DRUG LABEL REQUIREMENTS

As per 21 CFR Part 201 and 202, US FDA mandates that prescription and certain OTC drugs must be labeled in such way to ensure both patients and healthcare workers have access to clear and safe way to use medications. Labeling requirements vary depending upon the type of drugs.

Drug label compliance is important in providing information to healthcare providers and consumers and thus protecting public health and severe adverse medical events for the patients.

Labeling of prescription medication is the most important way to communicate with health care providers, patients, and their caregivers.

Most prescription drugs must include FDA approved prescribing information called package insert which includes.

  • Drug name (proprietary and established/generic name)
  • Indications and usage
  • Dosage and administration
  • Dosage forms and strengths
  • Contraindications
  • Warnings and precautions
  • Adverse reactions
  • Drug interactions
  • Use in specific populations (e.g., pregnancy, lactation, pediatric, geriatric)
  • Overdosage
  • Description
  • Clinical pharmacology
  • Nonclinical toxicology
  • Clinical studies
  • How supplied/storage and handling
  • Patient counseling information

Over the counter (OTC) drug facts label must include the information below.

  • Active ingredient(s)
  • Purpose
  • Uses
  • Warnings
  • Directions
  • Other information (e.g., storage)
  • Inactive ingredients
  • Questions or comments (manufacturer contact information)

Drug labeling must be accurate and should not be misleading. Labels must be clear, readable, and consistent with FDA approved prescribing information.

All drugs marketed in the United States must be listed with unique NDC number, but not required to appear on all drug labels.

Liberty Management Group as a leading FDA consulting firm provides assistance with drug listing and label review services.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

BEMOTRIZINOL REGULATION

US FDA regulates sunscreens as OTC drugs not as cosmetics. The manufacturers of sunscreen products must comply with drug standards such as active ingredient requirements, specific SPF and broad-spectrum testing methods and Drug facts labeling.

Apart from that, sunscreen manufacturers must comply with all drug registration requirements, including cGMP (Current Good Manufacturing Practice), Establishment registration, FDA Labeler code request, Drug listing and drug label compliance and they are entitled to pay OMUFA fee as well.

Active Ingredients

Sunscreens use either mineral or chemical UV filters. The FDA permits a specific set of active ingredients, with a notable update expanding the list:

  • Bemotrizinol: It is first new active ingredient added by FDA to OTC monograph under CARES Act after 2 decades since it is recognized as Generally Recognized as Safe and Effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.
  • Zinc Oxide and Titanium Dioxide: These two mineral filters are the only ones currently classified as Generally Recognized as Safe and Effective (GRASE)
  • Chemical Filters: Twelve other chemical filters are currently undergoing review for GRASE status, requiring additional safety data.
  • Banned Ingredients: PABA and trolamine salicylate are deemed not safe and effective.

Dosage forms

FDA approved dosage forms of sunscreen are oils, lotions, creams, gels, butters, pastes, ointments, sticks are classified as GRASE.

For newly approved OTC monograph active ingredients like Bemotrizinol, FDA limits this to pump sprays or bag-on-valve systems to prevent propellant contact and minimize inhalation risks.

Wipes or Towelettes, body washes or cleansers and shampoos are not considered as GRASE so these forms cannot be sold without approved NDA.

Labeling and Claims Requirements

  • Water Resistance: Manufacturers cannot use terms like “waterproof,” “sweatproof,” or “sunblock”. Instead, labels must explicitly state if the product remains effective for 40 or 80 minutes while swimming or sweating.
  • Broad-Spectrum Protection: Sunscreens with SPF 15 or higher would be required to provide broad-spectrum protection, meaning they must protect against both UVA and UVB radiation.
  • Protection Limits: Sunscreens cannot claim to provide protection for longer than 2 hours without reapplication.
  • The FDA proposed clearer labeling requirements for sunscreen products to help consumers identify key product information such as effectiveness claim, Water resistance statements, statement of identity, indications of use, warnings, and direction of use.

All OTC drug products, including sunscreens, must have an expiration date unless stability testing shows they remain stable for at least three years.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

DRUGS – WHO NEEDS TO REGSITER

As per FD&C act, all domestic and foreign establishments that manufacture, prepare, propagate, compound, or process drug products for commercial distribution in the United States must register regardless the establishment manufacture human drugs, animal drugs, active pharmaceutical manufacturers, or biologics.

Who Must Register

As per FDA establishment registration guidelines, business operations below are required to register with FDA.

  • Drug Manufacturers: Facilities producing active pharmaceutical ingredients (APIs), bulk drugs, or finished dosage forms.
  • Contract Manufacturers: Third-party organizations that manufacture or process products on behalf of another company.
  • Re-packers and Re-labelers: Companies that take bulk drug products, split them into smaller commercial packages, or alter the product labeling.
  • Drug Salvagers: Entities that retrieve, recondition, or analyze drugs affected by disasters (e.g., fires or floods) to determine if they are fit for commercial sale.

Foreign facilities exporting drug products to the U.S. market must register their establishments before shipping their goods. They are legally required to appoint a single U.S. Agent who lives or operates a business physically within the United States. This agent serves as the official point of communication between the FDA and the foreign firm.

The FDA exempts certain entities from registration if they manage drugs in the ordinary course of their local business operations.

  • Pharmacies, hospitals, clinics, and licensed practitioners dispensing or administering drugs directly to patients.
  • Research facilities utilizing drug products solely for teaching, analysis, or scientific research without commercial sale.
  • Private label distributors (PLDs) who market drugs under their own brand name but utilize a registered third-party facility to oversee the actual manufacturing, repacking, or relabeling.
  • Storage and transport facilities that only hold or move drug products without altering the product or its packaging.

All registered establishment must submit the list of drugs manufactured in their facility with a unique National Drug code (NDC).

Initial drug listings must be submitted within 3 days after registration of the establishment via Structured Product Labeling (SPL) format.

Establishment registration must be renewed annually between October 1 and December 31.

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

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

OMUFA FY 2026

The OTC Monograph drug user fee program (OMUFA) is the user fee paid by OTC monograph drug manufacturers and contract manufacturers.

OTC Monograph drug facility is defined as a foreign or domestic establishment that satisfies the requirements below.

  1. Under one management and at one geographic location that manufactures or process finished dosage form of an OTC monograph drug
  2. It also includes the finished dosage form of the drugs manufactured under contract.
  3. It does not include the drug used for clinical research supplies, testing, and creating multiple packing.

OTC Monograph Drug facilities registered with FDA from January 1, 2025, through December 31, 2025, are liable for the FY 2026 FDA fees.

Type of Registration / Application MDF Facility CMO Facility
OTC Monograph Drug Facility (OMUFA) Fee $19,188 $12,792

FDA will send invoices to establishment directly and the fees must be paid within 20 calendar days of the original due date. Failure to do so will result in following.

  1. Establishment name will be published on FDA publicly available arrear list.
  2. OTC monographs drug manufactured in such facility will be considered misbranded.
  3. OTC monographs order request submitted by a person will not be accepted for filings until all fees that are due will be paid fully.
  4. Person who owes the fees to FDA shall be considered ineligible for OTC monograph drug meetings until they pay the fee in full.

As part of the transition in FY 2027, facility fees will be assessed in two installments: 50 percent will be due on October 1, 2026, and the remaining 50 percent will be due on February 1, 2027.

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

Sudha S

Regulatory Consultant

Email: Office@libertymanagement.us

www.fdahelp.us

NDC REFORMATION

US FDA has finalized a rule to follow a uniform 12-digit format for NDC instead of current 10-digit format. This change is happening because FDA is running out of 5-digit labeler codes and will soon need to issue 6-digit codes to accommodate new manufacturers.

As per new standard NDC numbers will be in strict 6-4-2 structure, totaling twelve digits: 

  • Labeler Code: six digits (identifies the manufacturer or distributor).
  • Product Code: four digits (identifies the specific strength, dosage form, and formulation).
  • Package Code: two digits (identifies package size and type). 

Existing 10-digit NDCs will change to this new format by adding leading zeros to the short segments as needed. For example, a 5-3-2 format code like 12345-678-90 will become 012345-0678-90. 

The transition is planned with a long lead time to allow the healthcare industry to update their IT systems, insurances, databases, and labeling processes. 

Below is the timeline for New NDC format implementation

Final Rule Published March 5, 2026
Effective Date March 7, 2033
Transition Period March 7, 2033 – March 6, 2036
Full Enforcement After March 7, 2036

FDA is giving 3-year transition period starting from March 7, 2033, through March 6, 2036, for the manufacturers, distributors, pharmacies, health care providers, and other agencies to update their system to manage 12-digit NDC number.

As per new rule, both linear and nonlinear barcodes may be used to meet recognized standards like GS1. This allows a single 2D data matrix barcode to satisfy both NDC requirements and Drug Supply Chain Security Act (DSCSA) identifier rules.

FDA will automatically update all drug listing SPL files to show 12-digit NDC format on the effective date. Drug manufacturers will not need to resubmit or update their listings for the new NDC format. Drug manufacturers are expected to their drug listings and labeling to reflect new NDC format.

FDA has exempted certain biologics like certain specified human cells, tissues, and cellular and tissue-based products to continue to use an FDA- approved alternative format.

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

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

ANTACIDS FDA REGULATION

Antacids are over the counter (OTC) drugs that helps with indigestion and heartburn by neutralizing stomach acids. Usually, antacids come in chewable tablets or liquid can be purchased from pharmacies without any prescription.

The active ingredients used in antacids vary depending on the type of brand. The most common ingredients are as below.

  • Alginate.
  • Aluminum hydroxide.
  • Calcium carbonate.
  • Magnesium carbonate.
  • Magnesium hydroxide.
  • Magnesium trisilicate.
  • Sodium bicarbonate.

To market Antacids in the US, below are process the company must comply with.

  • Drug establishment registration
  • Product listing
  • Label compliance
  • cGMP regulations

1. Drug Establishment Registration

Every domestic or foreign establishment that manufactures, repacks, or relabels drug products (including antacids) for the U.S. market must register with the FDA. 

  • Timing: New facilities must register within 5 days of beginning operations.
  • Renewal: Registration must be renewed annually between October 1 and December 31.
  • Verification: Registration can be verified at  https://www.accessdata.fda.gov/scripts/cder/drls/

2. Product Listing

  • Registered facilities are required to list all drug products they market. Each product is assigned to a unique National Drug Code (NDC). 
  • Compliance: Most antacids marketed under OTC Monograph M001.11, which sets standard rules for safety.

3. Label compliance

  • Labels must include “Drug facts’ with indications, warnings, direction of use and contact information to report adverse events.

Liberty Management Group , as a leading FDA consultant will provide assistance  with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

DRUG DE-LISTINGS

DRUG DE-LISTINGS

All drug manufacturers must de-list the drugs with marketing end date from FDA NDC drug code directory if they no longer market the drug for commercial distribution.

Regulatory Requirements

  • As per 21 CFR 2027, manufacturers or registrants must de-list the drug when they are not going to market it in the United States.
    • Registrants must notify FDA if there are any de-listings every June and December.
    • Registrants must submit the de-listings with marketing end date which is date of last lot manufacture.

De-listing vs. Inactivation

The key difference between de-listing and Inactivation is as follows.

  • De-listing: It is action taken by the company to notify FDA that the drug is no longer be marketed in the United States.
    • Inactivation: It is the action taken by FDA when the company fails to renew the establishment registration and drug listing between yearly renewal period October 1st and December 31st every year. FDA will remove all the drugs listings from its database and the drugs sold after that will be considered as misbranded.

Databases to track down withdrawn drugs.

  • Withdrawn or Removed list: Drugs which are unsafe or not effective will be removed and these drugs cannot be used by compounders.
    • Orange Book: This is database of approved drugs, drugs whose safety or efficacy approval has been withdrawn are excluded from this list.
    • NDC Directory: It is a database to find the status of a drug with its NDC number.

Implications of inactivation

  • Drugs will be considered as misbranded and cannot be legally marketed.
    • Selling misbranded drugs can lead to FDA warning letters, product discontinuation, and penalties.
    • For foreign manufacturers, FDA will put them on import alert and detain the drugs at the border.
    • Insurance will decline the claims if there is no valid NDC number which can lead to loss of reimbursement.

To rectify this, manufacturers can reactivate the drug listings by resubmitting SPL files with correct establishment registration information.

Liberty Management Group provides assistance with drug establishment registration, drug listing and drug listing renewals, and de-listings.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

WHO NEEDS TO REGISTER, LIST AND PAY FOR MEDICAL DEVICE REGISTRATION

Companies including foreign and domestic establishments that are engaged in manufacturing and marketing medical devices including export only devices are required to register yearly with US FDA. Registered establishments are required to list the devices along the activities made on the devices too.

  The following are the businesses that are required to register and list the devices.

Manufacture: Establishments that makes by chemical, physical, biological, or other procedures, any article that meets the definition of “device”.

Contract Manufacture: Establishments that manufacture the device as per other establishment specifications.

Specification Developer: Companies that develop specifications for a device that is distributed under the establishment’s own name but performs no manufacturing.

Contract Sterilizer: Provides a sterilization service for another establishment’s devices.

Repackage- Establishments that package the finished devices into different containers excluding shipping containers.

Relabel- Establishments that change the content of the labeling that they have received from the original manufacturer for distribution under the establishment’s own name.

Foreign Export: Establishments that export the devices from a foreign country including the devices manufactured in the United States.

Re-manufacture: A person or establishment who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.

Export only device: Companies who manufactures the devices that are sold only in foreign countries and manufactured in the United States.

Complaint file establishment: Establishments that manage only complaints.

Initial Importer: Any company who furthers the marketing of a device from a foreign manufacturer to the person who makes final sale of the device to the consumer but does not perform any other action on the device.

Establishments that are registered with US FDA must renew their registration every year between October 1st and December 31st every year by paying FDA’s MDUFA fees.

Liberty Management Group, as a leading FDA consultant, helps with MDUFA payment, FURLS account creation, medical device establishment registration, device listings and renewals.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

FDA SMALL BUSINESS DETERMINATION (SBD) – AN OVERVIEW

FDA defines “small business” which includes all its affiliates with gross sales or earnings not exceeding $100 million, $30 million, or $1 million, for the most recent tax year, are eligible for small business fee waivers.

Qualified small businesses, with all affiliates with gross earnings of not more than $100 million are eligible for reduced fees for certain type of CDRH submissions that are required to pay user fee by the businesses.

Below are the application types that are eligible for reduced small business fees.

  1. Premarket Notification (510K)
  2. De Novo request
  3. Premarket Approval Application
  4. Biologics License Application (BLA)
  5. Product development Protocol (PDP)
  6. Premarket Reporting (PMR)
  7. PMA/BLA supplements and PMA annual reports
  8. 30-day-Notices
  9. 513(g) Requests for Information

Small business is eligible for “First premarket application/report” fee waives if the business and affiliate gross income are no more than $30 million for first their PMA, PDP, PMR, or BLA application.

FDA has introduced a new small business fee waiver program for MDUFA fees.

This fee waiver is not applicable for initial registration.

Companies are eligible for small business fee waivers if they satisfy all the requirements below.

  • business, including its affiliates, has gross receipts or sales of $1 million or less in the most recent tax year,
  • Must prove that paying the registration fee would represent a financial hardship (for example, proof your business is in active bankruptcy), and
  • Proof that they had paid the registration fee in a prior fiscal year.

To apply for SBD, companies must get organization ID and submit form 3602N to FDA.

Liberty Management Group Ltd, as leading FDA consultants will provide assistance in creating user fee account, completing and checking form 3602N and providing assistance with Medical device establishment registration and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

WART REMOVER REGULATION

Warts are noncancerous growths on the skin or mucous membranes caused by the human papillomavirus (HPV).

Salicylic acid is the only FDA approved active ingredient at concentrations between 5% and 40% subject to the delivery base like plaster/collodion-like or karaya gum, glycol plaster vehicle.

Since wart removers are considered as OTC drugs, the manufacturers must comply with all drug requirements such as establishment registration, drug listings, cGMP requirements and labeling.

In the labeling, they must include “Wart remover” along with the established name of the drug.

The labels must carry the indications of use, direction of use, warnings and contact phone numbers to call.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

http://www.fdahelp.us