FDA Drug Reporting

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

DRUG REPORTING FINAL GUIDANCE

FDA has issued a new guidance on drug reporting under which registrants of drug establishments are required to submit reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of FD&C act.

As per the guidance, the registrants are required to submit a list of all drugs they manufacture, prepare, propagate, compound, or process for commercial distribution annually. This list must include the name and National Drug Code (NDC) of each drug, as well as other information such as the dosage form, strength, route of administration, and package size.

In the guidance FDA refers “Registrant” as any person that owns or operates an establishment that manufactures, repacks, relabels, or salvages a drug, and is not otherwise exempt from establishment registration requirements under section 510 of the FD&C Act or 21 CFR part 207. See § 207.1.

FDA requires all registrant of drug establishment which includes prescription drugs, over the counter (OTC) drugs, and biologic products, re-packers and re-labelers, active pharmaceutical ingredient (API), and other types of listed drugs, medical gases, homeopathic products, animal drug products, and distributors to submit drug reporting to the agency.

For private label distributors, the data should be submitted separately by the NDC associated with the registrant’s labeler code and the NDC associated with the private label distributor’s labeler code.

Reports on the amount of each registrant’s listed drugs must be submitted yearly. Such reports should include information regarding the amount of drug released for the respective calendar year (January 1 – December 31) and should be submitted no later than March 31st of the following fiscal year.

Liberty Management Group, as a leading FDA consulting firm, can help you in submitting the drug reports to FDA on time.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

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

DRUG REPORTING

To address drug shortages, the FDA has issued a new guidance on drug reporting under which drug establishments are required to submit reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of FD&C act.

As per the guidance, drug manufacturers are required to submit a list of all drugs they manufacture, prepare, propagate, compound, or process for commercial distribution annually. This list must include the name and National Drug Code (NDC) of each drug, as well as other information such as the dosage form, strength, route of administration, and package size.

The FDA uses this information to maintain a comprehensive database of all marketed drugs in the United States. This database is known as the National Drug Code Directory and is used by healthcare providers, pharmacists, and others to identify and track drugs in the supply chain.

FDA requires all drug manufacturers which includes prescription drugs, over the counter (OTC) drugs, and biologic products , re-packers and re-labelers, active pharmaceutical ingredient (API), and other types of listed drugs, medical gases, homeopathic products, animal drug products, and distributors to submit drug reporting to the agency.

Liberty Management Group, as a leading FDA consulting firm, can help you in submitting the drug reports to FDA on time.

Sudha S

Regulatory Consultant

Mail: Office@libertymanagment.us