatory pathways – the drug application process and the over-the-counter drug review, or the OTC drug monograph process.

On March 27, 2020, the CARES Act (the Coronavirus Aid, Relief, and Economic Security Act, P.L. 116-136) added section 505G to the Federal FD&C  Act. This Section reforms and advances the OTC monograph drugs regulation framework. Under Section 505G, OTC monograph drugs can be marketed without an approved drug application if they meet the regulatory requirements.

According to the FDA (Food and Drug Administration), the monograph system states certain conditions, such as uses, active ingredients, labelling, routes of administration, and testing, under which an over-the-counter drug in a given therapeutic category is generally recognized as safe and effective (GRASE) for use.

The process under Section 505G(b) states that the Food and Drug Administration has the authority to direct an administrative order, using which it can add, remove, or change (GRASE) conditions for an OTC drug monograph. 

Administrative Order Process

The administrative order process can either be initiated by an industry (drug development, processing, manufacturing, and marketing) or the FDA (Food and Drug Administration).

FDA-Launched Order

The FDA initiates a proposed order, for which the public is given at least 45 days to submit their feedback. After reviewing and considering their feedback, the Food and Drug Administration issues a final order, the final over-the-counter monograph. The final order is subject to an administrative hearing, dispute resolution, and judicial review.

Industry-Issued Order

In this review process, an industry can request the FDA to issue an administrative order by submitting an OTC monograph order request (OMOR). After review, the FDA will determine if the OMOR is acceptable for filing. If found acceptable, it will issue a proposed order. The latter processes are the same as the FDA-initiated administrative order issuing process.

Ensuring the Safety of OTC Products: An FDA Approach

The FDA (Food and Drug Administration) strives to ensure that over-the-counter drugs, like all other FDA drugs, are safe to consume. It has enforced regulations to ensure that OTC drugs are safe and the labels are easily understood by the users. To achieve that, all OTC products must meet FDA effectiveness, quality, and safety standards. Although they are easily obtained and do not require a prescription, they are medicines and have risks associated with them. Below are some of the safety standards issued by the Food and Drug Administration that one must consider before consuming OTC products- 

  • Just by using the labels on the over-the-counter products, consumers can be able to decide if the product is safe for them to use, understand warnings, and follow usage directions.
  • They must be FDA-approved to ensure they are safe and effective.

Examples of Some OTC Products Available in the Market

There are many over-the-counter products available in the market. These include-

  • Fever reducers
  • Pain relievers
  • Antiperspirants
  • Cough & cold medicines
  • Emergency contraceptives
  • Medicines for heartburn
  • Hair re-growth solutions
  • Weight loss medicine
  • Sunscreens
  • Toothpastes
The CEO Views May 26, 2025
Share this Article
Facebook Twitter LinkedIn Email Copy Link
Previous Article CEO reading business magazine CEO and Company Magazines: Unveiling the Benefits of Reading a Business Magazine
Next Article How Does Sensory Integration Therapy Improve a Child’s Daily Functioning How Does Sensory Integration Therapy Improve a Child’s Daily Functioning?
How to Ensure a Good User Experience for Your Business on Company Website

How to Ensure a Good User Experience for Your Business on Company Website

February 14, 2024
Kasia Borowska Managing Director Brainpool AI
ENTREPRENEUR VIEWS

AI in Construction

The CEO Views By The CEO Views September 12, 2024
Understanding eye health
Healthcare

Understanding eye health: Why it’s important to see an ophthalmologist

The CEO Views By The CEO Views June 30, 2025
VATIVORX
ENTREPRENEUR VIEWS

VATIVORX: Innovative and Tailored Pharmacy Benefit Management Providers

The CEO Views By The CEO Views February 28, 2024
LOCOMOBI WORLD INC
ENTREPRENEUR VIEWS

LOCOMOBI WORLD INC.: Building Modern Sustainable Cities

The CEO Views By The CEO Views February 27, 2024

How AI is Transforming the Video Production Industry

July 1, 2025

Breaking into the Luxury Market: How New Jewelry Brands Are Disrupting Legacy Players

June 30, 2025

The Power of Shopify Email Apps: A Simple Guide for Your Store

June 30, 2025

How Cannabis Dispensaries Improve Access and Convenience

June 30, 2025

You Might Also Like

us stocks rise oil falls iran missile attack
Editor's Bucket

The US Stock Market Today Takes a Surprising Turn as Stocks are Rising and Oil is Tumbling after Iran Launched Missiles at US Bases

6 Min Read
Business growth strategy
Editor's Bucket

6 Most Effective Business Expansion Strategies for Corporate Companies to Propel Growth in 2025

6 Min Read
Tech leader guiding a team
Editor's Bucket

Leadership in Technology: 10 Qualities and Skills that Every Tech Leader Must Have in 2025

7 Min Read
Best e commerce magazines
Editor's Bucket

15 Best E-Commerce Magazines and Publications that Contribute to E-commerce Business Growth

8 Min Read
Small logos Small logos

© 2025 All rights reserved. The CEO Views

  • About Us
  • Privacy Policy
  • Advertise with us
  • Reprints and Permissions
  • Business Magazines
  • Contact
Reading: Apprehending Over-the-Counter (OTC) Drugs and the Role of the FDA in Their Approval
Share

Removed from reading list

Undo
Welcome Back!

Sign in to your account

Lost your password?