CERTIFICATE TO PHARMACEUTICAL PRODUCT (CPP)

A Certificate of Pharmaceutical Product (CPP) is an internationally recognized document that confirms the marketing status and regulatory compliance of a pharmaceutical product. FDA is issuing it to facilitate export of FDA-regulated products from the United States.

The CPP provides information about the product, such as the product name, dosage form, strength, manufacturer, and the regulatory status in the country of origin. It serves as evidence that the product is authorized for sale in the country of origin and meets the regulatory requirements for quality, safety, and efficacy.

Foreign governments are seeking official assurance that products exported from the United States to their countries can be marketed in the United States or meet specific U.S. regulations, such as current good manufacturing practice (CGMP) regulations. A foreign government may also require export certification as part of the process register or import a product into that country.

To obtain a CPP, the pharmaceutical manufacturer must apply to FDA where the product is authorized for sale. The application must include information about the product, its regulatory status, and the intended recipient country. FDA will review the application and issue the CPP if the product is deemed to follow their regulations.

It is important to note that the requirements for obtaining a CPP may vary between countries and regions. Some countries may require additional documentation or information, while others may not recognize the CPP at all.

Requirements to get the Certificate to Pharmaceutical Product (CPP)

  1. The manufacturing facility must have a valid drug establishment registration.
  2. All drugs must be listed with FDA.
  3. The drugs should meet all the drug labelling requirements as per 21 CFR 201.
  4. The drugs should be manufactured in accordance with 21CFR 210 also known as Good Manufacturing practice.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA drug establishment registration, drug listing and certificate to Pharmaceutical Product.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

PRIVATE LABEL DISTRIBUTOR

A firm that does not participate in the manufacture or processing of a drug but markets and distributes under its own trade/brand name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.

The private label distributor takes on the responsibility of marketing, branding, and selling the products, while the manufacturer is responsible for producing and supplying the products.

PLDs do not have a registration or listing obligation for drugs since they do not manufacture or process in their facility.

They may elect to submit listing information for a drug they do not manufacture or process directly to the FDA by themselves or if they do not want to list, the manufacturer must submit the drug listings on behalf of the private label distributor.

If the PLD submit the listings under their NDC number, they assume full responsibility for compliance with all listing requirements.

To be a successful private label distributor, it is important to have strong relationships with manufacturers, a clear understanding of market trends and consumer preferences, and effective branding and marketing strategies.

The steps involved in drug listings can be checked at https://www.fdahelp.us/otc-drug-registration-process-fda.html

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

UDI REQUIREMENT FOR CLASS I MEDICAL DEVICES

The Unique Device Identification (UDI) system is a globally recognized system for identifying and tracking medical devices throughout their distribution and use. It was established by the US Food and Drug Administration (FDA) to enhance patient safety and improve the efficiency of medical device recalls.

For class 1 medical devices, which are considered low risk devices, the UDI requirements are more flexible than for higher risk devices. Class 1 devices are exempt from the requirement to include a UDI on the device label if they are exempt from GMP regulations.

FDA has categorized Class 1 devices in two categories.

  1. Class 1 devices that are considered as consumer health products.
  2. Class 1 devices that are not considered as consumer health products.

Class 1 devices that are considered as consumer health products are the devices that pose the lowest risk of which many are 510(k)-exempt devices are sold directly to consumers over-the-counter in retail and online stores. Since these devices pose the lowest risk, FDA does not intend to enforce GUDID submission requirements under consumer health products.

Class 1 devices that are not considered as consumer health products are the devices that are typically used in healthcare settings and are often subject to additional regulatory controls, such as 510k submission. Submission of UDI for these devices will be helpful in reducing medical errors and simplify the integration of device use information into data systems.

Below are the compliance dates for class I medical devices.

Device Type Compliance Date
Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI September 24, 2022
Class I and unclassified devices, other than I/LS/LS devices September 24, 2022
Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI December 8, 2022

The UDI for class 1 medical devices must be in a human-readable format and a machine-readable format, such as a barcode or RFID tag. The UDI must also be submitted to the FDA’s Global Unique Device Identification Database (GUDID), which is a publicly accessible database that contains information on medical devices.

The UDI system helps to ensure the safety and effectiveness of medical devices by enabling more accurate tracking and monitoring of these products throughout their lifecycle.

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with UDI account creation, selection of Accrediting agency, GUDID submission.

Sudha S

Regulatory Consultant

WWW.fdahelp.us

Email: Office@libertymanagement.us

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