Tag: FDA Drug Listing Renewal

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

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

DRUG DE-LISTINGS

The FDA (Food and Drug Administration) in the United States is responsible for regulating pharmaceuticals, including the approval and potential delisting (withdrawal) of drugs from the market. Drugs can be delisted for several reasons, including safety concerns, lack of efficacy, or when manufacturers fail to comply with regulatory requirements.

If a company no longer markets the drugs for several reasons, then they must de-list it with marketing end date which is the expiration date of last lot manufactured.

All drug listings must be renewed between October 1st and December 31st every year.

Starting January 1st every year FDA will inactivate human drug listings that are not certified between the renewal period of October 1 to December 31.

In addition to that starting from July 1st every year, FDA will begin to inactivate human drug listings that remain active and certified after the June listing update, if it contains at least one establishment that is not currently registered.

A private label distributor (PLD) or finished drug manufacturer can certify the drug listing at any time during that window, including prior to the renewal of the registration of an underlying manufacturer.

Prior to the listing renewal, manufacturers must renew their registration between October 1st and December 31st each year.

If the manufacturer fails to renew their registration, the listings will be considered misbranded for being manufactured at an unregistered establishment.

In July, the FDA will inactivate those active listings which are still linked to an unregistered establishment.

FDA will send Prior notification to the labeler code contacts for any listing in jeopardy of being inactivated, to allow for an update.

FDA inactivation is not the same as de-listing of the drug.  As per FDA regulations, companies must de-list the products when they discontinue manufacturing it for commercial distribution.

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

DRUG LISTING

All domestic or foreign establishments that manufactures or commercially distributes human drug and animal products within the U.S., you are subject to drug establishment registration and drug listing requirements. Establishment Registration and drug listings lets FDA to develop and maintain a catalog of all drug products marketed in the U.S. Registration information provides the locations and contact information for drug establishments and determines sites for inspection. Drug product listing information provides an inventory of all drug products in the market with manufacturing information, which includes inactive ingredients incorporated into marketed drug products. The FDA depends on this registration and listing information for controlling key programs, including post-marketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application. The electronic drug establishment registration and drug listing system (eDRLS) also populates electronic listing databases such as DailyMed and the National Drug Code (NDC) Directory, improving the accuracy and inclusiveness of these databases.

Drug establishments (manufacturers/contract manufacturers, re-packagers, re-labelers) – domestic and foreign – must register with the US FDA and list their products.

There is no registration requirement for Private Label distributors, but they must list their products under their own NDC number.

Listing can be done electronically via ESG portal or FDA’s CDER direct.

Listings must be updated every June and December, or sooner if there are any changes. There is also an annual renewal period (October 1 to December 31) for certification which is called No-change certification (Blanket listing submission)

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

FDA REGISTRATION RENEWAL TIMELINE

FDA registration renewal process is applicable to various FDA regulated products, including food facilities, medical devices, drugs, and more. However, specific renewal requirements and processes are needed based on the type of product or establishment.

Below are the timeline for FDA registration renewals.

Food Facilities: Food facilities must renew their FDA registrations every two years. The renewal period usually opens in October of even-numbered years. Registered food facilities need to submit a renewal registration between October 1st and December 31st of each even-numbered year.

Medical Devices: Owners or operators of establishments that manufacture, repackage, relabel, or remanufacture medical devices for commercial distribution must renew their registration annually with the FDA. This registration must be renewed between October 1st and December 31st each year and pay FDA fee.

Drug Establishments: Establishments involved in the manufacture, repackaging, relabeling, or salvaging of drugs must register with the FDA. Drug establishment registrations must be renewed annually between October 1st and December 31st every year.

Drug listings: All drug establishments must renew or certify their drugs listed in the previous fiscal years, between October 1st and December 31st every year. During this renewal period companies must inform FDA about any update or changes in their drug listings. If they no longer market the drugs, it must be de-listed with marketing end date.

Liberty Management Group , as a leading FDA consultant will provide assistance  with food registration biennial registration renewal, drug establishment registration renewal, medical device registration renewal and drug listing renewal.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

BLANKET LISTING SUBMISSION

The FDA (U.S. Food and Drug Administration) requires drug manufacturers to submit a “blanket listing submission” for all drug products they manufacture. This listing includes information about the drug products and the facilities where they are manufactured.

A blanket listing submission is a process by which pharmaceutical companies provide the FDA with a comprehensive list of all drug products they manufacture. This includes prescription and over-the-counter drugs.

FDA uses this information to monitor and regulate drug products in the United States. It helps the FDA track the availability and safety of drug products, as well as identify manufacturing facilities and labeler codes associated with these products.

Drug manufacturers must submit/update listing every year between October 1st and December 31st even if no changes have occurred.

The submission typically includes detailed information about each drug product, such as its proprietary name, active ingredients, dosage form, route of administration, and National Drug Code (NDC) number. It also includes details about the manufacturing facilities and labeling information.

The FDA now requires electronic submission of these listings through the FDA’s Electronic Submissions Gateway (ESG) in Structured Product Labeling (SPL) format.

Failure to submit or update these listings as required can lead to regulatory action, which includes misbranding and warning letters.

Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

office@libertymanagement.us

www.fdahelp.us

DRUG LISTING RENEWALS

Drug listing is an important regulatory requirement that helps the FDA track and monitor all drugs, including over the counter (OTC) drugs, prescription drugs, and other pharmaceutical products marketed in the United States. Drug listing renewals ensure that the FDA has accurate and up-to-date information about each drug product.

Here are the key points regarding FDA drug listing renewal:

  1. Annual Renewal: Drug listing information must be updated with the FDA annually. The renewal must be completed between October 1st and December 31st of each year for the following year .
  2. Electronic Submission: Drug listing renewal must be completed electronically through the FDA’s Electronic Submissions Gateway (ESG) or CDER direct.
  3. Information Updates: During the renewal process, drug manufacturers or sponsors are required to review and update the information related to their drug products, which includes information such as product formulation, labeling, manufacturer information, and establishment registration.
  4. Consequences of Non-Renewal: Failure to renew drug listings can have serious regulatory consequences. Any drug listing that is required to be certified but is not certified may be considered inactive and removed from the NDC Directory and other publications of listing data.
  5. NDC Assignment: The National Drug Code (NDC) is an essential part of drug listing. Manufacturers should ensure that the NDCs for their drug products are accurate and up to date while renewing their listings.

Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listing renewals and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email : Office@libertymanagement.us

www.fdahelp.us