HAND SANITIZERS

Hand Sanitizers are regulated as over the counter (OTC) drug products by FDA.

US FDA has specific regulations to ensure their safety, effectiveness, and quality.

Below is an overview of key FDA regulations.

1. Active Ingredients:

FDA approved Hand Sanitizer active ingredients are as follows:

  • Ethanol (ethyl alcohol) – typically in concentrations of 60% to 95%.
  • Isopropyl alcohol – also commonly used at concentrations around 60% to 91%.
  • Non-Alcohol active ingredient Benzalkonium chloride 0.1 to 0.13%., but alcohol-based hand sanitizers are the most common and effective.

2. Labeling Requirements:

Hand sanitizer products must comply with FDA drug labeling requirements which include:

  • The active ingredient and its concentration.
  • Directions for use (e.g., amount to use and when to use).
  • Warnings (e.g., avoid contact with eyes, keep out of reach of children).
  • Inactive ingredients, if applicable.
  • Expiration date for the product if it has one.
  • Drug facts label if it is marketed as an OTC product.

3. Manufacturing Standards:

Hand Sanitizer manufacturers must comply with FDA GMP quality standards in manufacturing the drug.

4. Compliance with the Registration and Drug listing process:

Since Hand Sanitizers are considered as OTC drugs, the manufacturer must comply with drug establishment registration and drug listing process.

5. Banned Ingredients or Contaminants:

There are certain ingredients that the FDA has banned in manufacturing hand sanitizers. The list of ingredients can be found at https://www.fdahelp.us/fda-registration-hand-sanitiszer.html .

6. Enforcement and Recalls:

The FDA will issue recalls for hand sanitizers that do not comply with regulations, especially if they are found to be contaminated or ineffective. They also monitor the market for false or misleading claims (e.g., claiming to kill 100% of germs or other unproven health claims).

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

FIRST AID ANTISEPTICS REGULATION

First aid antiseptics are regulated by the FDA as over the counter (OTC) drugs. The regulation falls under the FDA’s Over-the-Counter Monograph M003, which outlines specific requirements for labeling, active ingredients, testing and formulation.

The most common antiseptics include alcohol (ethanol, isopropyl), hydrogen peroxide, iodine, menthol, and benzalkonium chloride. Each active ingredient has specific concentration limits and efficacy standards. Based on the monograph permitted combinations of active ingredients are allowed with proper labeling requirements.

Products must comply with drug labeling requirements which include usage instructions, indications, warnings, and other required information. All claims must be supported by evidence.

Manufacturers must ensure their products are safe and effective for their intended use, by following good manufacturing practices (GMP).

Products that comply with the FDA monographs can be marketed without pre-approval. Those that do not comply must undergo the New Drug Application (NDA) process.

First aid antiseptic manufactures must comply with establishment registration and drug listing requirements as well.

Liberty Management Group, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

FDA ACNE REGULATIONS

USFDA regulates acne products and treatments under drugs, cosmetics, and medical devices.

Acne Drug Products

  • OTC Monograph Compliance: OTC acne treatments products must comply with the FDA’s ” Topical Acne Drug Products for Over-the-Counter Human Use ” (Monograph ID:  M006). This monograph specifies the active ingredients, dosage forms, labeling, and conditions under which these products can be marketed without a prescription.
  • Active Ingredients: Commonly used active ingredients in OTC acne products include benzoyl peroxide, salicylic acid, and sulfur. Each active ingredient has specified concentration ranges and usage guidelines.
  • Labeling Requirements: The FDA mandates specific labeling for OTC acne products, including indications for use (e.g., “for the “management/treatment of acne”), directions, warnings, and any potential adverse effects.
  • New Ingredients: If an acne product contains an active ingredient which is not FDA’s OTC monograph, then it must go through the New Drug Application (NDA) process to be approved.
  • cGMP compliance: All acne products must be manufactured in compliance with cGMP regulations.

Acne Treatment Medical devices

  • Device Classification: Acne treatment devices (e.g., light therapy devices) are classified into Class I, Class II or PMA devices based on their risk to patients. Most acne devices fall under Class II, which requires 510K clearance by proving that the device is substantially equivalent to a legally marketed device.

Cosmetic Acne Products

  • Definition: If a product is marketed as a cosmetic (e.g., cleansers, toners, or non-active ingredient-based products claiming to “reduce the appearance of acne”), it is not subject to the same requirements as drugs or devices. However, it must still be safe to use and properly labeled.
  • Label Claims: Cosmetic products must not make drug claims on the labels.

Liberty Management Group, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

SUNSCREEN REGISTRATION

Sunscreen products are regulated by the FDA as over the counter (OTC) drugs. So, manufacturers must comply with drug regulations and guidelines to ensure their products are safe and effective for consumers.

Steps involved in Sunscreen registration are

  1. Monograph Compliance:
    • Sunscreens products must comply with the FDA’s OTC sunscreen monograph, which outlines the active ingredients, labeling, and testing requirements.
    • The current FDA-approved active ingredients for sunscreens include substances like zinc oxide, titanium dioxide, avobenzone, and others.
    • Products that adhere to OTC monograph do not require FDA pre-approval but must follow all regulations.
  2. Establishment Registration:
    • Manufacturers, packers, or distributors of sunscreen products must register their establishment with the FDA.
  3. Product Listing:
    • Once establishment is registered, the manufacturer must list the sunscreen products with the FDA with NDC number.
    • Drug listing includes all the active and inactive ingredients, drug facts label along with labels.
  4. Labeling Requirements:
    • Sunscreens must be labeled according to FDA regulations. This includes information on SPF water resistance, and appropriate usage directions.
    • Warnings and directions must be included to ensure proper use of the product and to minimize risks.
  5. Good Manufacturing Practices (GMPs):
    • Sunscreen products must be manufactured in compliance with Good Manufacturing Practices (GMPs) to ensure product quality and safety.
  6. Testing Requirements:
    • Sunscreens must undergo specific testing to substantiate their SPF claims and water resistance. The results of these tests must be documented and available for FDA review in case of inspection.
  7. Adverse Event Reporting:
    • Manufacturers must report any adverse events related to their sunscreen products to the FDA. This helps the FDA monitor the safety of sunscreens on the market.

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

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us

HAND SANITIZER REGULATION

The FDA (Food and Drug Administration) regulates hand sanitizers to ensure they are safe and effective for consumer use even though it is considered as cosmetics in some foreign countries.

The FDA recognizes ethanol or ethyl alcohol (60% to 95 %) and isopropyl alcohol (70% to 91.3 %) as safe and effective to be used as an active ingredient in hand sanitizers. Benzalkonium chloride is another active ingredient considered safe and effective, though less effective than alcohol-based sanitizers against certain germs.

FDA consider hand sanitizers as OTC drugs and must comply with below requirements.

  • Submit drug listing with unique 10-digit NDC number for each hand sanitizer after FDA assign labeler code to the company.
  • Label Compliance – Antiseptic hand sanitizer must have “Drug Facts” labeling and all other required information like usage, directions, and warnings.
  • Comply with GMP Requirements as per 21 CFR 211 – Hand Sanitizer GMP which requires testing to ensure that the products are free from contamination and impurities.

Manufacturers that continue to make hand sanitizer products as of December 31, 2024, will be identified as OTC monograph drug facilities and be subject to an OMUFA facility fee for FY 2025 whereas if a company stopped the manufacturing process of hand sanitizers and deregister and de-lists their products before December 31st ,2024 will not be subject to FY 2025 OMUFA fee.

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

510K EXEMPTION REGULATIONS

The FDA 510(k) exemption regulations refer to certain medical devices that are not required to undergo the 510(k) (premarket notification process).  These exemptions are designed to streamline the regulatory process for devices that are considered to pose minimal risk to patients and users.

Generally, medical device manufacturers must submit a 510(k) premarket notification to the FDA to demonstrate that their device is substantially equivalent to a legally marketed device (predicate device). But certain low-risk devices are exempt from the 510(k) process. These exemptions can apply to both Class I (general controls) and some Class II (special controls) devices.

Class I Devices: Most Class I devices are exempt from 510(k) requirements, subject to certain limitations. These devices are typically considered less critical devices and poses minimal risk.

Class II Devices: Some Class II devices are also exempt, but this is less common. These devices are considered to pose a moderate risk.

Even if a device is 510(k) exempt, it must still comply with other regulatory requirements such as:

Special Controls: For some Class II devices, specific special controls must be met even if the device is exempt from 510(k).

Devices are classified into various panels, each covering a specific medical specialty, to determine if they are exempt. FDA maintains a database where anyone can check if the device is 510K exempt or not.

Liberty Management Group Ltd, provides assistance with medical device establishment registration, device listings, label review and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us

DRUG DE-LISTINGS

The FDA (Food and Drug Administration) in the United States is responsible for regulating pharmaceuticals, including the approval and potential delisting (withdrawal) of drugs from the market. Drugs can be delisted for several reasons, including safety concerns, lack of efficacy, or when manufacturers fail to comply with regulatory requirements.

If a company no longer markets the drugs for several reasons, then they must de-list it with marketing end date which is the expiration date of last lot manufactured.

All drug listings must be renewed between October 1st and December 31st every year.

Starting January 1st every year FDA will inactivate human drug listings that are not certified between the renewal period of October 1 to December 31.

In addition to that starting from July 1st every year, FDA will begin to inactivate human drug listings that remain active and certified after the June listing update, if it contains at least one establishment that is not currently registered.

A private label distributor (PLD) or finished drug manufacturer can certify the drug listing at any time during that window, including prior to the renewal of the registration of an underlying manufacturer.

Prior to the listing renewal, manufacturers must renew their registration between October 1st and December 31st each year.

If the manufacturer fails to renew their registration, the listings will be considered misbranded for being manufactured at an unregistered establishment.

In July, the FDA will inactivate those active listings which are still linked to an unregistered establishment.

FDA will send Prior notification to the labeler code contacts for any listing in jeopardy of being inactivated, to allow for an update.

FDA inactivation is not the same as de-listing of the drug.  As per FDA regulations, companies must de-list the products when they discontinue manufacturing it for commercial distribution.

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

DUNS NUMBER

A DUN’S number is a unique nine-digit identifier assigned by Dun & Bradstreet (D&B), a business credit bureau. The DUNS Number is location specific. So, each physical location of an entity such as branches, divisions, and headquarters may be assigned a DUN’S number separately.

To market food, drugs and medical devices products in the United States, companies must have DUNS number.

Food: All domestic and foreign food facilities what wants to sell their food products in the US will be required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing food facility registration with FDA. DUNS number is the only acceptable UFI recognized by FDA.

For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.

For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

Drugs: US FDA will directly pull the company information only from FDA’s DUNS portal. So, companies who want to register with FDA must obtain DUNS first and then proceed with registration.

Medical Devices: Even though for now, DUNS number is not mandatory to register, to submit Unique Device Identification (UDI), DUNS is a mandatory requirement.

DUNS number for FDA purposes is free of cost. Facilities registering with FDA must obtain a DUN’S number first. DUNS requests may take up to 30 days.

Liberty Management Group, as leading FDA consultant provide assistance with DUNS number lookup and FDA registration and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

SELF-IDENTIFICATION

The FDA Self-Identification applies to facilities and organizations involved in the development and manufacturing of generic drugs.

Facilities that manufacture or intend to manufacture must submit Self-Identification.

  • Active Pharmaceutical Ingredients (API) of human generic drugs.
  • Finished Dosage Forms (FDF) of human generic drugs.
  • Sites and organizations involved in:
  • Bioequivalence (BE)/bioavailability (BA) sites that are registered as a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing)
  • Testing, repackaging, or relabeling of generic drugs (exempt from user fees)

Self-Identification must be submitted via CDER Direct or ESG portal by generating SPL files.

Under GDUFA, if a facility fails to self-identify, all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded.  It is a violation of federal law to ship misbranded products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of misbranded products. Products are considered as misbranded because of failure of the facility to self-identify are subject to being denied entry into the United States.

Self-identification must be submitted between May 1 and June 1 of each year.

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

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

STEPS INVOLVED IN MEDICAL DEVICE REGISTRATION

The FDA medical device registration process involves multiple steps to ensure the device meets safety and regulatory standards.

Registration Requirements:  The FDA classifies devices into various risk categories Class I, II, III based on their complexity and potential risks.  Based on their classification, the registration requirements vary.  For critical devices, first they must get 510K clearance or PMA and then register.

Pay the Registration Fee:  The FDA requires an annual registration fee for device establishments. Companies can make the payment by creating a user fee account with FDA and obtain a Payment Identification Number (PIN) and Payment Confirmation Number (PCN).

Obtain a FURLS Account:  The FDA uses the Facility and Registration Listing System (FURLS) for device establishment registration and product listing. Companies must create a FURLS account to complete the registration process.

Register the Facility:  Register the establishment that manufactures or distributes the medical device with the FDA through FURLS. This involves providing details like owner information, facility location, and the type of activities your establishment performs related to the device.

Device listing:  Once the facility is registered, list the specific medical device in FURLS. Devices can be identified with the product codes which indicate if the device needs premarket notification or 510k number. If product code needs 510K clearance or PMA, then the device must be listed with appropriate 510K or PMA numbers.

All medical device establishments must renew their registration between October 1st and December 31st every year if they want to market the device in the next FY.

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