Why Is OTC Drug Compliance Necessary
The US Food and Drug Administration (FDA) reviews and subjects all over-the-counter (OTC) drugs to the highest level of safety and effectiveness before allowing companies to release the drug to the public as an OTC drug. The FDA conducts inspections globally, and companies need to be aware of FDA rules to avoid sanctions such as barring of products from the US market, recalls, and public “misbranding” warning letters. This is the case even with so-called “cosmeceuticals,” cosmetic products such as anti-perspirants or sunscreen lipsticks or “fresh breath” mouthwashes which are essentially cosmetic products, but with a claim and ingredients that put them into the “cosmeceutical” over-the-counter (OTC) category for purposes of FDA cGMP (good manufacturing practices for drugs).
Over-the-counter (non-prescription drugs) must remain drug compliant with a strict checks and balances system. The Division of Nonprescription Drug Products under the umbrella of the Food Drug and Cosmetic Act administered by the FDA ensures OTC drugs are compliant to written rules and regulations.
A branch of the FDA, the Office of Drug Evaluation, reviews all imports and all retail stores selling OTC drugs. This branch oversees drug development, reviews, investigates container labels for accuracy, researches consumer studies, and safety data of those drugs, and searches out any regulatory issues. All prescription and OTC drugs on the market are regulated by the FDA. Tens of thousands of OTC drugs are already present in the US market.
What is an OTC Drug Monograph?
An OTC drug monograph, considered part of drug compliance simply contains permissible indications for use (claims) and a recipe of active and often inactive ingredients of that drug. The monograph covers all of the acceptable claims, ingredients, dosing, formulas that make up that drug and the labeling of the drug container. It is the drugs monograph that sets the standard of safety for that medication and the overall effectiveness.
The Necessity For OTC Drug Compliance
Manufacturers, distributors, and importers, as well as relabelers, do not need premarket approval (a premarket license or registration involving official advance approval by the FDA) to sell OTC medications.
No drug is entirely safe, including OTC drugs. Users can experience adverse reactions and misuse OTC drugs. However, the FDA finds that the ingredients of OTC drugs are largely safe and effective if the consumer closely follows the instructions on the label.
These drugs are largely taken without the permission or advice of the doctor in the form of a prescription. Pharmaceutical companies expect consumers to take the responsibility for reading the label, know what the active ingredients include, the warnings, dosages, and directions for safe administration.
Can OTC Drug or “Cosmeceutical” Regulations Non-Compliance Cause Trouble?
Compliance of OTC drugs and cosmeceuticals by manufacturers, distributors, relabelers, and importers is vital because there are clear and present dangers when taking these drugs, including adulteration (in the case of non-compliance with FDA drug good manufacturing practices, cGMP). Taking too much of an OTC drug can cause a risk for addiction and possibly lead to additional health risks. Taking an OTC drug in contravention of its label can lead to adverse reactions. For this reason, the agency emphasized correct labeling and adverse reaction reporting as well as strict conformance with quality systems (cGMP) requirements and compliance with the relevant OTC monograph.
How to Minimize Human Errors in Drug Compliance
When an OTC drug product including a cosmeceutical is reviewed by the FDA, the drug is not scrutinized by one department and certainly not by one person. The drug is reviewed tirelessly by multiple branches of the FDA including onsite inspections. The safety and efficacy of the OTC drug and its compliance with the OTC monograph and FDA rules anre regulation are repeatedly evaluated and reevaluated after the drug enters the US market.
Why You Need an FDA OTC Drug Product Compliance Lawyer by Your Side
OTC drugs are complex products, even though they include everyday seemingly simple products like antiperspirants, sunscreens, anti-athlete’s-foot products, acne treatment preparations, toothpastes are more. An FDA-savvy compliance lawyer can assist you in complying with the web of FDA rules and regulations.