JUST YOU KNOW
Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA. There are exemptions.
Registration is required within 5 days of introducing product into commercial distribution. Annual renewal of registration must occur between October 1 and December 31 of each year.
As of September 30, 2016,
9,268 domestic and 3,967 foreign drug establishments were registered with FDA.
FDA's Center for Drug Evaluation and Research (CDER) ensures that drugs marketed in the U.S. are safe and effective, by performing drug reviews, post-marketing risk assessment.
* over-the-counter and prescription drugs
including biological therapeutics and generic drugs
* fluoride toothpaste, antiperspirants, dandruff shampoos, sunscreens
that are considered "drugs".
Prescription Drugs: medicines or any drug product that requires a doctor's authorization for purchase.
Generic Drugs: drug products equivalent to brand name products in terms of quality and performance. A generic drug product is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
Over-the-Counter Drugs: OTC drug products are available to consumers without a doctor's prescription.
The FDA wants to speed up generic drug or OTC (Over-the-Counter) approval process by offering 8-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022.
The FDA currently takes 47 months to approve a generic drug on average, despite the addition of about 1,000 new employees and user fees.
Determination of FDA code and regulation
Investigational New Drug (IND) Application
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA): Generics
Therapeutic Biologics Applications (BLA)
Application for Over-the-Counter (OTC) Drugs
OTC (Over-the-Counter) Monograph registration
OTC product listing
U.S. Agent Service
Assigned by the FDA to all manufacturers, repackers/relabelers or private label distributors. Labeler Codes are all numeric.
Some Veterinary Firms receive the pseudo Labeler Code 1900.
Firms required to register with the FDA, but not drug list their products (Analytical Labs) receive the pseudo Labeler Code 1500.
A National Drug Code (NDC) number cannot be issued without a DUNS number.
Administrative Review and Submission Service do not include
an evaluation of your science, data or technology.
(*) Data Universal Numbering System
(DUNS or D-U-N-S) Number by Dun & Bradstreet, Inc
(*) Full company's name (as registered locally)
(*) Street address, city, postal / zip code, state, country
(*) Full name of CEO / Manager
(*) Telephone number of CEO / Manager
(*) Email of CEO / Manager
(*) Product details
SUBMIT COMPANY INFORMATION
REQUEST AN INVOICE
Payment methods accepted
PayPal, Local European Payments
Debit and Credit Cards
Electronic Invoice, Bank Wire
Federal Food, Drug, and Cosmetic Act (FD&C Act)
The FD&C Act defines drugs as
a substance recognized by an official pharmacopoeia or formulary.
a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
a substance (other than food) intended to affect the structure or any function of the body.
a substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
Applications for Over-the-Counter (OTC) Drugs
FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, instead of individual drug products.
For each category, an OTC Drug Monograph is developed and published in the Federal Register.
OTC drug monographs cover acceptable ingredients, doses, formulations, and labeling.
Companies can make and market an OTC product without the need for FDA pre-approval.
These monographs define the safety, effectiveness, and labeling of all OTC active ingredients.
There are over 300,000 marketed OTC drug products in the U.S.
A New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is required when a product does not conform to a final monograph.
A drug company may also petition to change a final monograph to include additional ingredients or to modify the labeling.
Some drugs switched from Rx to OTC still require NDA
Abbreviated New Drug Application (ANDA)
for generics drugs
Generic drug applications are "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. Bioequivalence was established under the Drug Price Competition and Patent Term Restoration Act of 1984.
FDA generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.
Applicant must show that:
manufacturer is capable of making the drug correctly
manufacturer is capable of making the drug consistently
“active ingredient” is the same as that of the brand
right amount of the active ingredient gets to the place in the body where it has effect
"inactive" ingredients of the drug are safe
drug does not break down over time
container in which the drug will be shipped and sold is appropriate
label is the same as the brand-name drug’s label
relevant patents or legal exclusivities are expired.
* Establishment Registration Fee | Annual
* Product Review Fee | Initial
Due between October 1 and December 31, each year.
User Fees funds are made available to support FDA’s budget under the
Prescription Drug User Fee Amendments of 2012 (PDUFA)
Generic Drug User Fee Amendments of 2012 (GDUFA)
Medical Device User Fee Amendments of 2012 (MDUFA)
Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 (ADUFA
Biosimilar User Fee Act of 2012 (BSUFA)
Drug Quality and Security Act (DQSA).
OTC Monographs are not subject to user fee, yet (Over-the-Counter Monograph Drug User Fee Act - OMUFA).
FY18 (Fiscal Year 2018) GDUFA Fees
Generic Drug User Fee Amendments (GDUFA)
Foreign establishments must notify FDA of the name, address, phone, and email address of their United States agent.
Even if an establishment manufactures various medical devices, drugs, biological products, or cosmetics, each establishment can identify only one United States agent.
Foreign firms that manufacture, prepare, propagate, compound, or process a drug imported or offered for import into the U.S. must
• Designate a U.S. Agent
• Provide names of each known importer
• List all drug products imported or offered for import into the U.S.
Responsibilities of the United States Agent
* Assisting FDA in communications with the foreign establishment
* Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
* Assisting FDA in scheduling inspections of the foreign establishment.
Section 510 of the Federal Food, Drug, and Cosmetic Act requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA.
Prescription drug wholesale distributors and third-party logistics providers (3PLs) must report State licensure and contact information for each facility, and any significant disciplinary actions taken by a State or the Federal Government to the FDA under the Drug Supply Chain Security Act of 2013 (DSCSA).
The Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (FDAMA), amended several sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to:
1. ban the reimportation of prescription human drugs manufactured in the U.S., except when reimported by the manufacturer or for emergency medical care with permission of the FDA
2. prohibit, with certain exceptions, the sale, purchase, or trade (including the offer to sell, purchase, or trade) of prescription human drugs purchased by hospitals or other health care entities, and of prescription human drugs donated or sold at reduced cost to charitable institutions
3. ban the sale, purchase, trade, or counterfeiting of drug coupons
4. ban the sale, purchase, or trade (including the offer to sell, purchase, or trade) of prescription drug samples
5. require state licensing of wholesale distributors of prescription human drugs under Federal guidelines that include minimum standards for storage, handling, and recordkeeping.
6. require unauthorized drug distributors to provide a statement of origin (“pedigree”) as part of certain drug sales.
The Drug Establishments Current Registration Site (DECRS) is a publication of currently registered establishments (facilities) which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S.
Under FD&C act section 510 (c) (d) and (i), establishments must be registered within 5 days of beginning operations. See also 21 C.F.R. Part 207.21(a).
In addition, establishments must renew registration annually between October 1st and December 31st of each year. (FD&C Act sections 510(b) & (i)), and 21 C.F.R. Part 207.29 (3)(b)(1).
Registration of a drug establishment or drug wholesaler, or assignment of a registration number, or assignment of a NDC (National Drug Code) number does not in any way denote approval of the company or its products.
Any representation that creates an impression of official approval because of registration or possession of registration number or NDC number is misleading and constitutes misbranding under the federal Food, Drug, and Cosmetic Act.
NDC format identifies the following
– Labeler code: manufacturer or distributor
– Product code: drug formulation
– Package code: trade package size and type.