• Regulatory Revolution: FDA's Modernization of the OTC Drug Monograph System
    Blog - Prevention & Wellness

    Regulatory Revolution: FDA’s Modernization of the OTC Drug Monograph System

    September 27, 2025 - By 

    Introduction Over-the-counter (OTC) medications provide millions of Americans with accessible, affordable treatment options for common ailments without the need for a prescription. The regulatory framework that governs these medications—the OTC drug monograph system—has historically ensured safety and efficacy through a standardized review process. However, as consumer needs evolve and scientific advancements accelerate, this decades-old system has faced growing criticism for its complexity, slow pace, and inability to keep up with innovation. In response, the U.S. Food and Drug Administration (FDA) has embarked on a major regulatory modernization effort under the CARES Act, aiming to revamp the OTC drug monograph system.…

  • Store Brand vs. Name Brand: The Truth About OTC Medication Quality and Value
    Blog - Prevention & Wellness

    Store Brand vs. Name Brand: The Truth About OTC Medication Quality and Value

    September 27, 2025 - By 

    Introduction Walk down any pharmacy aisle, and you’ll see a familiar dilemma: name brand versus store brand over-the-counter (OTC) medications. One bottle of ibuprofen might cost twice as much as another—yet both claim the same dosage, ingredients, and purpose. For many consumers, this raises the question: Are store-brand OTCs really as effective and safe as their name-brand counterparts? Understanding the regulatory standards, quality assurance processes, and the economics behind OTC medications can help demystify these choices and empower smarter, more cost-effective decisions. FDA Bioequivalence Requirements for Generic OTCs For a generic (or store brand) OTC medication to be sold legally…

  • The Great Decongestant Debate: Why FDA Experts Say Oral Phenylephrine Doesn't Work
    Blog - Diseases & Conditions - Health Issues

    The Great Decongestant Debate: Why FDA Experts Say Oral Phenylephrine Doesn’t Work

    September 25, 2025 - By 

    Introduction For decades, phenylephrine has been a common ingredient in over-the-counter (OTC) cold and allergy medications marketed as effective nasal decongestants. Found in popular brands like Sudafed PE, DayQuil, and Tylenol Sinus, oral phenylephrine was widely assumed to relieve nasal congestion by shrinking blood vessels in the nasal passages. However, in a dramatic turn of events, experts from the U.S. Food and Drug Administration (FDA) have declared that oral phenylephrine is ineffective when taken at the recommended dose. This revelation has sparked national attention, consumer confusion, and calls for reform in how cold medications are regulated. The FDA’s Nonprescription Drugs…