Sudha S – Page 3

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

CERTIFICATE TO FOREIGN GOVERNMENT (CFG) – NE (Certificates to Foreign Government for Device Not Exported from the United States.)

Certificates to Foreign Government for Device Not Exported from the United States (CFG-NE) is document issued by FDA issued for legally marketed devices in the U.S that are manufactured by the companies located outside of the United States and are in compliance with the regulations of FD&C act.

Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE) is a self-certification process. By completing the required form, a firm confirms that it is registered with FDA and listed their device with FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is not being exported from the U.S.

Requirements to get the Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE)

The manufacturing facility must have a valid medical device establishment registration and must be located outside of the United States.
All devices must be listed with the FDA.
The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.
Each device(s) identified is not the subject of an import alert, recall, seizure, injunction, or the subject of any other FDA enforcement action.
Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified

Certificate to Foreign government can be requested through CECATS system. It is a voluntary electronic system that allows the manufacturers to request export documents online. CECATS can be accessed by logging into the FDA Furls account.

The fees for export certificate from CDRH are $175 for the first certificate and $85 each for additional certificate upon the request from the customer.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.

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

CERTIFICATE OF PHARMACEUTICAL PRODUCT(CPP) – AN OVERVIEW

CPP is the document that confirms a pharmaceutical product has met the quality, safety, and efficacy standards of the US FDA. CPP can be used to market pharmaceutical products in another country. Also, it helps to streamline the process by providing a summary of the technical data already reviewed and approved.

Pharmaceutical manufacturers and private label distributors who want to export their products to other countries are required to have CPP for their drugs.

Regulatory authorities in the importing countries may ask for CPP to ensure that the drug they are importing is following the regulations of the exporting country.

CPP contains the information about the product, such as its name, dosage form, and active ingredients, drug listing number, manufacturer information and the label image.

It contains a statement confirming the product’s marketing authorization status in the issuing country.

Benefits of getting CPP are getting faster registration process in other countries. Reduced costs for manufacturers by avoiding full re-evaluation of the product and improved access to essential medicines for patients in importing countries.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA drug establishment registration, drug listing and certificate to Pharmaceutical Product.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelphttp://www.fdahelp.us.us

COSMETIC OR DRUG

The classification of a product as a cosmetic or a drug by the U.S. FDA depends on its intended use of the product and how it is marketed. The products are regulated differently based on the classification.

Cosmetic:

As per FDA, a cosmetic is defined as a product “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body’s structure or functions.” Examples include skin moisturizers, perfumes, body cleansers, haircare products, moisturizers, and other skincare products.

FDA has introduced a new regulation under Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for registering the manufacturing facility with FDA and doing product listings.

Drug:

A drug is defined as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body.” This includes over the counter (OTC) medications, prescription drugs, and even some products marketed as dietary supplements.

Drugs are subject to more stringent regulatory requirements, including pre-market approval processes. They must demonstrate safety and efficacy before being allowed on the market.

It’s important to note that the intended use of a product, as determined by its marketing claims, is a key factor in determining its regulatory classification. If a product is intended to cleanse, beautify, or enhance appearance without making drug claims, it is likely to be classified as a cosmetic. If the product claims to treat or prevent a specific condition or disease, it may be classified as a drug.

However, some products, known as “cosmeceuticals,” may have characteristics of both cosmetics and drugs. These products claim to have therapeutic benefits but are often marketed as cosmetics. The classification can sometimes be nuanced, and companies must carefully consider their product claims and formulations to ensure compliance with FDA regulations.

If a product is classified as drug, then it must comply with all applicable drug regulations including establishment registration, cGMP and drug listing.

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

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 1^st and December 31^st 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 1^st and December 31^st 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 1^st and December 31^st every year.

Drug listings: All drug establishments must renew or certify their drugs listed in the previous fiscal years, between October 1st and December 31^st 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 1^st and December 31^st 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

HOMEOPATHIC DRUG REGISTRATION

Homeopathic drugs are regulated differently from conventional drugs, and the regulatory framework has been shaped by the Food, Drug, and Cosmetic Act (FD&C Act) and the Homeopathic Pharmacopoeia of the United States (HPUS).

Homeopathic drugs are subject to the provisions of the FD&C Act, which outlines the legal requirements for safety, efficacy, and labeling of drugs. The FDA recognizes the HPUS as the official compendium for homeopathic drugs in the United States. The HPUS provides standards for the preparation, quality, and labeling of homeopathic products.

Homeopathic drugs must comply with certain labeling requirements, including disclosure of ingredients, indications, and proper dilution information. However, the labeling standards for homeopathic drugs may differ from those for conventional drugs.

Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email: 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:

Annual Renewal: Drug listing information must be updated with the FDA annually. The renewal must be completed between October 1^st and December 31st of each year for the following year .
Electronic Submission: Drug listing renewal must be completed electronically through the FDA’s Electronic Submissions Gateway (ESG) or CDER direct.
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.
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.
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