Month: February 2024

WHO NEEDS TO REGISTER WITH FDA?

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, biological products, medical devices, food (including animal food), cosmetics, and tobacco products. It also regulates electronic products that emit radiation.

Foods:

The FDA regulates the safety, labeling, and quality of all other food products except for meat, poultry, and egg products, which are regulated by the US Department of Agriculture (USDA).

In general, it includes Fresh and processed foods, Dietary supplements, Bottled water, Food additives, Infant formulas, fruits, and vegetables.

Drugs:

The FDA regulates the safety, effectiveness, and quality of all human and animal drugs, which includes prescription and over-the-counter drugs, homeopathic drugs, active pharmaceutical ingredients and vaccines and other biological products.

Medical Devices:

The FDA regulates the safety, effectiveness, and quality of all medical devices used in humans which includes a wide range of devices, from simple bandages to complex surgical implants.

Cosmetics:

The FDA regulates the safety of all cosmetics, including makeup, skincare products, and hair care products, Hair care products, lotions, and moisturizers.

Products are categorized based on the label claims and regulated according to intended use.

Liberty Management Group Ltd, as a leading FDA consulting firm providing assistance with FDA registration of food, drug, medical devices and cosmetic products.

Liberty Management Group Ltd, as a leading FDA consulting firm will provide assistance with above all regulatory requirements.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://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