Tag: FDA Drug registration renewal

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

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 1st and December 31st 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

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

REGISTRATION DE-ACTIVATION

The consequences of not renewing US FDA registration can be significant, depending on the type of facility that operates and the products they manufacture.

Food facilities:

Expired registration: If your registration expires, the FDA will consider it a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Seizure of products: The FDA may seize the products if they believe that the products are manufactured in an unregistered facility or pose a public health risk.

Injunctions: The FDA may seek a court order to prevent from continuing to operate your facility until you come into compliance.

Loss of business: Potential customers and suppliers may be hesitant to do business with a facility that is not in good standing with the FDA.

Medical device establishments:

Expired registration: Like food facilities, an expired registration for a medical device establishment is a violation of the FD&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for medical devices manufactured in unregistered establishments.

Import restrictions: The FDA may restrict the import of medical devices manufactured in unregistered establishments.

Drugs

Expired registration: Like other registration, an expired registration for drug establishments is also violation of FDA&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for drugs manufactured in unregistered establishments. They will consider the drug as misbranded and de-activate all the drugs listed FDA.

Import restrictions: The FDA may restrict the import of drugs manufactured in unregistered establishments. Also, they may seize the products if they believe they are manufactured in an unregistered facility or pose a public health risk.

Liberty Management Group, as a renowned FDA consulting firm can help the companies in renewing the food establishment, drug establishment and medical device establishments in a timely manner.

Sudha

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