Sudha S – FDA News

DRUG DE-LISTINGS

DRUG DE-LISTINGS

All drug manufacturers must de-list the drugs with marketing end date from FDA NDC drug code directory if they no longer market the drug for commercial distribution.

Regulatory Requirements

As per 21 CFR 2027, manufacturers or registrants must de-list the drug when they are not going to market it in the United States.
- Registrants must notify FDA if there are any de-listings every June and December.
- Registrants must submit the de-listings with marketing end date which is date of last lot manufacture.

De-listing vs. Inactivation

The key difference between de-listing and Inactivation is as follows.

De-listing: It is action taken by the company to notify FDA that the drug is no longer be marketed in the United States.
- Inactivation: It is the action taken by FDA when the company fails to renew the establishment registration and drug listing between yearly renewal period October 1^st and December 31^st every year. FDA will remove all the drugs listings from its database and the drugs sold after that will be considered as misbranded.

Databases to track down withdrawn drugs.

Withdrawn or Removed list: Drugs which are unsafe or not effective will be removed and these drugs cannot be used by compounders.
- Orange Book: This is database of approved drugs, drugs whose safety or efficacy approval has been withdrawn are excluded from this list.
- NDC Directory: It is a database to find the status of a drug with its NDC number.

Implications of inactivation

Drugs will be considered as misbranded and cannot be legally marketed.
- Selling misbranded drugs can lead to FDA warning letters, product discontinuation, and penalties.
- For foreign manufacturers, FDA will put them on import alert and detain the drugs at the border.
- Insurance will decline the claims if there is no valid NDC number which can lead to loss of reimbursement.

To rectify this, manufacturers can reactivate the drug listings by resubmitting SPL files with correct establishment registration information.

Liberty Management Group provides assistance with drug establishment registration, drug listing and drug listing renewals, and de-listings.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

WHO NEEDS TO REGISTER, LIST AND PAY FOR MEDICAL DEVICE REGISTRATION

Companies including foreign and domestic establishments that are engaged in manufacturing and marketing medical devices including export only devices are required to register yearly with US FDA. Registered establishments are required to list the devices along the activities made on the devices too.

The following are the businesses that are required to register and list the devices.

Manufacture: Establishments that makes by chemical, physical, biological, or other procedures, any article that meets the definition of “device”.

Contract Manufacture: Establishments that manufacture the device as per other establishment specifications.

Specification Developer: Companies that develop specifications for a device that is distributed under the establishment’s own name but performs no manufacturing.

Contract Sterilizer: Provides a sterilization service for another establishment’s devices.

Repackage- Establishments that package the finished devices into different containers excluding shipping containers.

Relabel- Establishments that change the content of the labeling that they have received from the original manufacturer for distribution under the establishment’s own name.

Foreign Export: Establishments that export the devices from a foreign country including the devices manufactured in the United States.

Re-manufacture: A person or establishment who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.

Export only device: Companies who manufactures the devices that are sold only in foreign countries and manufactured in the United States.

Complaint file establishment: Establishments that manage only complaints.

Initial Importer: Any company who furthers the marketing of a device from a foreign manufacturer to the person who makes final sale of the device to the consumer but does not perform any other action on the device.

Establishments that are registered with US FDA must renew their registration every year between October 1^st and December 31^st every year by paying FDA’s MDUFA fees.

Liberty Management Group, as a leading FDA consultant, helps with MDUFA payment, FURLS account creation, medical device establishment registration, device listings and renewals.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

FDA SMALL BUSINESS DETERMINATION (SBD) – AN OVERVIEW

FDA defines “small business” which includes all its affiliates with gross sales or earnings not exceeding $100 million, $30 million, or $1 million, for the most recent tax year, are eligible for small business fee waivers.

Qualified small businesses, with all affiliates with gross earnings of not more than $100 million are eligible for reduced fees for certain type of CDRH submissions that are required to pay user fee by the businesses.

Below are the application types that are eligible for reduced small business fees.

Premarket Notification (510K)
De Novo request
Premarket Approval Application
Biologics License Application (BLA)
Product development Protocol (PDP)
Premarket Reporting (PMR)
PMA/BLA supplements and PMA annual reports
30-day-Notices
513(g) Requests for Information

Small business is eligible for “First premarket application/report” fee waives if the business and affiliate gross income are no more than $30 million for first their PMA, PDP, PMR, or BLA application.

FDA has introduced a new small business fee waiver program for MDUFA fees.

This fee waiver is not applicable for initial registration.

Companies are eligible for small business fee waivers if they satisfy all the requirements below.

business, including its affiliates, has gross receipts or sales of $1 million or less in the most recent tax year,
Must prove that paying the registration fee would represent a financial hardship (for example, proof your business is in active bankruptcy), and
Proof that they had paid the registration fee in a prior fiscal year.

To apply for SBD, companies must get organization ID and submit form 3602N to FDA.

Liberty Management Group Ltd, as leading FDA consultants will provide assistance in creating user fee account, completing and checking form 3602N and providing assistance with Medical device establishment registration and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

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