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    LIMITED OFFER

    ■ Establishment Registration
    ■ Products Listing
    ■ U.S. Agent Service (Foreign Companies)
    $350.00 USD | Initial Registration Fee

    * $300.00 USD | Annual Fee

    Government Fees are extra.


  • OTC Drugs
  • Prescription Drugs
  • Shampoos, Hair Colors, Deodorants, Skin Moisturizers


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.

CDER regulates

* 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.



ESTABLISHMENT REGISTRATION


WHAT'S INCLUDED?


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

■ NDC (National Drug Code)

■ Establishment registration

■ Product listing

■ OTC product listing

■ U.S. Agent Service



Labeler Code

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.


REQUIRED INFORMATION


(*) 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








Legislation

Federal Food, Drug, and Cosmetic Act (FD&C Act)

Section 505.


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

- Ibuprofen

- Advil



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.

CONTACT



Government Fees

Establishment Registration Fee | Annual


Product Review Fee | Initial



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
AGDUFA)
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).



Fiscal Year 2019 - FY19


Generic Drug User Fee Amendments (GDUFA)

ANDA $178,799
DMF $55,013
Facility Domestic API $44,226
Foreign API $59,226
Domestic FDF $211,305
Foreign FDF $226,305

Prescription Drug User Fee Act (PDUFA)

Each person that submits a human drug application is assessed an application fee as follows:

■ A human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval is assessed a full application fee.

■ A human drug application for which clinical data with respect to safety or effectiveness are not required for approval is assessed one- half of a full fee.

Human drug application fees are due when the application is submitted.


User Fee Type

2019

Application Fee - Clinical Data Required  $             2,588,478
Application Fee - No Clinical Data Required  $             1,294,239
Program Fee  $                 309,915  


Payment must be made in U.S. currency

drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money order, credit card, or wire transfer.

The preferred payment method is
■ online using electronic check (Automated Clearing House - ACH also known as eCheck)
■ or credit card (Discover, VISA, MasterCard, American Express).

Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available.

Use the following account information when sending a payment by wire transfer:

U.S. Department of Treasury
TREAS NYC
33 Liberty St
New York, NY 10045

Account Number: 75060099

Routing number: 021030004

SWIFT: FRNYUS33

Beneficiary: FDA, 8455 Colesville Rd, 14th Floor, Silver Spring, MD 20993-0002

FDA's tax identification number is 53-0196965.





U.S. Agent for Foreign Establishments

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.




FDA COMPLIANCE


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).



Misbranding by Reference to Establishment Registration Number

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.



e-CFR (Electronic Code of Federal Regulations)
August 7, 2018

Title 21  Chapter I → Subchapter D


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D—DRUGS FOR HUMAN USE

rule

Part Table of
Contents
Headings  

rule

300
300.50 to 300.100
GENERAL

310
310.3 to 310.548
NEW DRUGS
312
312.1 to 312.320
INVESTIGATIONAL NEW DRUG APPLICATION
314
314.1 to 314.650
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
315
315.1 to 315.6
DIAGNOSTIC RADIOPHARMACEUTICALS
316
316.1 to 316.52
ORPHAN DRUGS
317
317.1 to 317.2
QUALIFYING PATHOGENS

320
320.1 to 320.63
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328
328.1 to 328.50
OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
329
329.100
NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

330
330.1 to 330.15
OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331
331.1 to 331.80
ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332
332.1 to 332.31
ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333
333.101 to 333.350
TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335
335.1 to 335.50
ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336
336.1 to 336.80
ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338
338.1 to 338.50
NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

340
340.1 to 340.50
STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341
341.1 to 341.90
COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343
343.1 to 343.90
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344
344.1 to 344.52
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346
346.1 to 346.52
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347
347.1 to 347.60
SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348
348.1 to 348.50
EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349
349.1 to 349.80
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

350
350.1 to 350.60
ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352
352.1 to 352.77
SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355
355.1 to 355.70
ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357
357.101 to 357.850
MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358
358.101 to 358.760
MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

361
361.1
PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369
369.1 to 369.21
INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE

370-499
 
[RESERVED]


Useful Acronyms / Import or Export Codes

ABI Automated Broker Interface (with CBP)

ACE Automated Commercial Environment

ACC Accession Number

ACS Automated Commercial System (CBP)

AofC Affirmation of Compliance codes (for FDA)

ANC Annual Report Accession Number

ANDA Abbreviated New Drug Application

API Active Pharmaceutical Ingredient

BLA Biologics License Application

CBER Center for Biologics Evaluation and Research

CBP Customs & Border Protection

CDER Center for Drug Evaluation and Research

CFR Code of Federal Regulations

CM Contract Manufacturer

CMC Chemical Manufacturing Control

CPT Component of Device

DEV Foreign Manufacturer Registration Number

DII Initial Importer Registration Number

DIOP Division of Import Operations and Policy (FDA)

DLS Drug Listing number

FDA Food and Drug Administration

FD&C Act Federal Food, Drug, & Cosmetic Act (FDA)

FEI Facility Establishment Identifier number (FDA)

FP Finished Product

FTZ Foreign Trade Zone (US CBP Regulated)

HDE Humanitarian Device Exemption

HPUS Homeopathic Pharmacopoeia of the United States

IDE Investigational Device Exemption

IFE Import For Export (FDA)

IND Investigational New Drug

ISO International Standards Organization

ITACS Import Trade Auxiliary Communications System

LST Device Listing Number

MARCS Mission Accomplishment and Regulatory Compliance Services

MID Manufacturer Identification code

NDA New Drug Application

NDC National Drug Code

NF National Formulary

OASIS Operational and Administrative System for Import Support (FDA)

ORA Office of Regulatory Affairs (FDA)

OTC Over The Counter

PDP Product Development Protocol number

PLAIR Pre-Launch Activities Importation Request

PLD Private Label Distributor

PMA Premarket Approval number

PMN Premarket Notification number

PN Prior Notice (FDA)

PREDICT Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting tool

REG Drug Facility Registration Number

SPL Structured Product Labeling

TPM Third Party Manufacturer

USDA United States Department of Agriculture

USHTS United States Harmonized Tariff Schedule

USP United States Pharmacopoeia

XML Extensible Markup Language.



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