Category: fda registration drug

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

DUNS NUMBER

A DUN’S number is a unique nine-digit identifier assigned by Dun & Bradstreet (D&B), a business credit bureau. The DUNS Number is location specific. So, each physical location of an entity such as branches, divisions, and headquarters may be assigned a DUN’S number separately.

To market food, drugs and medical devices products in the United States, companies must have DUNS number.

Food: All domestic and foreign food facilities what wants to sell their food products in the US will be required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing food facility registration with FDA. DUNS number is the only acceptable UFI recognized by FDA.

For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.

For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

Drugs: US FDA will directly pull the company information only from FDA’s DUNS portal. So, companies who want to register with FDA must obtain DUNS first and then proceed with registration.

Medical Devices: Even though for now, DUNS number is not mandatory to register, to submit Unique Device Identification (UDI), DUNS is a mandatory requirement.

DUNS number for FDA purposes is free of cost. Facilities registering with FDA must obtain a DUN’S number first. DUNS requests may take up to 30 days.

Liberty Management Group, as leading FDA consultant provide assistance with DUNS number lookup and FDA registration and renewals.

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

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 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 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

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:

  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

OTC MONOGRAPH

An Over-the-Counter (OTC) monograph is a set of regulations established by the U.S. Food and Drug Administration (FDA) for non-prescription drugs. These monographs provide a comprehensive framework for the ingredients, labeling, and therapeutic uses of a specific category of OTC drugs. The monograph system streamlines the process for manufacturers to develop and market safe and effective OTC products without requiring approvals.

The FDA categorizes OTC drugs into various therapeutic classes (e.g., antacids, cough and cold products, pain relief, sunscreens) based on their intended use and active ingredients.

For each therapeutic class, the FDA develops a monograph that outlines the active ingredients, their permitted concentrations, labeling requirements, dosing instructions, and any other relevant specifications. The monograph serves as a standard for products within that category.

The monograph also specifies which active ingredients are generally recognized as safe and effective (GRASE) for treating specific conditions.

The monograph sets labeling requirements, with drug facts which includes use, warnings, and other information that must be included on the product’s packaging. It may also outline testing requirements to ensure product quality and consistency.

Manufacturers looking to create an OTC product within a specific therapeutic class must formulate their product according to the monograph’s specifications. If the product adheres to the monograph’s requirements, it can be marketed without requiring individual FDA approval.

The FDA periodically reviews and updates OTC monographs to reflect new scientific information, safety concerns, and changes in industry standards. Manufacturers are required to adjust their products to comply with updated monograph requirements.

In some cases where a manufacturer wishes to market an OTC product with an ingredient or use that is not covered by an existing monograph, they can pursue an OTC New Drug Application (NDA) or a New Dietary Ingredient (NDI) Notification, depending on the nature of the product.

It’s important for manufacturers to carefully follow the monograph guidelines when developing and marketing OTC drugs to ensure compliance with FDA regulations.

OTC drug manufacturers are required to comply with FDA drug regulations which includes establishment registration, drug listing, label compliance and cGMP regulations.

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.us