FDA Registration For Drugs

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. Additionally, foreign establishments must identify a U.S. agent and importers at the time of their registration.

These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S.  Registration information must be renewed annually. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, now requires drug firms to submit annual establishment registrations in the period from October 1st to December 31st of each calendar year. In addition, we remind you that at the time of annual registration, firms must list any drugs not previously listed. The FDA no longer accepts drug establishment registration and drug listing information in paper format unless a waiver is granted.

Any additional updates to drug listing information must be submitted in June and December of each year. Drug establishment registration information allows FDA to identify all manufacturing facilities involved in producing drugs that are in commercial distribution in the United States, and drug listing information helps the FDA maintain a catalogue of all drugs in commercial distribution in the United States. Drugs that are manufactured in establishments that are not properly registered and drugs that are not properly listed as required are misbranded and may be subject to regulatory action.

The FDA relies on registration and listing information for administering many 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.

Drug Establishment and Listing

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, re-packers or re-labellers are also required to list all of their commercially marketed drug products. Drug products that are not properly listed as required are misbranded and may be subject to regulatory action.

Primary Solutions can assist you with:

  • Drug Establishment Registration

  • Drug Listing

  • US Agent requirement

Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must register with the FDA and identify a U.S. agent. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent.
Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments’ Report of Private Label distributors). Changes in the Act, resulting from the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.

Abbreviated New Drug Application (ANDA)

An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

Primary Solutions will assist you throughout the ANDA process which includes:

  • Assistance in developing study protocols

  • Preparation of manufacturing facility for FDA plant inspection

  • Assistance in preparing the submission

  • Preparation for participation in FDA review meetings

  • Participation in FDA review meeting if needed

  • Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug.
    Guidance documents represent the Agency’s current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products. They also establish policies intended to achieve consistency in the Agency’s regulatory approach and establish inspection and enforcement procedures. Because guidance are not regulations or laws, they are not enforceable, either through administrative actions or through the courts. An alternative approach may be used if such an approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.

    ANDA review process includes
    • Labelling
    • Pharmacology and Toxicology
    • Chemistry
    • Manufacturing
    • Controls
    • Microbiology
    • Inspection
    • Testing
    • Bioequivalence

OTC Drug Establishment Registration and Listing Requirements

Over-the-counter drugs are defined as drugs that are safe and effective for use by the general public without a prescription. OTC drug products are those drugs that are available to consumers without a prescription. As with prescription drugs, the Centre of Drug Evaluation and Research (CDER) oversees OTC drugs to ensure that they are properly labelled and that their benefits outweigh their risks.

Primary Solutions provides assistance in preparation and submission for

US FDA Drug Establishment Registration

Drug Listing with US FDA

NDC Labeller code request to US FDA

Review and modify labelling in compliance with US FDA requirements

Review product ingredients in compliance with US FDA requirements

More than 100,000 OTC drug products are marketed, encompassing about 800 significant active ingredients. There are more than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight control drug products.

OTC Monograph

As there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labelling of over 80 therapeutic classes of drugs, for example analgesics or antacids, instead of individual drug products. For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations, and labelling.

The OTC monographs represent regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labelling, and other general requirements. Marketing pre-clearance of OTC drug products by the US FDA is not required if the standards of the applicable monograph are met.

OTC Drug Establishment Registration with US FDA

Domestic and foreign establishments that manufacture, repack, or re-label OTC drug products or import or offer for import OTC drug products to the United States require FDA drug establishment registration, and renew the registration annually, FDA drug establishment registration information should be submitted electronically using SPL files with coded data fields.

US FDA OTC Drug Listing Requirements

Registrants are required to submit initial listing information of all OTC drugs in commercial distribution at the time of FDA establishment registration. Owners and operators of all registered establishments are required to update their drug listing information with US FDA every June and December.

US FDA OTC Drug Labelling Requirements

The US FDA regulates all of the OTC Drug labelling such as immediate container, outer package, package insert etc. The required information’s include Drug Facts labelling and Principle Display Panel labelling. The regulations help to standardize the content and format of OTC Drug labelling.

Drug Master File

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. DMF’s are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file.

Primary Solution’s consultants can assist you to fulfil the US FDA DMF requirements, Our DMF Submission services include.
• Identification of test requirements (for type II DMF and III DMF).
• Identification of testing lab (for type II DMF and III DMF).
• Edit and organize DMF information.
• Submitting DMF to FDA.
• US FDA DMF Agent service.
• Communicating with FDA on behalf of our client.
• Assisting clients to issue LOA (letter of authorization) to FDA.
• Assistance with DMF Annual report submission to FDA.
• Assistance in DMF Closure request submission to FDA.
• Assistance in DMF Reactivation request submission to FDA. (for closed DMF)
The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.
Hence a Drug Master File (DMF) becomes necessary when there is confidential information that a manufacturer does not wish to share with the applicant.
A DMF is submitted solely at the discretion of the holder. A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.
The FDA requirements for each type of DMF’s are different; Primary Solution’s experienced consultants can help you to identify the FDA DMF requirements for your product.
There are five types of DMF:

Type I DMF Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer
Type II DMF Drug Substance, Drug Substance Intermediate, and Material Used in their
Preparation, or Drug Product.
Type III DMF Packaging Material.
Type IV DMF Excipient, Colorant, Flavour, Essence, or Material Used in their Preparation.
Type V DMF FDA Accepted Reference Information.

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