fda registration drug – Page 3

CERTIFICATE TO PHARMACEUTICAL PRODUCT (CPP)

A Certificate of Pharmaceutical Product (CPP) is an internationally recognized document that confirms the marketing status and regulatory compliance of a pharmaceutical product. FDA is issuing it to facilitate export of FDA-regulated products from the United States.

The CPP provides information about the product, such as the product name, dosage form, strength, manufacturer, and the regulatory status in the country of origin. It serves as evidence that the product is authorized for sale in the country of origin and meets the regulatory requirements for quality, safety, and efficacy.

Foreign governments are seeking official assurance that products exported from the United States to their countries can be marketed in the United States or meet specific U.S. regulations, such as current good manufacturing practice (CGMP) regulations. A foreign government may also require export certification as part of the process register or import a product into that country.

To obtain a CPP, the pharmaceutical manufacturer must apply to FDA where the product is authorized for sale. The application must include information about the product, its regulatory status, and the intended recipient country. FDA will review the application and issue the CPP if the product is deemed to follow their regulations.

It is important to note that the requirements for obtaining a CPP may vary between countries and regions. Some countries may require additional documentation or information, while others may not recognize the CPP at all.

Requirements to get the Certificate to Pharmaceutical Product (CPP)

The manufacturing facility must have a valid drug establishment registration.
All drugs must be listed with FDA.
The drugs should meet all the drug labelling requirements as per 21 CFR 201.
The drugs should be manufactured in accordance with 21CFR 210 also known as Good Manufacturing practice.

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.fdahelp.us

PRIVATE LABEL DISTRIBUTOR

A firm that does not participate in the manufacture or processing of a drug but markets and distributes under its own trade/brand name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.

The private label distributor takes on the responsibility of marketing, branding, and selling the products, while the manufacturer is responsible for producing and supplying the products.

PLDs do not have a registration or listing obligation for drugs since they do not manufacture or process in their facility.

They may elect to submit listing information for a drug they do not manufacture or process directly to the FDA by themselves or if they do not want to list, the manufacturer must submit the drug listings on behalf of the private label distributor.

If the PLD submit the listings under their NDC number, they assume full responsibility for compliance with all listing requirements.

To be a successful private label distributor, it is important to have strong relationships with manufacturers, a clear understanding of market trends and consumer preferences, and effective branding and marketing strategies.

The steps involved in drug listings can be checked at https://www.fdahelp.us/otc-drug-registration-process-fda.html

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

Email: office@libertymanagement.us

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.

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 February 15 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

Mail: Office@libertymanagment.us

www.fdahelp.us

OVER-THE-COUNTER MONOGRAPH DRUG USER FEE PROGRAM (OMUFA)

As per CARES Act, over-the counter (OTC) drugs otherwise known as OTC monograph drugs, can be marketed without an approved drug application if they meet the other applicable requirements. Under this OTC monograph reform legislation, FDA is entitled to assess and collect user fees dedicated to OTC monograph drug activities.

FDA states that OMUFA fee will fund a portion of their regulatory activities for OTC monograph drugs and its performance goals, which includes reviewing of new submissions within specific time frames and inspections.

On March 16^th, 2022, FDA announced the OMUFA for FY 2022.

As per FD&C Act, a facility fee for FY 2022 will be calculated based on the facility that is identified as an OTC monograph drug facility during the fee-liable period from January 1, 2021, through December 31, 2021.

FDA will calculate and collect facility fees with respect to the two types of OTC monograph drug facilities—MDF and CMO facilities. Facility fees will be calculated to each qualifying person that owns a facility identified as an MDF and a reduced facility fee (two- thirds) will be assessed to each qualifying person that owns a facility identified as a CMO facility. FY 2022 facility fees are due on June 1, 2022.

OTC monograph drug facility (MDF) is a foreign or domestic establishment that is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.

A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliated partner or the establishment sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2022

Type of Registration / Application	MDF Facility	CMO Facility
OTC Monograph Drug Facility Fee	$24,178	$16,119

FDA also stated that manufacturers that entered the over-the-counter industry to Supply Hand Sanitizers during the COVID-19 Public Health Emergency are not subject to the Over-the-Counter Drug Monograph Facility Fee (OMUFA) fee.

Below are the facilities exempted from OMUFA.

API Manufacturers.
Clinical Research Supply manufacturers
Testing establishment.
Facilities placing outer packaging on already packaged products containing various products like creating multiple packaging.
Animal drug manufacturers.
Homeopathic drug manufacturers

Liberty Management Group Ltd, a leading FDA consulting group provides assistance with OMUFA PIN creation, API drug establishment registration, Drug establishment registration and listing renewals and US agent service to foreign countries.Homeopathic drug manufacturers

Sudha S

Regulatory Consultant

Mail: Office@libertymanagment.us

https://www.fdahelp.us/

ANIMAL DRUGS

According to FD&C Act, the term “drug” means articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles other than food intended to affect the structure or any function of the body of man or other animals which also includes articles intended for use a component of a drug.

As per FD&C Act “new animal drug” is a drug intended for use in animals which is not in GRASE (Generally Recognized as Safe and Effective) , in other words, if a drug is in GRASE list, then it is not a new animal drug under FDA&C Act.

Unapproved Animal Drugs are new animal drugs that cannot be marketed legally. FDA does not approve or index them. It is not legal to market unapproved new animal drugs as they didn’t gone through FDA pre-market review and got legal marketing status under FD&C Act. Unapproved animal drugs may not meet FDA’s standard for safety and effectiveness and also may not be properly manufactured or labeled.

There are three ways to get a Legal Marketing status of an animal drug.

Approval
Conditional Approval
Indexing

Approval: An approved animal drug has to go through NADA (New Animal Drug Application) process or for an ANADA (Abbreviated New Animal Drug Application) process for an approved generic animal drug. FDA approval means the drug is safe and effective when the drug is used as per the label and also it makes sure that the drug’s strength, quality are consistent for each production and the labeling is correct not misleading.

Conditional Approval: Conditional approval is only for drugs for major species with minor uses. FDA‘s Conditional approval means the drug is safe to use and has reasonable effectiveness when used as per the label instruction. This approval is valid only for one year. Drug companies can ask FDA to renew the approval for up to four more years. So during that 5 year period, companies can sell the drug legally and can also collect effectiveness data. After collecting the data, the company can submit the application to FDA for full approval.

Indexing: An indexed animal drug is a drug listed on the FDA’s Index of Legally Marketed Unapproved New Animal drugs for minor species which is unapproved by FDA but has legal marketing status. Indexing is allowed for drugs used on minor species such as pet birds, hamsters and ornamental fish which are non-food producing. Indexing is different from regular drug approval process. A panel of qualified experts outside FDA will review the drug’s safety and effectiveness in the specific minor species. If FDA agrees with the panel, it will add the drug to the Index.

All domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA and also list all of their drugs that are commercially. Also all the establishments that are registered with FDA are required to renew their registration between October 1^st and December 31^st every year to keep their registration active.

Liberty Management Group Ltd, a leading FDA consulting firm provides assistance with drug establishment registration, drug listing and US agent service to foreign establishments.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

WHAT DOES FDA REGULATES

The Food and Drug Administration (FDA) is in charge for protecting public health by assuring the safety and efficacy of human and animal drugs and biologics, medical devices, tobacco products, human food and animal food for consumption, cosmetics, and electronic products that emit radiation. It also provides precise science based health information to the public.

FDA regulates the following which is a list of traditionally-recognized products that comes under FDA’s regulatory authority.

Foods, which includes

Dietary Supplements
Bottled water
Vegetable and fruit products
Food additives
Infant formulas
Other food products (some of the food products are regulated by USDA such as meat, poultry and egg products).

Drugs, which includes

Over the counter (OTC) drugs
Prescription drugs( Brand name and generic)

Medical devices, which includes

Simple items from bed board and cane
Dental devices
Surgical devices, implants and prosthetics
Complex medical devices such as intraocular lens and pacemakers.

Vaccines, Blood & Biologics, which includes

Allergenics
Blood and Blood products
Tissue and it products
cellular and gene therapy products

Radiation emitting products, which includes

Laser products
X-ray equipment
Ultrasonic therapy equipment
Mercury Vapor lamps
Sunlamps

Cosmetics, which includes

skin moisturizers and cleansers
Color additives found in makeup and personal care products
Nail polish and perfumes

Animal & Veterinary, which includes

Pet foods
Livestock feeds
Animal drugs and devices

Tobacco Products, which includes

Cigarattes
cigarette tobacco
roll-your-own tobacco
smokeless tobacco

Alcohol products are regulated by The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) which monitors the production, importation, wholesale distribution, labeling and advertising.

Consumer Product Safety Commission(CPSC) ensure the safety of consumer goods such as children toys, power tools, cigarette lighters, household chemical products and products that cause a fire, electrical, chemical or mechanical hazard.

Meats, Poultry and certain egg products are regulated by US Department of Agriculture (USDA).

The Environmental Protection Agency (EPA) regulates many traits of pesticides which determines the amount of pesticide used during cultivation, processing and how much can remain on the food we buy. EPA also regulates drinking water, which develops the national standards of drinking water from municipal tap water to limit the level of impurities.

Liberty Management Group, a leading FDA consulting firm provides assistance with registration of food, drug, medical devices and cosmetic companies and also provides assistance with US agent service to foreign companies.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

www.fdahelp.us

SELF IDENTIFICATION – AN OVERVIEW

The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that the manufacturers of human generic drugs, active pharmaceutical ingredients manufacturers (API) and the organizations which support the manufacture or approval of generic drugs to identify themselves electronically and update the information annually to FDA.

Self-identification is a vital requirement to help global supply chain transparency and provide assistance in building an accurate inventory of facilities and organizations involved in the manufacture of generic drugs and also simplifies inspections and compliance.

Who requires Self-Identification?

Facilities that manufacture human generic drug APIs or Finished dosage form of drugs (FDF) or both.
Packager and labeler of generic drugs.
Facilities identified in generic drug submission where the applicant remove the drug from a primary container and subdivide in to different primary containers.
Labs that are performing Bioequivalence (BE)/bioavailability (BA) tests.
Facilities identified in a generic drug submission where the testing is performed to check the characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a cGMP testing requirement

Who requires to pay the fees?

Facilities manufacturing, or intending to manufacture, API of human generic drugs and/or finished dosage form (FDF) human generic drugs.
Facilities that engage in generic drug packaging and labeling (FDA consider these as manufacturing facilities)

Who does not require to pay the fees?

Firms that engages in testing, repackaging or relabeling are not required to pay the fees.

Penalty for not submitting Self– Identification

Under GDUFA, all FDF or API products manufactured at the facility will be considered as misbranded.
Products manufactured in foreign facilities are considered misbranded and it is a violation of federal law to market misbranded products in interstate commerce or to import the products into the United States.

Drug manufacturers’ needs to submit their Self – Identification information to FDA through Electronic Submission Gateway (ESG) by creating Structured Product Labeling (SPL) files.

For FY 2019, the Self-Identification period starts from May 1^st 2019 to June 1^st 2019.

Liberty Management Group, a leading FDA consulting firm provides assistance with SPL preparation and submission of Self-Identification to FDA.

Sudhs S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

BASICS OF IMPORTATION – DRUGS

FDA regulates a range of products which includes food (human and animal consumption), medical products (drugs, devices and biological products), radiation-emitting electronic products, tobacco products and cosmetics. All imported shipments of FDA regulated products are evaluated by FDA and needs to comply with same regulations as of domestic products. The products that are offered into U.S including personal items must be declared to U.S. Customs and Border Protection (CBP). CBP will refers all FDA –regulated products to FDA for review. Mostly, importers will hire a custom broker to help them in submitting necessary entry documents and applicable payments to CBP on behalf of the importer. FDA regulated products are refused to enter in US commerce, if they appear to be adulterated, misbranded, or restricted for Sale. Refused products needs to be destroyed or exported from U.S within 90 days.

DRUGS IMPORTATION

FDA will verify compliance with the following requirements at the time of importation.

FDA Drug Establishment Registration
Drug Listing
NDA or ANDA approval (If applicable)
Conducts field examination and analyzes samples of drugs products to make sure they comply with standard and label requirements.
FDA will make sure that the manufacturer is in not is the list of foreign manufacturers who are not in compliance with drug GMP or import alert.

FDA will verify the manufacturer’s registration and listing by comparing the submitted information to CDER’s registration and listing databases. If the information does not match, FDA will ask for additional information or may detain the product. If the product requires a NDA, ANDA or IND and if does not have it, then FDA will subject the product to refusal.

Foreign establishments whose drugs are imported into United States are required to register with FDA and submit their drug listing information of their products intended for marketing in U.S. If the manufacturer has not registered, they need to register with FDA within 5 days after submitting their application. Also all foreign manufacturers are required to identify a U.S. Agent. FDA Drug establishment Registration and drug listing must be submitted to FDA electronically via CDER unless waiver is granted.

Drug products imported into the United States are subject to FDA labeling requirements. FDA will review the drug labels at the time of importation to check whether they are in compliance with FDA regulations. Specific drug labeling requirements are determined by the type of drug product. OTC drugs, prescription drugs, and drugs imported for drug effectiveness studies are subject to specific labeling requirements in addition to the general drug label requirements.

Liberty Management Group , a leading FDA consulting group in the United States provides assistance with drug establishment registration, drug listing and label review and US agent service for foreign drug establishment firms.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

www.fdahelp.us

NATIONAL DRUG CODE (NDC) – AN OVERVIEW

According to the Drug listing act of 1972, all registered drug establishments must provide the current list of all drugs manufactured, processed, prepared, propagated, compounded or processed for commercial distribution in their facility to FDA. These drugs products are identified and reported by using a unique three segment number called National Drug Code (NDC), which serves as universal product identifier for human drugs.

NDC number is a unique 10-digit, 3–segment numeric identifier assigned to each drug listed under Section 510 of FD&C act. Each NDC number identifies the labeler, product and the trade package size of the drug.

The first segment of NDC is known as labeler code, which is a unique 5 digit number assigned by FDA to each establishment that manufactures (including contract manufacturers, re-packers or re-labelers) or distributes (under its own name- Private label distributor).
Second segment, which is the product code, identifies the specifications (strength, dosage form and formulation) of a drug for a particular manufacturer. This denotes that different formulations or different strengths of the same formulation should be assigned different product codes.
The third segment, the package code, classifies package sizes and types. The second and third segments of NDC should be assigned by the labeler. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.

NDC Labeler code request to FDA should be submitted in SPL (structured Product Labeling) format via FDA ESG (electronic submission gateway). Labeler is responsible for each NDC directory entry submitted through SPL files. Entry in NDC directory doesn’t indicate that FDA approved or verified the information of the drug. Assignment of NDC number to non-drug products is strictly prohibited. Under FD&C act, registration of a drug establishment or assignment of NDC number does not denote that FDA’s approval of the company or its products.

Even though NDC number is a mandatory requirement, but it is not required to appear on all drug labels and including the label of any prescription drug carton given to a consumer. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

NDC Directory does not include animal drugs, blood products, API (Active Pharmaceutical Ingredients), drugs manufactured exclusively for a PLD, or drugs that are marketed as a part of a kit or combination product or inner cover of a multi-level packaged product not marketed separately.

Liberty Management Group Ltd, provides assistance with drugs establishment registration , NDC labeler code request, Drug Listing and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

ACTIVE PHARMACEUTICAL INGREDIENT (API)

According to FDA, an active pharmaceutical ingredient is defined as “any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.”

API is the part of a drug that creates its effectiveness. In some cases, for example in combination therapies there may be multiple active ingredients to treat different symptoms in various ways.

All drugs are manufactured with two main components one: the API which is the main ingredient and others are called inactive ingredients also known as excipients which helps to deliver the medication into the system. Inactive ingredients are components of a drug product that do not surge or affect the medicinal action of the active ingredients. Inactive ingredients are added during the manufacturing process of the pharmaceutical products. Even though inactive ingredients don’t have any therapeutic effects, they are important and necessary components for any medication which plays an important role in drug composition, absorption, delivery and much more.

Manufacturers are using certain standard to determine the potency of the API in each drug. However it varies from one manufacturer to another. But all the manufacturers are required to register their manufacturing establishment with FDA and prove the effectiveness of their drugs through clinical trials.

Under Section 510 of FD&C Act, all firms that manufacture or processing of human drugs are required to register with FDA. The “manufacture” includes the manufacture, prepare and propagation drugs, drug compounding or processing of a drug. The scope of drug manufacturing include drug analysis, active pharmaceutical ingredient (API), final dosage form (FDF), analytical testing, repackaging or relabeling of any drug.

All API manufacturers are required to register their establishment and list their drugs with FDA. API drug manufacturers needs to submit their registration to FDA through Electronic Submission Gateway (ESG) by creating Structured Product Labeling (SPL) files API manufacturer’s drug establishment registration can be verified at https://www.accessdata.fda.gov/scripts/cder/drls/getdrls.cfm and listing can be verified at https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm

Liberty Management Group Ltd, provides assistance with API drugs establishment registration , NDC labeler code request, Drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us