fda registration drug

WART REMOVER REGULATION

Warts are noncancerous growths on the skin or mucous membranes caused by the human papillomavirus (HPV).

Salicylic acid is the only FDA approved active ingredient at concentrations between 5% and 40% subject to the delivery base like plaster/collodion-like or karaya gum, glycol plaster vehicle.

Since wart removers are considered as OTC drugs, the manufacturers must comply with all drug requirements such as establishment registration, drug listings, cGMP requirements and labeling.

In the labeling, they must include “Wart remover” along with the established name of the drug.

The labels must carry the indications of use, direction of use, warnings and contact phone numbers to call.

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

http://www.fdahelp.us

ANTIPERSPIRANT DRUG FDA REGULATIONS

US FDA regulates Antiperspirants as OTC drugs because of their active ingredients block sweat glands. On the contrary deodorants are considered as cosmetics and mainly intended to mask the body odor.

As per FDA’s OTC Drug Monograph for antiperspirants (M019), these products must follow FDA regulations to follow safety and effectiveness.

Active Ingredients: Only certain aluminum-based compounds are permitted, such as aluminum chloride, aluminum chlorohydrate, and various aluminum zirconium salts, with concentration limits ranging from 15% to 25% depending on the compound.

Labeling: Principal display panel must be marked as “antiperspirants” and include specific usage directions, such as “apply to underarms only,” and warnings like “Do not use on broken skin” and “Stop use if rash or irritation occurs”

Finished dosage form of antiperspirants may vary in effectiveness because of difference in formulation. Manufacturers must follow FDA’s guidelines to make sure the effectiveness of the antiperspirant.

Since antiperspirants are considered as OTC drugs, the manufacturer must comply with all drug requirements such as establishment registration, drug listing and labeling requirements.

Also, the manufacturers and contract manufacturers must pay OMUFA fee every year.

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.us

SUNSCREEN REGULATIONS

As per US FDA regulations, sunscreens are considered as over the counter drugs. Sunscreen manufacturers must comply with all US FDA drug regulations such as establishment registration, cGMP regulations, drug listing and label compliance.

As per drug regulations, the manufacturers must renew their registration between October 1^st and December 31^st every year and submit blanket listing submission as well.

Since Sunscreen products are considered as drug, the manufacturer must pay OMUFA fee also.

Active Ingredients

US FDA has permitted 16 active ingredients used in sunscreens:

Zinc oxide and titanium dioxide are considered as safe (GRASE – Generally Recognized as Safe and Effective)
Because of safety concerns PABA and trolamine salicylate are not considered safe.
For twelve other ingredients, including oxybenzone and avobenzone, FDA has requested additional safety data from manufacturers.

Dosage Forms

The FDA proposed that certain sunscreen forms be considered GRASE:

Dosage forms such asSprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks are considered as GRASE.
Whereas Wipes, towelettes, body washes, and shampoos are considered as Non GRASE, which require FDA approval before marketing.

Sun Protection Factor (SPF) and Broad-Spectrum Requirements

SPF Labeling: Proposed to raise the maximum labeled SPF value from 50+ to 60+, while allowing formulations up to SPF 80 to account for testing variability.
Broad-Spectrum Protection: Sunscreens with SPF 15 or higher would be required to provide broad-spectrum protection, meaning they must protect against both UVA and UVB radiation.

Labeling and Expiration Dates

The FDA proposed clearer labeling requirements to help consumers identify key product information. All OTC drug products, including sunscreens, must have an expiration date unless stability testing shows they remain stable for at least three years.

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

OMUFA FY 2025

OMUFA for FY 2025 gives out fees for facilities and OTC Monograph Order Requests (OMORs), in effect from October 1, 2024, through September 30, 2025.

OTC Monograph Drug facilities registered with FDA from January 1, 2024, through December 31, 2024, are liable for the FY 2025 FDA fees.

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2025

Type of Registration / Application	MDF Facility	CMO Facility
OTC Monograph Drug Facility Fee (OMUFA)	$37,556	$25,037

The above fees are applicable to the establishment manufacture or processing the finished dosage form of an OTC drug.

This fee must be paid by Monday June 2^nd, 2025.

Payment is due within twenty calendar days of the original due date, and it must be paid in US dollars either by electronic check or wire transfer.

Applicable wire transfer fees must be included with payment to ensure fees are fully paid.

The consequences of arrear payments are as below.

The facility will be placed on the arrears list.
OTC drug manufactured in such facilities will be considered misbranded and the company will be placed FDA’s arrears list.
An OMOR submitted by a person subject to fees shall be considered incomplete and not be accepted for filing until all fees owed by such person have been paid.
A person subject to fees shall be considered ineligible for OTC monograph drug meetings until they have paid the fees.

Liberty Management Group Ltd, a leading FDA consulting group provides assistance with OMUFA PIN creation, API drug establishment registration, Drug establishment registration and listing renewals and US agent service to foreign countries.

Sudha S

Regulatory Consultant

Email: Office@libertymanagment.us

www.fdahelp.us

OMUFA OVERVIEW

According to CARES Act, the Over-the-Counter Monograph Drug User Fee Program (OMUFA) is a program implemented by the U.S. Food and Drug Administration (FDA) to help fund the regulation of over the counter (OTC) drug products. The program aims to expedite the review and approval process for OTC drugs and improve the safety and availability of OTC products.

OMUFA’s goal is to provide the FDA with the necessary resources to evaluate, approve, and regulate new or modified OTC drug products more efficiently. It helps cover the costs of the FDA’s review activities, which are critical to ensuring the safety and effectiveness of OTC medications.

FDA has introduced two types of fees.

Establishment/Facility fees
OTC Monograph Order Request (OMOR) fees

Companies that wish to introduce a new OTC drug or update existing OTC monographs must pay user fees to the FDA.

OTC drugs are that products that fall under FDA’s OTC monograph which does not require FDA approval and can be marketed without a prescription. OMUFA was created to support the process of revising the monographs and reviewing drug products.

Manufacturers can submit new OTC drug products or requests for changes to the FDA’s existing monographs. These submissions are subject to review, and manufacturers must pay the applicable user fees.

OTC monograph drug facility (MDF) is a foreign or domestic establishment that is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.

A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliated partner or the establishment sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2025

Type of Registration / Application	MDF Facility	CMO Facility
OTC Monograph Drug Facility Fee	$37,556	$25,037

The following are the facilities that does not need to pay OMUFA for FY 2025.

API manufacturer of OTC monograph drug
OTC monograph drug facilities that had stopped all activities related to OTC monograph drugs prior to December 31, 2023, and had de-registered and de-listed their drugs.
Drug establishment registered during pandemic period whose sole activity with respect to OTC monograph drugs consisted of manufacturing OTC hand sanitizer products and has stopped manufacturing hand sanitizer products and delisted and deregistered with the FDA on or before on December 31, 2024.
Animal Drug manufacturers
Homeopathic drug manufacturers.

Sudha S

Regulatory Consultatnt

Email : office@libertymanagement.us

www.fdahelp.us

HAND SANITIZERS

Hand Sanitizers are regulated as over the counter (OTC) drug products by FDA.

US FDA has specific regulations to ensure their safety, effectiveness, and quality.

Below is an overview of key FDA regulations.

1. Active Ingredients:

FDA approved Hand Sanitizer active ingredients are as follows:

Ethanol (ethyl alcohol) – typically in concentrations of 60% to 95%.
Isopropyl alcohol – also commonly used at concentrations around 60% to 91%.
Non-Alcohol active ingredient Benzalkonium chloride 0.1 to 0.13%., but alcohol-based hand sanitizers are the most common and effective.

2. Labeling Requirements:

Hand sanitizer products must comply with FDA drug labeling requirements which include:

The active ingredient and its concentration.
Directions for use (e.g., amount to use and when to use).
Warnings (e.g., avoid contact with eyes, keep out of reach of children).
Inactive ingredients, if applicable.
Expiration date for the product if it has one.
Drug facts label if it is marketed as an OTC product.

3. Manufacturing Standards:

Hand Sanitizer manufacturers must comply with FDA GMP quality standards in manufacturing the drug.

4. Compliance with the Registration and Drug listing process:

Since Hand Sanitizers are considered as OTC drugs, the manufacturer must comply with drug establishment registration and drug listing process.

5. Banned Ingredients or Contaminants:

There are certain ingredients that the FDA has banned in manufacturing hand sanitizers. The list of ingredients can be found at https://www.fdahelp.us/fda-registration-hand-sanitiszer.html .

6. Enforcement and Recalls:

The FDA will issue recalls for hand sanitizers that do not comply with regulations, especially if they are found to be contaminated or ineffective. They also monitor the market for false or misleading claims (e.g., claiming to kill 100% of germs or other unproven health claims).

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

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

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

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.
Establishment Registration:
- Manufacturers, packers, or distributors of sunscreen products must register their establishment with the FDA.
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.
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.
Good Manufacturing Practices (GMPs):
- Sunscreen products must be manufactured in compliance with Good Manufacturing Practices (GMPs) to ensure product quality and safety.
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.
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 labeler code request to FDA for the establishment.

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 31^st ,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