Month: September 2024

FIRST AID ANTISEPTICS REGULATION

First aid antiseptics are regulated by the FDA as over the counter (OTC) drugs. The regulation falls under the FDA’s Over-the-Counter Monograph M003, which outlines specific requirements for labeling, active ingredients, testing and formulation.

The most common antiseptics include alcohol (ethanol, isopropyl), hydrogen peroxide, iodine, menthol, and benzalkonium chloride. Each active ingredient has specific concentration limits and efficacy standards. Based on the monograph permitted combinations of active ingredients are allowed with proper labeling requirements.

Products must comply with drug labeling requirements which include usage instructions, indications, warnings, and other required information. All claims must be supported by evidence.

Manufacturers must ensure their products are safe and effective for their intended use, by following good manufacturing practices (GMP).

Products that comply with the FDA monographs can be marketed without pre-approval. Those that do not comply must undergo the New Drug Application (NDA) process.

First aid antiseptic manufactures must comply with establishment registration and drug listing requirements as well.

Liberty Management Group, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

FDA ACNE REGULATIONS

USFDA regulates acne products and treatments under drugs, cosmetics, and medical devices.

Acne Drug Products

  • OTC Monograph Compliance: OTC acne treatments products must comply with the FDA’s ” Topical Acne Drug Products for Over-the-Counter Human Use ” (Monograph ID:  M006). This monograph specifies the active ingredients, dosage forms, labeling, and conditions under which these products can be marketed without a prescription.
  • Active Ingredients: Commonly used active ingredients in OTC acne products include benzoyl peroxide, salicylic acid, and sulfur. Each active ingredient has specified concentration ranges and usage guidelines.
  • Labeling Requirements: The FDA mandates specific labeling for OTC acne products, including indications for use (e.g., “for the “management/treatment of acne”), directions, warnings, and any potential adverse effects.
  • New Ingredients: If an acne product contains an active ingredient which is not FDA’s OTC monograph, then it must go through the New Drug Application (NDA) process to be approved.
  • cGMP compliance: All acne products must be manufactured in compliance with cGMP regulations.

Acne Treatment Medical devices

  • Device Classification: Acne treatment devices (e.g., light therapy devices) are classified into Class I, Class II or PMA devices based on their risk to patients. Most acne devices fall under Class II, which requires 510K clearance by proving that the device is substantially equivalent to a legally marketed device.

Cosmetic Acne Products

  • Definition: If a product is marketed as a cosmetic (e.g., cleansers, toners, or non-active ingredient-based products claiming to “reduce the appearance of acne”), it is not subject to the same requirements as drugs or devices. However, it must still be safe to use and properly labeled.
  • Label Claims: Cosmetic products must not make drug claims on the labels.

Liberty Management Group, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us