Category Archives: Uncategorized

  • dsfsdfsfsf

Cosmetic Labeling FDA requirements

Cosmetic Labeling FDA requirements may vary based on the intended use of the product.  A cosmetic with drug claims may be considered as a drug. 

How does FDA define Cosmetic?

A product used on the human body to clean, beautify, and improve the appearance without affecting the human body’s structure or functions is considered a Cosmetic.

Examples of cosmetic products –  skin creams, lotions, perfumes, lipsticks, fingernail polishes,

How can cosmetics also be a drug? 

Products that are cosmetics but are also intended to treat or prevent disease or affect the structure or functions of the human body are also considered drugs. They must comply with the law’s drug and cosmetic provisions.

For example, shampoo for cleansing purposes is cosmetic. However,  if the same product is labeled as an anti-dandruff product, it becomes both an over-the-counter drug and cosmetic. 

There is a significant difference between Cosmetic Labeling FDA requirements for cosmetics and FDA labeling requirements for  OTC drugs.  Human OTC drug labels must contain the drug facts information. Also, the regulatory requirements for drugs are more extensive than the requirements applicable to cosmetics. The FD&C Act requires that drug manufacturers register every year with the FDA and update their lists of all manufactured drugs twice annually. Additionally, drugs must be manufactured in accordance with current good manufacturing practice regulations as codified at 21 CFR 210 and 211.  

Overview of  Cosmetic Labeling FDA requirements


Cosmetic Labeling FDA requirements

  • The product label should display the principal display and information panel. 
  • Panel size must be large enough to provide sufficient space for the label information.
  • Style & Size of letters must be of a minimum required size that are easily readable.
  • Background contrast must be such that the label statements are conspicuous and easily readable.
  • The label statement must be visible.
  • The principal display panel should display the name of the product (product identity ), Net quantity, or contents and  warning required by the 21 CFR  § 740.10 warning
  • The information panel should display the  Directions for use, ingredient information, other warnings, name and place of the business.

Apart from the above labeling requirements a cosmetic product must comply with FDA recommend ingredient nomenclature and other requirements.  FDAbasics LLC can assist you to comply with  Cosmetic Labeling FDA requirements. Please contact us for more information. 




FDA fee for OTC drugs – OTC monograph Drug User fee

The FDA has published the  OTC  monograph Drug User fee for the fiscal year 2021. FDA refers to the OTC monograph Drug User Fee Program as “OMUFA”. 

FDA fee for OTC drugs explained  

FDA fee for OTC drugs - OTC monograph Drug User fee


Who has to pay the OTC monograph Drug User Fee?  

Facilities that are engaged in the manufacturing or processing of the finished dosage form of an OTC monograph drug are required to pay the fee.  The FDA will assess and collect fees for two types of facilities.


  1. Facility Fees from qualifying owners of OTC monograph drug facilities. (manufacturers and contract manufacturers).
  2. Fees from Submitters of qualifying OTC monograph order request (OMOR).


What is OMOR

The administrative order request to make changes in the OTC monograph is referred to as OMOR. Significant changes such as a request for the addition of a new active ingredient or indication are classified as Tier1 OMOR.  Requests for minor changes such as the addition of an “other information” section in the drug facts, changes to “directions” sections are classified as Tier 2 OMOR.


Definition of Monograph Drug Facility

An OTC monograph drug facility is a foreign or domestic business or other entity that is engaged in manufacturing or processing of the finished dosage form of an OTC monograph drug. This facility is also called a Monograph Drug Facility. (MDF)


Definition of Contract Manufacturing Facility

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


A full facility fee will be assessed to each qualifying person that owns a facility identified as an MDF and a reduced facility fee of two-thirds will be assessed to each qualifying person that owns a facility identified as a CMO facility.


Who is exempted from the facility fee?


OTC monograph drug facilities are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 (should this be 2020?)

The facilities that only manufacture the active pharmaceutical ingredient (API) of an OTC monograph drug do not meet the definition of the OTC monograph drug facility.

A facility is not considered an OTC monograph drug facility if it performs the following functions:

  1. Production of clinical research supplies
  2. Testing
  3. Placement of outer packaging on packages or packages containing multiple products


How are the facilities identified?


The Drug establishment registration database will be utilized for identifying the qualifying facilities.

The FDA utilizes the Agency’s Electronic Drug Registration and Listing System (eDRLS) to estimate the number of qualifying facilities.

A facility fee will not be assessed if the identified OTC monograph drug facility:

  1. Has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year.
  2. Has updated its eDRLS registration to reflect that change (see section 744M(a)(1)(B)(i) of the FD&C Act).

The Agency will assess and collect fees from submitters of OMORs, except for OMORs that request certain safety-related changes. There are two levels of OMOR fees, based on whether the OMOR at issue is a Tier 1 or Tier 2.

OTC monograph Drug User fee structure for FY 2021


Tier 1 OMOR fees


Tier 2 OMOR fees


MDF facility fees


CMO facility fees



When is the Over the Counter (OTC) monograph Drug User fee due? 

OTC monograph drug facility fees for FY 2021 will be due on February 12, 2021, 45 days after publication of this Federal Register Notice.


How is the fee paid?

The OTC drug fee should be paid by creating a user fee cover sheet. FDAbasics can assist you to create the cover sheet and pay the FDA fee, please contact us for more information.



FDA Registration Renewal timelines – when to renew your FDA registration.


Generally, FDA registration renewal timelines are from October 1 to December 31 every year. However, the annual registration requirement may vary based on the product category.

Summary of FDA registration renewal requirements.



Food facility registration renewal timelines


  • Food facilities registration is required every even year between the 1st of October and December 31. For example, food facilities must renew their registration in the years 2020, 2022, 2024, and so on. Failure to timely renew your registration may result in the cancelation of the food facility registration. If food facility registration is not renewed by 11:59 PM on December 31, the registration is considered expired and will be removed from your account.


  • The FDA has abbreviated the biennial registration renewal process for a facility that has not had any changes to its registration information since the previous registration, registration renewal, or update for the facility.


  • However, for the year 2020 food facility registration renewal, a unique facility identifier (UFI) is required.


  • The Data Universal Numbering System D-U-N-S (DUNS) number is an acceptable UFI for the FDA. DUNS numbers are assigned and managed by Dun & Bradstreet.



  • A DUNS number can be obtained free of charge for D&B.


We offer US agent and food facility registration renewal assistance. If you need more information, please contact us.


Medical Device registration renewal timelines 

Medical device facility registration should be renewed every year between October 1 and December 31. Medical device facilities are also required to pay the FDA registration fee.  


The FDA fee for FY 2021 medical device registration is $ 5546. If you register/renew on or before October 1, your registration will remain valid until the end of the next calendar year.


We offer assistance for medical device registration and listing. Contact us for more information.

Drug establishment registration renewal.


Registrants of Drug Establishments are required to renew their facility registration between October 1and December 31. Also, facilities must update or submit the “no change” notification for active drug listings.


There is no FDA fee for drug establishment registration renewal.



We assist companies in registering and renewing drug establishment registration and updating drug listings.


During the annual registration renewal for food facility and drug establishment, the FDA will send an email to the US Agent to confirm if the appointed is US Agent has agreed to act as US Agent for their facility.


We can offer quick and cost-effective services for FDA registration and US Agent services. If you have any questions, please contact us.


How to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer

Fda regulations for hand sanitizer

In this article,  you will understand how to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer. This article will be helpful for companies manufacturing and importing hand sanitizer into the USA.


Even though hand sanitizer containing OTC ingredients (Alcohol and benzalkonium chloride) does not require prior approval from the FDA, you must comply with certain FDA requirements.

Apart from general requirements, such as registration and listing, the product should comply with the FDA’s quality parameters. The FDA does not require companies to submit any testing reports for hand sanitizes. However, the FDA may test your products to confirm the presence of impurities and residual solvents. If any of the impurities are found above the acceptance level, then FDA shall take enforcement action.

Suppose the outcome of FDA testing confirms impurities such as methanol; FDA shall ask companies to recall the product currently distributed in the market. Companies are also responsible for notifying all their consignees affected by the product recall. Product recall notification can be done through a Press release, letter, telefax, telephone, e-mail, visit, etc.

Currently, the presence of methanol and 1-propanol is the reason for product recall.

The FDA strongly recommends testing the product for methanol content in a GMP compliant laboratory and is inspected by the FDA.

Potential Impurities may prevent the hand sanitizer and their acceptance criteria.

The firms using technical grade ethanol that does not meet USP or FCC should test their product for below-listed impurities.

Impurity Interim Limit published under the temporary policy

Methanol NMT 630 ppm

Benzene NMT 2 ppm

Acetaldehyde NMT 50 ppm

Acetal (1,1-diethoxyethane) NMT 50 ppm

Sum of all other impurities NMT 300 ppm

In case, the sum of impurities exceeds 3000 ppm, the firm should test below listed impurities.

Acetone NMT 4400 ppm

n-propanol (1-propanol) NMT 1000 ppm Ethyl acetate NMT 2200 ppm Sec-butanol (2-butanol) NMT 6200 ppm Iso-butanol (2-Methyl-1-propanol) NMT 21700 ppm n-butanol (1-butanol) NMT 1000 ppm iso-amyl alcohol (3-Methyl-1-butanol) NMT 4100 ppm Amyl alcohol NMT 4100 ppm

Failure to perform testing and maintaining propers records are violations of GMP (Good Manufacturing Practice). The FDA may place a firm under import alert for GMP compliance-related violations, which may adversely affect your company’s business in the long term.

Summary of FDA requirements for hand sanitizers

1Compliance with temporary policy for hand sanitizers in terms of formulation, testing, and alcohol quality
2.  Hand sanitizer marketed under OTC monograph should be 3.manufactured under GMP (Good Manufacturing Practice).
4. Compliance with FDA labeling requirements
5. US Agent appointment for foreign companies
6. Registration and listing requirements

Your US Agent plays a vital role in your business when it comes to regulatory compliance. The US Agent is responsible for communicating with foreign companies if there is any product recall or product-related regulatory issue.


FDAbasics offers US Agent and regulatory compliance services to companies to comply with FDA requirements. If you have any questions or need further assistance. Please write to us at [email protected]

FDA establishment registration fee FY 2021

FDA registration fee FY 2021

FDA has published the annual establishment registration fee for FY 2021, which will be effective from October 1, 2020. The FDA registration fee for each medical device establishment is $5,546.

All medical device establishments intended to register/renew their facility are required to pay the establishment registration fee. Waivers or reductions for small establishments, businesses, or groups do not apply to the annual establishment registration fee.

Other medical device regulatory application fees for FY 2021.

Application Type Standard Fee Small Business Fee
510(k) $11,594 $2,899
513(g) $4,603 $2,302
PMA, PDP, PMR, BLA $340,995 $85,249
De Novo Classification Request $102,299 $25,575
Panel-track Supplement $255,747 $63,937
180-Day Supplement $51,149 $12,787
Real-Time Supplement $23,870 $5,968
BLA Efficacy Supplement $340,995 $85,249
30-Day Notice $5,456 $2,728
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$11,935 $2,984

Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020

Understanding Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry


To prepare hand sanitizer as per the FDA’s temporary policy, you should consider compliance with the below requirements.


Because of the public health emergency posed by COVID-19, FDA does not intend to take action against firms6 that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs7 for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present.


  1. Choice of Active ingredients


You have to choose active ingredients from the below two options.


(1) Alcohol (ethanol) that is not less than 94.9% ethanol by volume; OR

(2) United States Pharmacopeia (USP grade) Isopropyl Alcohol

Further, special caution should be taken to ensure any other chemicals on site are not introduced into the ethanol either intentionally or via cross-contamination.


The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.


FDA has published a temporary policy for alcohol producers for use in the hand sanitizer.

  1. Choice of Inactive ingredients  

Glycerin (glycerol) USP or Food Grade

Hydrogen peroxide

Sterile water (e.g., by boiling, distillation, or other processes that results in water that meets the specifications for Purified Water USP)


The hand sanitizer is manufactured according to the following formula consistent with the World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (formulated to 80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (formulated to 75%, v/v) in an aqueous solution. 18 ,19
  2. Glycerin (glycerol) (1.45% v/v).20 c.
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.


The firm does not add other active or inactive ingredients, such as ingredients to improve the smell or taste, due to the risk of accidental ingestion in children. Different or additional ingredients may impact the quality and potency of the product.


Other requirements.

  • Comply with registration /listing requirements- after submission of drug listing your product will appear on the FDA website. Upon completion of registration and listing, firms receive an automatic confirmation from the FDA. They do not need to wait for further communication from the FDA before they begin to manufacture and distribute these products. FDAbasics can assist firms in complying with registration and listing in the shortest period. Please write to us at [email protected] for detailed information.


  • The firm does not add other active or inactive ingredients, such as ingredients to improve the smell or taste.


  • Pay attention on accuracy of the active ingredient  (ethanol or isopropyl alcohol), maintain the records of active ingredient added in each batch.


  • An accurate testing method such Gas Chromatography should be adopted for alcohol content in each batch.


  • The hand sanitizer product is produced as an aqueous solution and not as a gel, foam, or aerosol spray.


  • Comply with labeling requirements ( see the image below)

Disclaimer – FDAbasics LLC publishes the above article based on our current thinking on the FDA ‘s “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry”. The information contained in this site is provided for informational purposes only and should not be construed as legal advice on any subject matter. You should not act or refrain from acting based on any content included in this site without seeking legal or other professional advice. FDAbasics LLC is a private consulting firm and NOT associated with US Food and Drug Administration. 



FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products

Summary of  FDA guidance for alcohol based hand sanitizers (temporary policy)


FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products . Here is the summary of FDA’s temporary policy for hand sanitizers.

Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020,

provided the following circumstances are present:

1. The hand sanitizer is compounded using only the following United States Pharmacopoeia USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

a. Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution

b. Glycerol (1.45% v/v).7

c. Hydrogen peroxide (0.125% v/v).

d. Sterile distilled water or boiled cold water.

The compounder does not add other active or inactive ingredients. Different or additional ingredients may reduce the safety and effectiveness of the product.

2. The compounder pays particular attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used.

3. The hand sanitizer is prepared under conditions routinely used by your facility to compound similar non sterile drugs.

4. The hand sanitizer is labeled consistent with the below mentioned  labeling format.

hand sanitizer labeling  requirements

Here is the link for guidance document published by FDA.

If you have any questions, contact us. 

How to get DUNS number for free

The  DUNS number is a nine-digit unique number assigned by the D&B  (the DUN and Bradstreet), a private company. In this blog, we have explained “How to get DUNS number for free.


Why  DUNS number?

DUNS number for drug establishment registration -Having a  DUNS number is a mandatory requirement for drug establishment registration.


DUNS number for food facilities and food importer – In the preamble to the final rule, FDA stated that it anticipated issuing guidance specifying those UFI(s) that we recognize as acceptable and that the FDA expects to recognize DUNS numbers as acceptable UFI.  During the 2020 food facility registration renewal, a DUNS number is required to complete the biennial registration.


How much it costs for the  DUNS number?

When you search over the internet,  you may find several companies offering assistance for the DUNS number and asking for the money. However, the DUNS number can be obtained free of charge.  It will cost $ 0 to get the DUNS number.


How to get DUNS number for free

  1. Apply for the DUNS on the website. You can find step by step user guide at the below link.
  2. You can also apply for the DUNS on the federal DUNS website at the below link.
  3. If you need a DUNS number within 24 hours, contact your local D&B office.                                                             

Even when you contact your local D&B office, they may say that the DUNS number is chargeable; however, you have to explain to them that the  DUNS number is required for FDA compliance purposes.

In the United States, DUNS number   by contacting D&B by phone at 866-705-5711, via email at [email protected], by visiting D&B’s Website

How much time it will take to get DUNS number

It usually requires 30 days to provide a  DUNS  number upon receiving a completed request. For businesses willing to pay a fee of about $250, Dun & Bradstreet can assign the DUNS number within five days.

How to search the existing DUNS number and update D&B records

You can search your DUNS number on the website and update the company information in D&B records.

FDAbasics can help you to get your DUNS number free of charge. Contact us for more information.

If you are looking for the  FDA registration renewal, then click here. 


FDA requirements for hand sanitizers (FDA regulations for hand sanitizers)

Amid the novel coronavirus outbreak COVID-19, we are getting many questions about FDA requirements for hand sanitizers and other questions related to  FDA regulations for hand sanitizers. 

FDA Regulations for Hand  Sanitizers


On 24th April 2019 FDA published final rule stating that the three active ingredients namely benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are the only active ingredients determined to be eligible for evaluation under the OTC Drug Review for use in OTC consumer hand sanitizers.

At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to determine whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time if these studies are not completed. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.

Summary of FDA requirements for Hand Sanitizers

To market over-the-counter drug (OTC monograph) products such as hand sanitizers, you should comply with the requirements listed below.


  1. Make sure the active ingredients and indication are complying with the OTC monograph.
  2. Drug establishment registration.
  3. Obtaining the labeler code 
  4. NDC Drug listing
  5. Comply with FDA labeling requirements for over the counter drugs.
  6. The product should be manufactured according to GMP (Good Manufacturing Practice)


It will take about 10 business days to obtain the labeler code from the FDA. After receipt of the labeler code, drug listing can be completed within two business days.


You may not need FDA inspection before selling over the counter monograph products, however, the FDA may inspect manufacturing facilities anytime to verify the compliance to Good Manufacturing Practice.

It remains manufacturer /labeler responsibility scientific rationale data safety and effectiveness of the product. 

If you have any questions related to GMP compliance, please contact us.


FDAbasics offers services to comply with FDA requirements for hand sanitizers, please contact us for more information.


Active ingredients published in the final rule  

(a) Alcohol (ethyl alcohol) 60 to 95 percent by volume in an aqueous solution denatured according to the Treasury Department’s Bureau of Alcohol, Tobacco, and Firearms regulations at 27 CFR 212.

(b) Isopropyl alcohol 70 to 91.3 percent by volume in an aqueous solution.

If you are planning to market hand sanitizers, antibacterial or antibacterial hand wash products, FDAbasics can help you to comply with FDA requirements.  Please contact us for more information.

FDA has published a temporary policy for alcohol-based sanitizer, click here for more details.


This article reflects the current understanding of FDAbasics LLC,  does not constitute legal bindings.  

How To Register With The FDA

The US FDA requires facilities that are engaged in manufacturing, processing, packaging, or storing food pharmaceuticals and medical devices sold in the United States to register with the FDA. Therefore, pharmaceutical and device manufacturers must list their facilities and list the products. Companies must annually renew the registration and listings.  FDA US agent is required for foreign facility registration who can also assist for registration and listing. 

The number of laws and oversight can be very overwhelming if you are new to the US market. It’s much better to adopt from the very start instead of trying to fix mistakes after they’ve happened.

FDA Registration and listing  of Medical Devices:

You must register your organization with the FDA if you are a manufacturer, exporter, specification developer, or initial importer of medical devices. Distributors are exempted from the 

  • To register and list your information, log on to FURLS (FDA Unified Registration and Listing System). A user ID and password for accessing the FURLS must be available to the holder or operator. You will need to create one if you don’t have a FURLS account.

An experienced   FDA consultant can offer you services for medical device registration and listing, which can save your time and effort. 


FDA Drug  Establishment Registration  and NDC drug listing  

FDA Drug establishment registration is a mandatory requirement for the companies that manufacture, process, pack, or hold the drug. Such facilities are also required to list the products manufactured in their facility. 

Private label distributors are required to list the products which they distribute. 

It is a mandatory requirement to renew drug establishment registration annually and update the drug listings between 1st October to 31st December every year. 

Foreign drug establishments are required to appoint US Agent for FDA registration purposes. US Agent acts as a point of contact between the foreign company and the FDA. US Agent plays an important role in your business.

Food/drinks and dietary supplements registration requirements 

Each food company (domestic or external) manufacturing, storing, packaging, or keeping food for consumption to humans in the United States shall register its company with the FDA. Facilities are also required to renew the food facility every even year, such as 2020, 2022 …

FDA examples from “foods” which may be produced in a registration facility, but are not limited to how to Register Food & Diet supplements

  • Raw food products of the farm,
  • Drinks including alcoholic beverages
  • And water bottles of dairy products
  • And eggs dietary supplements 
  • Animal feeding-stuffs

A separate registration number is provided for each food facility. You might need to register and receive separate registration numbers for food facilities if you own or run many facilities. The second facility may also be required to register if your service is transferred to another installation.

Under the Food Safety and Modernization Act (FSMA), the international establishment will provide the FDA with a designated U.S. agent’s name and contact information. Such agents are the contact link between the food plant and the FDA.

FDA Cosmetic Industry Registration:

Cosmetic Registration, Voluntary Program (VCRP) is voluntary. Companies can market cosmetic products by complying with the below requirements. 

  • Cosmetics should not make disease curing or treatment  claim 
  • The product should comply with FDA labeling requirements for cosmetics  
  • The ingredient does not cause the cosmetic to be adulterated or misbrands
  • The product should be safe to use

FDA US agents will work with you to ensure the safety, proper labeling, and enforcement of your goods and ingredients.

Your FDA US Agent has established FDA secure email address ?

FDA secure email address is mandatory requirement for receiving regulatory communications through CDER.
Starting  from October  , abbreviated new drug application (ANDA) applicants with secure email accounts will begin receiving action letters (approvals, tentative approvals, complete responses) by secure electronic communication only as the U.S. Food and Drug Administration (FDA), including its Office of Generic Drugs (OGD), continues to move away from paper communications.
Make sure your 356h  includes secure email address, so that  you can receive electronic  communication from FDA related to your ANDA.
FDAbasics offers US Agent services for ANDA applicants and facilitate efficient  communication process between ANDA applicant and FDA.

FDA Drug establishment registration renewal 2020 (for calendar year 2020) is nearing, what should you know before renewal.

FDA Drug establishment  registration renewal  2020   calendar year    will begin   from 1st October, 2019.  Drug establishments which are registered in the year  2019 must  renew the registration  between 1st October  to 31st Decemebr 2019 in order to avoid expiration of  drug  establishment registration.

drug establishment registration renewal

For establishments  submitted  their   initial, updated or annual registration  between  1st October to  31st  Decemebr 2019 , it is considered registered until 31st Decemebr  2020.

What information is required for drug establishment registration renewal  ?

Additional information is not required for registration renewal, you must notify if there are any changes to previously submitted registration.   You must verify , the contact person name, email and address to make sure that all the information is up to date.

FDA does not charge fee   for establishment registration or drug establishment registration renewal in the subsequent  years.

If you fail to renew the registration before  deadline published by the FDA, such establishments will be removed from FDA’s drug establishment   registration database. Also,  the drug listings  in which  such  establishments  are   referred   may  get deactivated.

We offer assistance for Drug establishment renewal at lowest fee. It will take two working days to complete the renewal process.  if you have any questions, contact us. 


Have you received the email from FDA with  NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS?  Here is the detailed action plan for you.  


FDA has started sending emails to labelers (manufacturer /brand owner of the product ), notifying the “NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS.”  There are many drug listings that have not been updated in the calendar year, or no change certification is not submitted to certify that current information is updated or drug listings include manufactured who are currently not registered with FDA. The FDA will inactivate all such outdated drug listings.

FDA  has announced its intention to begin inactivating NDC  drug listing records, which are improperly listed in accordance with FDA requirements.  If your drug listing falls in any of the below criteria, then  FDA may consider as improperly listed.


ndc renewal

  1. Drug listings are not certified as being active and up to date.
  2. Drug listings that are associated with the manufacturing which is not registered with the FDA (Drug Firm Establishment Registration)
  3. Drug listing is not updated, or no change certification is no submitted in the calendar year.

As per FDA registration and listing requirements, it remains the registrant’s responsibility to keep the drug listing up-to-date. If any of these drugs are currently not marketed or discontinued, the registrant must notify the  FDA by submitting the drug listing with marketing end dates.

All the outdated drug listings which are not updated in the current year or without no change certification will be inactivated and removed from the database starting September 12, 2019.

We can help you to verify the status of your drug listings and assist in updating to the current year.  Also, we offer services for drug establishment registration.

It will take less than two working days to update the drug listing to the current year.

If you have any questions, please contact us. 



NDC code requirement and application process explained

How can I apply for NDC code ?

NDC stands for National Drug Code, which is also used for billing and insurance purposes. NDC is a  10 digit code . Each drug product should have a unique NDC code.

NDC Code Format

NDC code


The first five digits of NDC code are assigned by the FDA  known as labeler code. Labeler code identifies the product “labeler” (brand owner or the company who takes ownership of the product).  You can find examples of NDC number format on our website. 

In short,  FDA assigns the first five digits of the NDC Code, and the remaining five digits are assigned by the labaler (brand owner)/manufacturer. Following are the step by step instructions for NDC drug listing. 

  1. Obtain the labeler code
  2. Activate the labeler code 
  3. Register the manufacturer of product  (if not registered , previously )
  4. Submit the drug listing 

After successful submission of drug listing you can find your NDC drug listing  on the Dailymed and FDA NDC database. 

If you are foreign manufacturer or labeler, you have to appoint US Agent for FDA communication. We can act as your US Agent and facilitate communication with the FDA. 

How to convert a 10 digit NDC  11 digit?

You may have to provide for 11 digit NDC for billing purposes. You can convert the existing 10 digit NDC number to 11 numbers by adding an additional “0” in  in the labeler code, Product code or Pack Code. 

10 Digit NDC

11 digit NDC by

Adding  “0” to Labeler code

11 digit NDC by

Adding  “0” to Product  Code

11 digit NDC by

Adding  “0” to  Pack Code





After the initial NDC drug listing, you have to submit the annual no change certification if there is no update made in the calendar year. 

Please note, drug listing one of the requirements for commercially marketed drug products in the United States. You have to also comply with other requirements, such as labeling and GMP.

If you have any questions, do not hesitate to contact us. 


FY 2020 GDUFA Fee Structure

FDA has now published FY 2020 GDUFA Fee.  Below is the summary of  FY 2020 GDUFA Fee structure.


ANDA fee – 

$ 176,237



Program Fee for ANDA applicants  

  Large Size $ 1,590,792 $ 1,862,167 $ 1,661,684
Medium Size $ 636,317 $ 744,867 $ 664,674
Small Size $ 159,079 $ 186,217 $ 166,168





Large Size : 20 or more approved ANDAs;
Medium Size :  between 6 and 19 approved ANDAs;
Small Size  : 5 or fewer approved ANDA

Facility Fee 

Domestic API $ 45,367 $ 44,226 $ 44,400
Foreign API $ 60,367 $ 59,226 $ 59,400
Domestic FDF $ 211,087 $ 211,305 $ 195,662
Foreign FDF $ 226,087 $ 226,305 $ 210,662
Domestic CMO $ 70,362 $ 70,435 $ 65,221
Foreign CMO $ 85,362 $ 85,435 $ 80,221

FY 2020 Medical Device Registration Fee

FDA has published  Medical Device Registration Fee for  FY 2020 .FDA  Medical  device  registration fee

Medical Device establishment registration fee  for FY 2020 is    $5,236 , no waiver or fee reduction for small companies. Medical device registration fee FY 2020  will be effective from 1st October , 2019. 

In order to renew  registration   for FY2020 , medical device establishment  renewal fee $  5236 is applicable.  Facilities which  are registered in FY 2019  must renew the medical device registration and listing before 31st December  2019.  The renewal period for FY 2020 begins on 1st October 2019. 

In order pay medical device registration fee, applicant  must generate the user fee cover sheet.  Here are the step by step instructions for FDA fee payment. 

  1. Create user fee account 
  2. Prepare the use cover sheet for FY 2020 registration 
  3. After submitting  the cover sheet, you can make online  payment 

 Other medical device submission fee for FY 2020

  • 510(k)‡ – Standard Fee 11,594. Small Business Fee 2,899.
  • 513(g) – Standard Fee 4,603. Small Business Fee 2,302.
  • PMA, PDP, PMR, BLA – Standard Fee 340,995. Small Business Fee 85,249.
  • De Novo Classification Request – Standard Fee 102,299. Small Business Fee 25,575.
  • Panel-track Supplement – Standard Fee 255,747. Small Business Fee 63,937.
  • 180-Day Supplement – Standard Fee 51,149. Small Business Fee 12,787.
  • Real-Time Supplement – Standard Fee 23,870. Small Business Fee 5,968.
  • BLA Efficacy Supplement – Standard Fee 340,995. Small Business Fee 85,249.
  • 30-Day Notice – Standard Fee 5,456. Small Business Fee 2,728.
  • Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) – Standard Fee 11,935. Small Business Fee 2,984.
† For small businesses with an approved SBD.
‡ Note: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted by an FDA-accredited Third-Party Reviewer to the FDA.
The FY2020 user fees apply to medical device submissions received by the FDA on or after October 1, 2019. 

A Guide to ANDA Submissions Issued By The FDA

ANDA stands for Abbreviated New Drug Application. The ANDA submission is known to contains Chemistry, Manufacturing and Control information along with bio-equivalence data . The main purpose of the ANDA submission to the FDA is to review as well as ensure potential approval of generic drug the FDA. Once the drug or product receives approval, the applicant is given the freedom to manufacture as well as market the generic drug. The marketing of the specific drug product is aimed at providing a safe, cost-effective, and an effective alternative to the brand-name drug that has been referenced by the company.

Continue reading A Guide to ANDA Submissions Issued By The FDA

US FDA Registration services in India.

We have started our office in India to provide assistance to our Indian customers who are looking for FDA registration. Now you can contact with our  representative in your country for US FDA registration in India.

Our  technical expert team in India can help you to understand FDA requirements for Food, Medical Device , Drugs and Cosmetics and  offer complete assistance for US FDA registration in India.

You can also chat online with our experts or contact us to schedule call with our representatives in India.



Requirements for selling food products in the USA

Food Facility Registration

If you are a foreign company or importing food products manufactured in foreign country, then such foreign facilities are required to appoint U.S Agent and register the facility. Pragmatic Compliance LLC shall act as U.S Agent for food facility registration purpose and register the facility. Our fee for food facility registration including one-year U.S Agent services is $ 299

You can complete our online food facility registration form at the below link and make the payment. It will take less than two working days to obtain food facility registration number. We accept payment through Credit Card, PayPal or Wire transfer.

For Companies Located Outside the USA.

If you are domestic food manufacturing, processing, packing or warehouse facility, you are required to register with FDA. Our fee for domestic food facility registration is $ 199. Please contact us for offline form.

If you are U.S importer or Trader then you are not required to register with FDA, however your manufacturer is required to register with FDA.

Please note, FDA does not issue the food facility certificate and certificate is not required. You will get the food facility registration number from FDA through email. Our company can issue the food facility registration certificate.

Labeling Compliance

Before shipping products to the USA, you should make sure your product labelling is as per FDA requirements. We can offer labelling review services and our fee for per product labelling review is $ 299. In order to review the label, you should provide us label design in PDF or image format. If you fail to proper labelling FDA may detain your products at the port of entry. Generally, it takes 4 working days to complete the labelling review.

We offer discount on multiple labeling review.

Prior Import notice
Before shipping goods, you must notify FDA about arrival of your shipments well in advance by submitting prior import notice.

If you wish to file prior import notice yourself, we can send you the step by step instruction which you can follow and submit the prior import notice. If you want us to submit prior import notice, then our fee for per shipment prior notice filing is $ 20. Your shipping companies /agents may offer prior import notice filing services free of charge, please check them.

FSVP Agent or Importer

Foreign manufacturer is required to identify the importer for FSMA compliance purpose. If you are importer or already have importer in the United States, such importer is responsible for supplier verification responsibilities.

Pragmatic compliance can act as FSVP importer for foreign companies, fee for FSVP Agent services depends on the Product and projected annual sales in terms of USD.

Foreign manufacturer has to go through our supplier evaluation process and we may require several product quality and safety related documents in order to act as FSVP Agent. Please contact us for more information.

Good Manufacturing Practice and HACCP

In order to food and dietary supplements in the United States companies should follow GMP and maintain proper documentation. After the facility is registered you can start shipping the products however FDA may visit your facility at time.

Note: – If you are low acid or canned food manufacturer please contact us for more information.

FDA Registration

Who is required to  comply with  FDA registration  requirements?

Companies involved in  the manufacturing, processing  or packing of  Drug, Medical Device or  Food  are required to register with FDA .  However,  FDA registration requirements  vary based  on the operations performed by the establishment.

1. Drug Companies (OTC, Prescription, Bulk Drugs,  Pharmaceutical Testing  facilities)

Drug establishment registration requirement is applicable to facilities  engaged in the manufacturing , repacking, relabeling, or salvaging of a drug product for commercial distribution .  FDA does not charge any fee for drug establishment registration.

Foreign facilities are required to appoint U.S Agent for drug establishment registration purpose.  FDAbasics   LLC  offers U.S Agent service and establishment registration, you can find more information in our services section. Our fee for establishment registration including one year U.S Agent services is $  500.

Companies are required to complete  initial registration with   5 days of introducing product into commercial distribution. Drug establishment  must be renewed   between October 1 and December 31 of each year.

2.  Medical device establishment registration device listing

FDA has published the chart which will help you to understand  registration requirements.

Further, medical device facilities are also required to pay FDA annual fee.  You can check FDA fees for the current fiscal year at the below link.

Foreign companies are required to appoint U.S Agent for medical device registration and listing  purpose. Our annual fee for U.S Agent services is $ 299 (valid for 12 months from the date of  the fee payment).  We can also assist you for establishment registration and device listing. Our fee for registration and listing assistance is $ 199 (which includes fees for listing of 10 devices).

You can complete our online medical device registration form and make the payment. It will take two working days to complete the medical device facility registration and device listing  after receipt of PCN number from FDA.

Please contact us for more information.

3. Food Facility Registration (Conventional  Foods and Dietary Supplements)

Food  facilities (establishments),  where food is manufactured, packed , processed or stored are required to register  the food facility . Establishment engaged in the distribution , trading or retail business are not required to register with FDA.

You can find retail establishment exemption  flow chart at the below link.

Foreign  food facilities  are required to appoint U.S Agent for  food facility registration purpose.  We can act as your U.S Agent and register the food facility. Our fee for U.S Agent services including food facility registration is $ 299.  You can complete our online food facility registration form.  It will take two working days to get the food facility registration number.

If you have any other questions, please contact us. 


Food Facility Registration Renewal

Biennial Food Facility Registration Renewal Requirements

All  the registered  food facilities are required to renew their registration every even year between October to December, for example if you completed  food facility registration in the month of July 2017, your registration renewal  will be due in the month of December  2018 ,  which you can renew between  October to December 2018  . Your next renewal  will be  due in the month of December 2020.

Pragmatic Compliance offers free  services for food facility registration and renewal  for our clients with active U.S Agent contract with our company. You can  find  more information about our U.S Agent services at  U.S Agent information page.

Pragmatic Compliance  offers U.S Agent services at lowest fees.  You can  sign U.S Agent contract with our company online.

If your initial food facility  registration is  not submitted by  our company then you may have to provide your Food Facility Registration number and PIN number to  renew your food facility registration. If you do not have the access to you facility registration  PIN number ,  our company shall assist you to obtain the PIN number  from FDA.

We can renew your food facility registration renewal within 24 hours  from the time of your request.

Our fee for  domestic food facility registration renewal is $ 159.

If you have any questions or need more information about food facility registration renewal services , please contact us. 

We offer guaranteed lowest  prices and quality services 

US Agent for Medical Device Companies

US Agent for Medical Device companies.

All the foreign medical device companies  who are required to comply with FDA registration requirements should appoint U.S Agent for communication with FDA.  US Agent acts acts as medium of communication between FDA and foreign company.

Pragmatic offer services to act US Agent for Medical Device companies.

Responsibilities of US Agent for Medical Device companies.

The responsibilities of the U.S. agent are limited and include:

  • assisting FDA  to communicate with the foreign establishment,
  • responding to questions related to  foreign establishment’s devices that are imported or offered for import into the United States,
  • assisting FDA for  foreign establishment inspection scheduling
  • incase, FDA is unable to contact the foreign manufacturer , FDA may contact U.S Agent for regulatory communication purpose.
  • Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

Pragmatic Compaliance offer U.S Agent services to foreign companies at competitive  fees. Our fee for U.S Agent services is $ 299 for 12 months.

We do not hike prices during annual renewal or charge any other hidden fees. All prices are upfront.  We confirm FDA  US Agent notifications immediately.

Along with U.S Agent services , we also offer medical device registration and listing services.

Complete our online U.S Agent form to sign U.S Agent contract.


NDC renewal

No Change Certification for drug listing (NDC Drug Listing Renewal )  is a mandatory requirement in order to keep your current drug listing active if you have not updated your existing drug listing in the current calendar year.


ndc renewal

Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is a change since the previous listing and they must submit this information to the FDA via electronic format, These changes include any drug recently introduced in the U.S. commercial distribution which was not previously listed, any drug which commercial distribution has been ceased, any drug reintroduced in commercial distribution and any material changes in any drug listing information previously submitted.

After initial electronic listing, registrants may satisfy the listing certification requirement with respect to unchanged listing information by submitting annual blanket no changes certification of the product listing.

At the time of the annual registration update under Sec.  207.29(b), a registrant may submit a blanket “no changes” certification covering all of its listed drug products for which no changes to reported listing information were made since the last annual registration update or listing submission. This blanket certification applies only to drug listing information that has been submitted electronically.

Any NDC which has not been newly submitted or updated during the calendar year, or certified during the October to December registration renewal period will be considered expired on January 1st of the following year. All expired listings will be removed from publication in the NDC Directory and if you fail to comply with these requirements your products will be considered as adulterated and misbranding.

FDAbasics, offer No Change Certification for product listing. We offer these services for  $ 99 for no change certification. 

Contact us to complete no change certification in 48 hours. 




self identification for FY 2019

FDA’s self identification period for fiscal year 2019  starts from 1st May 2019 and all the facilities involved in generic drug submission are  required to submit, update or re-confirm the self identification on or before 1st June 2019. CDER has started to send  email with below content to all the facilities  who have self identified  in the previous  year.

“Submit, Update, or Reconfirm Self-Identification Information to the Food and Drug Administration (FDA) for Fiscal Year (FY) 2019.


The FY 2019 generic drug facility self-identification open reporting period will begin on May 1, 2019, and run until June 1, 2019.”

We at  FDAbasics offer complete assistance for GDUFA self identification submission to FDA. It is important to understand the classification of your facility whether its CMO or non CMO based which GDUFA fees are applicable.

If you need any assistance on GDUFA self-identification or if you have any questions please contact us.

what you should know about GDUFA II

In the month of August  FY 2018 fees for generic drug application will be published,  which will be based on GDUFA II. We have summarized highlights  of GDUFA II fee structure and how it will benefit small business.

 GDUFA II Highlights  

No fees for  ANDA supplement fees

No facility fees for manufacturing  facilities with unapproved ANDA

If you are just contract manufacturer and do not have affiliation with any ANDA holding  organization then you will pay only one tenth of  proposed  facility fees.


Now ANDA sponsor companies  will pay fixed annual ANDA Sponsor Program fee which depends on the number of ANDAs owned by companies. ANDA fees are divided in three tiers. small, medium and big.

  • Large (companies with 20 or more approved ANDAs);
  • Medium (companies with between 6 and 19 approved ANDAs); and,
  • Small  (companies with 5 or fewer approved ANDAs).

Facilities  which manufacture   both API and FDF will only pay FDF facility fee, as per GDUFA I both API and FDF fees were applicable to such facilities.

GDUFA II has brought relief to small companies who have no approved ANDA , they need not pay the facility fee until ANDA is approved. Once ANDA is approved facility  is applicable from next fiscal year irrespective whether product is in commercial distribution or not.

GDUFA II has also brought  big relief  to contract manufacturing organizations (CMO)   who just manufacturer the product for another ANDA sponsor and do not hold ownership of other  ANDAs or affiliated with companies who own ANDAs  .

If you have any question on GDUFA II fee program please contact us.

U.S Agent Terms and Condition

Pragmatic is private consulting firm and offers U.S Agent services to many companies. Pragmatic is not affiliated with FDA. By accepting this agreement, Pragmatic and Company agree to following terms. Company means the receiving party of services

Pragmatic is acting as U.S Agent for Company to facilitate the communication between  FDA (US Food and Drug Administration) and is only responsible for transmitting the information received from FDA to Company, unless specific service agreement exists..

U.S Agent agreement between Company and Pragmatic will remain effective for 12 months from the date of payment. Unless extended, this is the period specified.

U.S Agent fees do not include any other consulting or any regulatory work unless jointly agreed to by both parties.

Company warrants that information provided in this form is Truthful and Accurate. It remains Companies responsibility to update any change in the provided information.

Company acknowledges that Pragmatic is acting as U.S. Agent between the Company and the Food and Drug Administration and has no involvement or specific knowledge of the Company’s products.

Company will not hold Pragmatic liable for any negligence and/or damages whatsoever including but not limited to any liability arising with respect to the performance of the Company’s products.

Neither party to this contract shall be held responsible for breach of contract caused by an act of God, insurrection, civil war, military or local emergency, or by any act or failure to act by the U.S. Food and Drug Administration.

In case of any breach of terms Pragmatic has right to terminate the services with seven days advance notice. In case of non-payment for renewal of services   Pragmatic may revoke all the provided services  such U.S Agent appointment , registration, listing or any other such services and Pragmatic will not be responsible for any loss faced by Company as result of such action.

Pragmatic shall inform Company seven working days before taking any such actions.

Pragmatic offers the most competitive pricing without compromising quality and any such statements regarding our pricing are not legally binding. However, we welcome our customer’s feedback on pricing and shall try to meet their expectations.

Customers confidentiality is top most priority for Pragmatic and Pragmatic will not intentionally disclose any confidential information to third parties unless mutually agreed to by Pragmatic and Company or required by the law.


FDA Establishment Registration Fees

Our  FDA establishment registration fees is $ 299 there is no hidden . Our services include complete assistance for the following.

  1. Assistance for obtaining DUNS number
  2. Creating establishment registration
  3. Submission of establishment registration to FDA through our ESG
  4. Assistance for obtaining FEI number
  5. Complete assistance till establishment  registration appears on FDA website.

We offer guaranteed lowest price  with quality services.  We offer best quality and price challenge on all our services. 

FDA does not charge any fees for drug facility registration and its free . FDA also does not offer the certificate of registration, companies  can verify the successful  registration on FDA website.  Understand more about establishment registration.   In  order complete establishment registration fill our drug establishment registration form  or you can contact us.

How to market food products in US

In order to market food products you have comply following requirements.

1, Foreign companies  required  to appoint US agent

2. Establishment Registration

3. Labelling

4. GMP manufacturing

5. Prior import notice

Pragmatic can offer you all guidance and required services at lowest fees with quick turn around time. Contact us for more information.


FDA’s Mandatory eCTD requirements ? Are you ready ?

FDA eCTD  format – Electronic Common Technical Document

fda ectd format

From the beginning of  May 5, 2019,  FDA requires, ANDA, NDA, and Master Files regulatory submission in eCTD  format.

Since FDA is mandating electronic submission  requirements from May 5, 2019 for all the  future amendments, annual reports , supplements or any such regulatory filings. But, it is  not mandatory to convert all previous submission in electronic format.

FDA  eCTD  format requires  trained professionals and software for  XML conversion. Moreover, eCTD submission is challenging  process considering FDA’s eCTD  validation requirements.

Electronic regulatory  submission involves  systematic  planing , document structuring  and complying to various requirements. eCTD publishing is crucial work since  small mistake may lead to refusal to receive submission.

eCTD Publishing Services

We at Pragmatic  offer complete solution for  eCTD publishing   of ANDA, NDA and all types of drug  master files including submission  through  our ESG account.   Unlike other companies we just do not convert your submission to eCTD , but we will also assist you locate the documents within  proper sections of eCTD.

Our regulatory experts have in depth knowledge and experience  in handling electronic submissions , with our services you need not to worry about document format, XML conversion or even templates for amendment, annual report or any such regulatory submission, We offer electronic submission services for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), Biologics License Applications (BLAs), and master files at competitive fees with highest quality services.

Our  fees for  eCTD publishing  starts from as low as $ 329 which depends on the type of application and regulatory submission. Please contact us for more information.

Why we   ?

With our services you will get one stop solution for all your regulatory requirements such as US agent service, establishment registration, NDC number, GDUFA self identification, gap analysis   or any other regulatory consulting services. Our services include complete support till acceptance of your regulatory application.

FDA Self Identification For The Year 2016 Started.

As required by Generic Drug User fee act FDA self identification period  for fiscal year  2016 starts on May 1s  2015, and companies can self-identify their facilities till  June  1st ,2015.

Companies who are into generic drug Manufacturing, Testing. Packaging or  Conducts Bioequivalence /Bio analytical study are required to self-identify with FDA by providing the information type of operation they perform such as manufacturing, API manufacturing , testing, etc..

Self-identification process helps FDA to calculate the estimated GDUFA fees for upcoming fiscal year.

Not all the facilities who self-identify are not required to pay the GDUFA fees, only facilities who manufacture or intend to manufacture the finished product or API are required to pay the GDUFA fees.

Failure to self-identification is violation of federal law and may results disciplinary action by FDA.

Tobias Systems can assist companies to self-identify your facilities at the lowest fees and also  provide whether self-identification for  your facility is required or not.

If you have any questions  on self-identification please write to us .

FDA Consultants

FDAbasics  has many years of experience as FDA consultant, we provide FDA consulting services for food, drug, medical device, cosmetic and plastic companies. We understand that , aim of all the regulatory compliance is to bring your products to the markets, so aim of our consulting is to bring your products in to market faster without any major regulatory obstacles. We have discussed here about few points which you consider before hiring any FDA consultants.

Why FDA Consultant ?

NDC Number

What is the NDC Number (National Drug Code)?

NDC  number is a 10 digit number, which is grouped in three sets. 

NDC number has three components  

  1. Labeler code 
  2.  Product code
  3. Pack code 

Labeler code identifies the labeler or responsible owner of the drug. Labeler can be any company that performs operations such as manufacturing, packing, or distributor of the products. 

The second set of  NDC numbers is product specific, so the labeler has to assign three or four-digit product code for each drug they manufacture or distribute. The product code should be unique for each product. Drug products with the same active having different strengths or formulation will be considered as different products.  

The last set of NDC numbers corresponds to pack code, which should identify the pack size and pack type.

So, NDC number format is 10 number digit can be a set of   4-4-2, 5-3-2, or 5-4-1.

Examples of NDC number format


NDC number format

If a company manufactures  Drug A having 25 mg and 50 mg strengths in two pack sizes of 50’s and 100’s count, then the NDC number will be as follows.

Consider 12345, as a 5 digit number as labeler code assigned by FDA to the labeler.

NDC for Drug A 25 mg of 50 counts:- 12345-678-10

NDC  for Drug A 25 mg of 100 counts:- 12345-678-20                                                                           

NDC  for Drug A 50 mg of 50 counts:- 12345-876-10

NDC  for Drug A 50 mg of 100 counts:-12345-876-10

NDC for  Drug A 50 mg of 10 counts blister:- 12345-876-30

In the above example;

12345 is FDA assigned labeler code

678 is the product code for Drug A 25 mg

876 is the product code for Drug A 50 mg

Since there is a change in the active ingredient composition product is changed. 

10 is the pack code for 50  tablets in the container

20 is the pack code for 100 tablets in the container

30 is the pack code for 10 counts in blister

Alternatively, you can assign the 4  digit product code and 1 digit pack code.  However, once you follow the NDC numbering format, the same format should be continued for all future products.

FDAbasics provides complete assistance for obtaining the labeler code,  assigning NDC number, and drug listing. If you have any questions about NDC drug listing, please write to us.

It will take about 10  working days to obtain the labeler code from the FDA. After getting the labeler code, we can help companies to assign the NDC number and completed the drug listing process. 


How to get NDC number

NDC code requirement and application process explained

Please contact us for more information.


Drug Establishment Registration Renewal

As per 21 CFR 207, companies who manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S are required to register their facilities and are required to keep the information updated. Companies  who have registered their establishment are also required to renew the drug firm registration  annually . Drug establishment registration renewal period is between October  1st to December 31st period.

Drug establishment registration and renewal is mandatory for US and non US companies, including prescription , OTC and API   manufacturer, testing and packaging facilities.

Failure to  drug establishment registration and  renewal  in accordance with section 510  and 502 of the Act is a prohibited and products manufactured in such facilities will be deemed as misbranded.

Tobias provides assistance for drug establishment registration renewal with  competitive fees. Our fees for establishment registration renewal is $ 250 which includes preparing your establishment registration SPL and submission.

US FDA Regulatory For Approval In Medical Devices

FDA is the established ultimate authority for providing approval for manufacture of import of medical devices in US. The Congress also appoints it to charge certain fees for this work from the license seekers. The fee is not fixed but is determined in the preceding year’s middle months.

The conditions of seeking registration is not that complicated but in present situation must be submitted digitally if prior approval for otherwise is not already given. The registration process is annual and the owner or the manufacturer also needs to furnish some more information like the work carried out in the mentioned establishment, the nature of work of these devices and a complete list of devices manufactured there. This information is particularly vital as knowing a location in national emergency can help the officials to arrange for them at the shortest notice.

So, if you are applying for the first time, remember your establishment details are important; your device and all other medical devices you manufacture are important to mention, it is also important to mention what are the objectives your device is going to serve and if possible do mention the country of manufacture of the device.

Remember there will me lot many categories of devices according to their purpose and use in treatment. So, it is better if you clearly and explicitly detail all the work to perform is better. Some of the devices will have health implications by their nature and caution and care will be necessary to use and transport them. Clearly state the precautions the device needs, it can save lives.

FDA approval is a long process but not that complicated. If you are weighing the possibilities of mistake you can always approach any of the reputed FDA regulatory consultation and assistance companies. Please remember FDA does not approve or appoint any for consultation, their professional experience is the only thing that stands for them. So, choose wisely.

Is Ebola Making FDA Concerned ??

In July ‘14 FDA in their compliance guidance for manufacture of drugs paid added attention to the NTDs. The Neglected Tropical Diseases. Most of these diseases are confined to the developing world and where the surroundings play an important role.

Apart from the medical reasons for these diseases, there are the causes like sanitation, availability of clean drinking water, basic facilities of living like bed nets to protect against insects in sleep, careless behavior of conduct play crucial contributors. The diseases have been there but the response of FDA is quite surprising.

It is quite clearly understood with the facilities and easy initial permissions that FDA is allowing to the manufacturers for setting up facilities to manufacture drugs for such diseases indicates that FDA is taking serious interest in the development of those drugs. Since most of them do not affect the US citizens or US soil it is quite surprising about their interest in developing or taking so much interest to develop the drug.

If we now bring the Ebola angle to this discussion we can comprehend little more about this. Africa, the incubator of this disease is also a hot destination for adventure loving Americans and their inherent immunity in these diseases will be much lower considering their lack of exposure. So, if a single case breaks out it can turn endemic for US. Rather than tackling a serious problem of medical immaturity they are acting smart.

As of today, scientists are already breaking new barriers to find injections of Ebola that are successful on animals. Who knows this was not a direct outcome of the FDA initiatives and the incentives they offered to manufacturers for this drug, though cloaked in a general support and encouragement??

EDQM Updated CEP Revision And Renewal Guideline.

EDQM update their guideline for Revision and Renewal of


The EDQM has revised the “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs”.

Following are the modifications.

Revised the guidelines according to European guideline on variations to marketing authorisation applications.

The structure of the guidance document  has also been modified.

As a consequence, the document  procedure for revision and renewal management and application forms are updated.

The revised documents have an implementation date of 01 September 2013.

Purple Book For Licensed Biological Products

FDA has published purple book containing list of licensed biological products with reference   product, and biosimilarity.   The lists includes the date on which biological product was licensed under PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.


This list will enable to see whether a biological product of users interest is determined by FDA to be bio similar or interchangeable. This list will also provide reference product exclusivity expiry date.

You can find purple book at below link.

FDA’s Policy On Communicating Drug Approval Information

FDA’s has made effective manual procedure and policy for communicating drug approval information. Considering interest of industry and FDA including press an other international counter parts FDA will make drug approval information (Approval Letter) available on CDER’s website.

In the  published  manual of FDA  it is mentioned  that,   approval and tentative approval letters for original and supplemental drug  applications will be made available through  CDER’s Web site, generally within three  business days of the approval, for the following categories:
1) NDAs and BLAs (Original application,  efficacy supplement labeling supplements )
2) ANDAs identified by the Office of Generic Drugs (OGD)

Labeling information of approved ANDA (RLD only), NDA and BLA  will be published to CDER’s website  within three days of   approval of labeling supplement.

You can find manual at below link