Month: August 2024

SUNSCREEN REGISTRATION

Sunscreen products are regulated by the FDA as over the counter (OTC) drugs. So, manufacturers must comply with drug regulations and guidelines to ensure their products are safe and effective for consumers.

Steps involved in Sunscreen registration are

  1. Monograph Compliance:
    • Sunscreens products must comply with the FDA’s OTC sunscreen monograph, which outlines the active ingredients, labeling, and testing requirements.
    • The current FDA-approved active ingredients for sunscreens include substances like zinc oxide, titanium dioxide, avobenzone, and others.
    • Products that adhere to OTC monograph do not require FDA pre-approval but must follow all regulations.
  2. Establishment Registration:
    • Manufacturers, packers, or distributors of sunscreen products must register their establishment with the FDA.
  3. Product Listing:
    • Once establishment is registered, the manufacturer must list the sunscreen products with the FDA with NDC number.
    • Drug listing includes all the active and inactive ingredients, drug facts label along with labels.
  4. Labeling Requirements:
    • Sunscreens must be labeled according to FDA regulations. This includes information on SPF water resistance, and appropriate usage directions.
    • Warnings and directions must be included to ensure proper use of the product and to minimize risks.
  5. Good Manufacturing Practices (GMPs):
    • Sunscreen products must be manufactured in compliance with Good Manufacturing Practices (GMPs) to ensure product quality and safety.
  6. Testing Requirements:
    • Sunscreens must undergo specific testing to substantiate their SPF claims and water resistance. The results of these tests must be documented and available for FDA review in case of inspection.
  7. Adverse Event Reporting:
    • Manufacturers must report any adverse events related to their sunscreen products to the FDA. This helps the FDA monitor the safety of sunscreens on the market.

Liberty Management Group , as a leading FDA consultant with provide assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us

HAND SANITIZER REGULATION

The FDA (Food and Drug Administration) regulates hand sanitizers to ensure they are safe and effective for consumer use even though it is considered as cosmetics in some foreign countries.

The FDA recognizes ethanol or ethyl alcohol (60% to 95 %) and isopropyl alcohol (70% to 91.3 %) as safe and effective to be used as an active ingredient in hand sanitizers. Benzalkonium chloride is another active ingredient considered safe and effective, though less effective than alcohol-based sanitizers against certain germs.

FDA consider hand sanitizers as OTC drugs and must comply with below requirements.

  • Submit drug listing with unique 10-digit NDC number for each hand sanitizer after FDA assign labeler code to the company.
  • Label Compliance – Antiseptic hand sanitizer must have “Drug Facts” labeling and all other required information like usage, directions, and warnings.
  • Comply with GMP Requirements as per 21 CFR 211 – Hand Sanitizer GMP which requires testing to ensure that the products are free from contamination and impurities.

Manufacturers that continue to make hand sanitizer products as of December 31, 2024, will be identified as OTC monograph drug facilities and be subject to an OMUFA facility fee for FY 2025 whereas if a company stopped the manufacturing process of hand sanitizers and deregister and de-lists their products before December 31st ,2024 will not be subject to FY 2025 OMUFA fee.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us