DRUG REPORTING

To address drug shortages, the FDA has issued a new guidance on drug reporting under which drug establishments are required to submit reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of FD&C act.

As per the guidance, drug manufacturers are required to submit a list of all drugs they manufacture, prepare, propagate, compound, or process for commercial distribution annually. This list must include the name and National Drug Code (NDC) of each drug, as well as other information such as the dosage form, strength, route of administration, and package size.

The FDA uses this information to maintain a comprehensive database of all marketed drugs in the United States. This database is known as the National Drug Code Directory and is used by healthcare providers, pharmacists, and others to identify and track drugs in the supply chain.

FDA requires all drug manufacturers which includes prescription drugs, over the counter (OTC) drugs, and biologic products , re-packers and re-labelers,  active pharmaceutical ingredient (API), and other types of listed drugs, medical gases, homeopathic products, animal drug products, and distributors to submit drug reporting to the agency.

For private label distributors, the data should be submitted separately by the NDC associated with the registrant’s labeler code and the NDC associated with the private label distributor’s labeler code.

Reports on the amount of each registrant’s listed drugs must be submitted yearly. Such reports should include information regarding the amount of drug released for the respective calendar year (January 1 – December 31) and should be submitted no later than February 15 of the following fiscal year.

Liberty Management Group, as a leading FDA consulting firm, can help you in submitting the drug reports to FDA on time.

Sudha S

Regulatory Consultant

Mail: Office@libertymanagment.us

www.fdahelp.us

OVER-THE-COUNTER MONOGRAPH DRUG USER FEE PROGRAM (OMUFA)

As per CARES Act, over-the counter (OTC) drugs otherwise known as OTC monograph drugs, can be marketed without an approved drug application if they meet the other applicable requirements. Under this OTC monograph reform legislation, FDA is entitled to assess and collect user fees dedicated to OTC monograph drug activities.

FDA states that OMUFA fee will fund a portion of their regulatory activities for OTC monograph drugs and its performance goals, which includes reviewing of new submissions within specific time frames and inspections.

On March 16th, 2022, FDA announced the OMUFA for FY 2022.

As per FD&C Act, a facility fee for FY 2022 will be calculated based on the facility that is identified as an OTC monograph drug facility during the fee-liable period from January 1, 2021, through December 31, 2021.

FDA will calculate and collect facility fees with respect to the two types of OTC monograph drug facilities—MDF and CMO facilities. Facility fees will be calculated to each qualifying person that owns a facility identified as an MDF and a reduced facility fee (two- thirds) will be assessed to each qualifying person that owns a facility identified as a CMO facility. FY 2022 facility fees are due on June 1, 2022.

OTC monograph drug facility (MDF) is a foreign or domestic establishment that is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.

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

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2022

Type of Registration / Application MDF Facility CMO Facility
OTC Monograph Drug Facility Fee $24,178 $16,119

FDA also stated that manufacturers that entered the over-the-counter industry to Supply Hand Sanitizers during the COVID-19 Public Health Emergency are not subject to the Over-the-Counter Drug Monograph Facility Fee (OMUFA) fee.

Below are the facilities exempted from OMUFA.

  1. API Manufacturers.
  2. Clinical Research Supply manufacturers
  3. Testing establishment.
  4. Facilities placing outer packaging on already packaged products containing various products like creating multiple packaging.
  5. Animal drug manufacturers.
  6. Homeopathic drug manufacturers

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.Homeopathic drug manufacturers

Sudha S

Regulatory Consultant

Mail: Office@libertymanagment.us

https://www.fdahelp.us/

MEDICAL DEVICE AND DRUG RENEWAL REQUIREMENTS

Medical Devices

According to FD&C act Title 21 CFR part 807, all domestic and foreign medical device establishments that are involved in the production and distribution of medical devices intended to be used in the United States are required to renew their registration annually between October 1st and December 31st every year.  Federal government has authorized FDA to collect an annual establishment fee for medical device establishments.  List of establishment that need to renew and pay the fees can be found at https://www.fdahelp.us/Pdf/Drug.pdf .  The establishment registration fee is not eligible for a reduced small business fee.

 All foreign manufacturers must identify at least one importer in their registration before they send the shipment to the United States.  In turn, US importers also need to identify the foreign manufacturer at the time of renewal of registration. FDA will verify the manufacturer registration status at the port of entry by comparing the submitted information with CDRH’s establishment registration and listing database. If the information does not match, FDA will ask for more information and also may detain the product at the port if the firm lacks required registration and listing.

Drugs

As per FD&C act Title 21 CFR part 207, all domestic and foreign drug establishments registered with US FDA must renew their registration every year between October 1st and December 31st. The renewal of registration must be submitted to FDA in SPL format via FDA’s Electronic Submission Gateway (ESG) with the same original set id used in original registration.  Drug establishments need to update the registration at the time of renewal if there is any change is company information.

All foreign drug manufacturers must update their registration with US importer information at the time of renewal of registration.  FDA will verify the registration status of manufacturer at the port of entry by comparing the submitted documents with CDER Drug Establishments Current Registration Site. FDA may consider the drug products misbranded and detain it at the port, if the firm did not renew the registration.

Drug Listing Renewal

As a new regulation started in FY 2016, FDA will deactivate drug listing records in its database that are not properly listed in accordance with FDA requirements as these drug listings are not certified as being active and up to date or the manufacturing establishment is not registered with FDA. FDA wants the registrants to notify if the drugs are not in commercial distribution and ask them to put an end marketing date in the listings. Also, FDA requires firms to submit drug listings updates if there are any material changes to information previously submitted which includes change in manufacturing establishment(s). Drugs with inactivated listing records cannot be legally marketed or imported in the US. The Blanket listing no change certification must be submitted to FDA between October 1st and December 31st every year.

Liberty Management Group Ltd, a leading FDA consulting group provides assistance with medical device establishment registration renewal, drug establishment registration renewal, drug listing renewal and US agent service to foreign countries.

Sudha S

Regulatory Consultant

Mail: Office@libertymanagment.us

www.fdahelp.us

ANIMAL DRUGS

According to FD&C Act, the term “drug” means articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles other than food intended to affect the structure or any function of the body of man or other animals which also includes articles intended for use a  component of a drug.

 As per FD&C Act “new animal drug” is a drug intended for use in animals which is not in GRASE (Generally Recognized as Safe and Effective) , in other words, if a drug is in GRASE list, then it is not a new animal drug under FDA&C Act.

Unapproved Animal Drugs are new animal drugs that cannot be marketed legally.  FDA does not approve or index them.  It is not legal to market unapproved new animal drugs as they didn’t gone through FDA pre-market review and got legal marketing status under FD&C Act.  Unapproved animal drugs may not meet FDA’s standard for safety and effectiveness and also may not be properly manufactured or labeled.

There are three ways to get a Legal Marketing status of an animal drug.

  1. Approval
  2. Conditional Approval
  3. Indexing

Approval: An approved animal drug has to go through NADA (New Animal Drug Application) process or for an ANADA (Abbreviated New Animal Drug Application) process for an approved generic animal drug. FDA approval means the drug is safe and effective when the drug is used as per the label and also it makes sure that the drug’s strength, quality are consistent for each production and the labeling is correct not misleading.

Conditional Approval: Conditional approval is only for drugs for major species with minor uses.  FDA‘s Conditional approval means the drug is safe to use and has reasonable effectiveness when used as per the label instruction. This approval is valid only for one year. Drug companies can ask FDA to renew the approval for up to four more years.  So during that 5 year period, companies can sell the drug legally and can also collect effectiveness data.  After collecting the data, the company can submit the application to FDA for full approval.

Indexing: An indexed animal drug is a drug listed on the FDA’s Index of Legally Marketed Unapproved New Animal drugs for minor species which is unapproved by FDA but has legal marketing status.  Indexing is allowed for drugs used on minor species such as pet birds, hamsters and ornamental fish which are non-food producing.  Indexing is different from regular drug approval process.  A panel of qualified experts outside FDA will review the drug’s safety and effectiveness in the specific minor species. If FDA agrees with the panel, it will add the drug to the Index.

All domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA and also list all of their drugs that are commercially. Also all the establishments that are registered with FDA are required to renew their registration between October 1st and December 31st every year to keep their registration active.

Liberty Management Group Ltd, a leading FDA consulting firm provides assistance with drug establishment registration, drug listing and US agent service to foreign establishments.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

MEDICAL DEVICES – WHO NEEDS TO REGISTER?

Establishments that are involved in the manufacturing and distribution of medical devices that are used in commercial distribution in the United States which includes import for export only devices are required to register with FDA annually. 

As per 21 CFR Part 807, most establishments that are registered with FDA are also required to list the devices with FDA.

Below are the list of requirements for registration and listing depending on the type of activity conducted in the establishment.

Manufacturer:  Establishments engaged in manufacture, preparation, propagation, compounding, and assembly or processing of a medical device intended for commercial market in the United States are required to register, list and pay FDA fees. This also includes the manufacturers of accessories that are packed or labeled for commercial distribution for health related issues to an end user, kit assemblers and also manufacturers of custom device and U.S establishment that manufactures for export only.

Contract Manufacturer: Manufactures a finished device as per other establishment’s specification are called as contract manufacturer. Since contract manufacturer meets the definition of finished device manufacturer they are also required to register, list and pay FDA fees.

Specification Developer: Specification developerare the ones who creates the specification for a device which are marketed under the establishment’s name but do not manufacture the device. In addition to that, they also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer. Specification developers are required to register, list with FDA and pay the fees.

Contract Sterilizer: Establishments that provide sterilization service for another establishment’s device are required to register, list with FDA and pay the fees.

Re-processor of Single Use Device: Establishments that remanufacture single use device are required to register, list with FDA.

Re-packager or Re-labeler: Establishments that packages finished devices from bulk or re-package devices manufactured into different containers are required to register and list with FDA.  Also establishments that changes the content of the labeling from the original manufacturer for distribution under establishment’s own name.

Remanufacturer: Any person or a firm who processes, refurbishes, conditions, repackages or does any other operation to a finished device that considerably changes the finished device’s performance are required to register, list with FDA.

Foreign Exporter: Establishments in a foreign country that exports finished device to United States for commercial distribution are also required to register and list their devices with FDA.

Initial Importer: Any establishment with a physical address in the United States which furthers the marketing of a medical device from a foreign manufacturer, who make the final delivery to the end user, but does not repackage or relabel or change the device package are required to register with FDA and also needs to identify the foreign manufacturer.

All companies that register with FDA are required to renew their registration and pay FDA fees for the following Fiscal year between Oct 1st and Dec 31st every year to keep their registration active.

Liberty Management Group Ltd, is a leading FDA consultant provides assistance with FDA registration, medical device listing and registration renewal and U.S agent service for foreign facilities.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

http://www.fdahelp.us

MEDICAL DEVICE REPORTING (MDR)

Every year FDA receives thousands of reports of deaths associated with medical devices, serious injuries and device faults. Medical Device Reporting (MDR) is one of the monitoring tool that FDA uses to check the device performance, to find device –related safety issues and contribute to risk and benefit assessment of medical devices.

Who needs to report?

Manufacturers:  Manufacturers are required to report to FDA when they find any of their devices may have caused or contributed to a death or serious injury and device malfunction.  They must also report if there is any death or serious injury if the malfunction were to recur.

Importers:  Importers are required to report to FDA and the manufacturer as soon as they find out that one of their devices may have caused to contribute to a death or serious injury. However the importer must report only to the manufacturer if their imported devices have malfunctioned and would likely to cause death or serious injury if the malfunction were to recur.

Device User Facilities: A “device user facility” is a hospital, nursing home, ambulatory surgical facility, outpatient diagnostic or treatment facility (not a physician’s office).  User facilities are required to report to both FDA and the manufacturer.  If the manufacturer is unknown, user facilities are required to report only to FDA if there is any medical device related injury or death. User facilities are not required to report any device malfunction but can voluntarily report to FDA by using MedWatch  through Electronic Medical Device Reporting (eMDR)

Voluntary Medical Device Reporting: FDA urges healthcare professionals, patients, caregivers and consumers to submit voluntary reports if there is any significant adverse events or device malfunction through MedWatch program.

Liberty Management Group Ltd, is a leading US FDA consulting group provides assistance with food, drug, medical device and cosmetic registration and US Agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

www.fdahelp.us

COMBINATION PRODUCTS

A combination product is a product consist of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.

As per FDA 21 CFR 3.2, a combination product is defined as

  • A product consist of two or more elements for example, drug/device, biologic/device, drug/biologic or drug/device/biologic that are physically, chemically combined to form a single unit which is often referred as “single-entity” combination product. Some examples of single entity combination products are Syringes, insulin injector pen metered dose inhalers.
  • Two or more products packaged together in a single packet or as a package that has drug/device products, device/biologic products or biologic/drug products are often referred as “co-packaged” combination product. Examples of co-packages combination products are first aid kits containing devices(band aids and gauze) and drugs (antibiotic ointments and pain killers)
  • A drug/device/biological product packaged separately that as per the label it is intended for use only with an approved individually specified drug/device/biological product, where both are required to attain the intended use and upon the approval of proposed product, the labeling of the approved product needs to be changed are referred as “cross-labeled” combination product. Examples of cross-labeled combination product is Photosensitizing drug and activating laser/light source
  • Any investigational drug/device/biological products packaged separately and as per its proposed labeling it can be used only another individually specified investigational drug/device/biological product where both are required to have the same intended use which are referred as another type of “cross-labeled” combination product.

Section 503(g) (1) of FD&C act requires FDA to assign a component of the agency to primary jurisdiction for the regulation of combination product.  The assignment of jurisdiction is based on the “primary mode of action” of the combination product.  For example, if the primary mode of action of a combination product is a biological product, then it is assigned to FDA component which is responsible for the premarket review of that biological product.

Combination products are marketed under an authorization type connected with the constituent part that gives the primary mode of action (PMOA) for the combination product.  For example, it should have NDA or ANDA if it has drug PMOA, a biologic license application (BLA) if it has a biologic PMOA or PMA (Pre-market approval) or 510K clearance if it has a device PMOA.

GMP requirements are applicable to all combination products that has drug/device/biologic constituent part.

Liberty Management Group, a leading FDA consulting firm in the United States will provide assistance with FDA registration of combination products.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

http://www.fdahelp.us

WHAT DOES FDA REGULATES

The Food and Drug Administration (FDA) is in charge for protecting public health by assuring the safety and efficacy of human and animal drugs and biologics, medical devices, tobacco products, human food and animal food for consumption, cosmetics, and electronic products that emit radiation. It also provides precise science based health information to the public.

FDA regulates the following which is a list of traditionally-recognized products that comes under FDA’s regulatory authority.

Foods, which includes

  • Dietary Supplements
  • Bottled water
  • Vegetable and fruit products
  • Food additives
  • Infant formulas
  • Other food products (some of the food products are regulated by USDA such as meat, poultry and egg products).

Drugs, which includes

  • Over the counter (OTC) drugs
  • Prescription drugs( Brand name and generic)

Medical devices, which includes

  • Simple items from bed board and cane
  • Dental devices
  • Surgical devices, implants and prosthetics
  • Complex medical devices such as intraocular lens and pacemakers.

Vaccines, Blood & Biologics, which includes

  • Allergenics
  • Blood and Blood products
  • Tissue and it products
  • cellular and gene therapy products

Radiation emitting products, which includes

  • Laser products
  • X-ray equipment
  • Ultrasonic therapy equipment
  • Mercury Vapor lamps
  • Sunlamps

Cosmetics, which includes

  • skin moisturizers and cleansers
  • Color additives found in makeup and personal care products
  • Nail polish and perfumes

Animal & Veterinary, which includes

  • Pet foods
  • Livestock feeds
  • Animal drugs and devices

Tobacco Products, which includes

  • Cigarattes
  • cigarette tobacco
  • roll-your-own tobacco
  • smokeless tobacco

Alcohol products are regulated by The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) which monitors the production, importation, wholesale distribution, labeling and advertising.

Consumer Product Safety Commission(CPSC) ensure the safety of consumer goods such as children toys, power tools, cigarette lighters, household chemical products and products that cause a  fire, electrical, chemical or mechanical hazard.

Meats, Poultry and certain egg products are regulated by US Department of Agriculture (USDA).

The Environmental Protection Agency (EPA) regulates many traits of pesticides which determines the amount of pesticide used during cultivation, processing and how much can remain on the food we buy. EPA also regulates drinking water, which develops the national standards of drinking water from municipal tap water to limit the level of impurities.

Liberty Management Group, a leading FDA consulting firm provides assistance with registration of food, drug, medical devices and cosmetic companies and also provides assistance with US agent service to foreign companies.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

www.fdahelp.us

SELF IDENTIFICATION – AN OVERVIEW

The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that the manufacturers of human generic drugs, active pharmaceutical ingredients manufacturers (API) and the organizations which support the manufacture or approval of generic drugs to identify themselves electronically  and update the  information annually to FDA.

Self-identification is a vital requirement to help global supply chain transparency and provide assistance in building an accurate inventory of facilities and organizations involved in the manufacture of generic drugs and also simplifies inspections and compliance.

Who requires Self-Identification?

  1. Facilities that manufacture human generic drug APIs or Finished dosage form of drugs (FDF) or both.
  2. Packager and labeler of generic drugs.
  3. Facilities identified in generic drug submission where the applicant remove the drug from a primary container and subdivide in to different primary containers.
  4. Labs that are performing Bioequivalence (BE)/bioavailability (BA) tests.
  5. Facilities identified in a generic drug submission where the testing is performed to check the characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a cGMP testing requirement

Who requires to pay the fees?

  1. Facilities manufacturing, or intending to manufacture, API of human generic drugs and/or finished dosage form (FDF) human generic drugs.
  2. Facilities that engage in generic drug packaging and labeling (FDA consider these as manufacturing facilities)

Who does not require to pay the fees?

  1. Firms that engages in testing, repackaging or relabeling are not required to pay the fees.

Penalty for not submitting Self– Identification

  1. Under GDUFA, all FDF or API products manufactured at the facility will be considered as misbranded. 
  2. Products manufactured in foreign facilities are considered misbranded and it is a violation of federal law to market misbranded products in interstate commerce or to import the products into the United States.

Drug manufacturers’ needs to submit their Self – Identification information to FDA through Electronic Submission Gateway (ESG) by creating Structured Product Labeling (SPL) files.

For FY 2019, the Self-Identification period starts from May 1st 2019 to June 1st 2019.

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

Sudhs S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

BASICS OF IMPORTATION – MEDICAL DEVICES

FDA regulates a range of products which includes food (human and animal consumption), medical products (drugs, devices and biological products), radiation-emitting electronic products, tobacco products and cosmetics. All imported shipments of FDA regulated products are evaluated by FDA and needs to comply with same regulations as of domestic products.  The products that are offered into U.S including personal items must be declared to U.S. Customs and Border Protection (CBP). CBP will refers all FDA –regulated products to FDA for review. Mostly, importers will hire a custom broker to help them in submitting necessary entry documents and applicable payments to CBP on behalf of the importer.  FDA regulated products are refused to enter in US commerce, if they appear to be adulterated, misbranded, or restricted for Sale.   Refused products needs to be destroyed or exported from U.S within 90 days.

MEDICAL DEVICE IMPORTATION

Foreign medical device manufacturers are required to meet applicable US FDA medical device regulations in order to import devices into the U.S although the product is permitted for marketing in another country.  The following are the requirements which FDA checks at the time of importation

  1. Medical device establishment registration
  2. Device listing
  3. Medical Device Labeling
  4. Premarket Notification(510K) or Premarket approval(PMA) if applicable
  5. GMP Regulations
  6. U.S Agent for foreign manufacturers.

The Initial importer of the device are required to register their establishment with FDA.

As per FDA, an initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.  FDA medical device establishment registration and listing can be found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Manufacturers, Initial importers and device user facilities are subject to Medical Device Reporting (MDR) regulation, where they have to report device-related adverse events and problems to FDA. Importers are required to maintain a MDR event file for each adverse event and also they have to forward all product complaints (MDR and non MDR events) to the manufacturer.

Medical devices that are imported into the United States must meet Custom Border Protection (CBP) requirements in addition to FDA regulations.

Liberty Management Group, a leading FDA consulting group in the United States provides assistance with medical device establishment registration, device listing, medical device label review and US agent service for foreign medical device establishment firms.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us