Tag: FDA Drug Registration

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

DRUG LISTING

All domestic or foreign establishments that manufactures or commercially distributes human drug and animal products within the U.S., you are subject to drug establishment registration and drug listing requirements. Establishment Registration and drug listings lets FDA to develop and maintain a catalog of all drug products marketed in the U.S. Registration information provides the locations and contact information for drug establishments and determines sites for inspection. Drug product listing information provides an inventory of all drug products in the market with manufacturing information, which includes inactive ingredients incorporated into marketed drug products. The FDA depends on this registration and listing information for controlling key programs, including post-marketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application. The electronic drug establishment registration and drug listing system (eDRLS) also populates electronic listing databases such as DailyMed and the National Drug Code (NDC) Directory, improving the accuracy and inclusiveness of these databases.

Drug establishments (manufacturers/contract manufacturers, re-packagers, re-labelers) – domestic and foreign – must register with the US FDA and list their products.

There is no registration requirement for Private Label distributors, but they must list their products under their own NDC number.

Listing can be done electronically via ESG portal or FDA’s CDER direct.

Listings must be updated every June and December, or sooner if there are any changes. There is also an annual renewal period (October 1 to December 31) for certification which is called No-change certification (Blanket listing submission)

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

U.S AGENT

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a food, drug, medical device, and cosmetics imported into the United States must identify a U.S. agent for that establishment.

Information about a foreign establishment’s U.S. Agent must be electronically using the FDA FURLS system or CDER/ESG and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment should provide the name, address, telephone, and e-mail address of the U.S. agent.

Responsibilities of a U.S. agent

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S and they cannot use P.O. BOX as the address. U.S agents must be available to answer the phone or have an employee available to answer the phone during normal business hours.

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

  • Assisting FDA in communications with the foreign establishment, meaning that function as a mediator between the client and the FDA.
  • Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States,
  • Assisting FDA in scheduling inspections of the foreign establishment and
  • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Liberty Management Group, a leading FDA consulting firm provides assistance with US agent services all foreign food, drug, medical devices and cosmetics establishments.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

WHO NEEDS TO REGISTER WITH FDA?

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, biological products, medical devices, food (including animal food), cosmetics, and tobacco products. It also regulates electronic products that emit radiation.

Foods:

The FDA regulates the safety, labeling, and quality of all other food products except for meat, poultry, and egg products, which are regulated by the US Department of Agriculture (USDA).

In general, it includes Fresh and processed foods, Dietary supplements, Bottled water, Food additives, Infant formulas, fruits, and vegetables.

Drugs:

The FDA regulates the safety, effectiveness, and quality of all human and animal drugs, which includes prescription and over-the-counter drugs, homeopathic drugs, active pharmaceutical ingredients and vaccines and other biological products.

Medical Devices:

The FDA regulates the safety, effectiveness, and quality of all medical devices used in humans which includes a wide range of devices, from simple bandages to complex surgical implants.

Cosmetics:

The FDA regulates the safety of all cosmetics, including makeup, skincare products, and hair care products, Hair care products, lotions, and moisturizers.

Products are categorized based on the label claims and regulated according to intended use.

Liberty Management Group Ltd, as a leading FDA consulting firm providing assistance with FDA registration of food, drug, medical devices and cosmetic products.

Liberty Management Group Ltd, as a leading FDA consulting firm will provide assistance with above all regulatory requirements.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

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

COSMETIC OR DRUG

The classification of a product as a cosmetic or a drug by the U.S. FDA depends on its intended use of the product and how it is marketed. The products are regulated differently based on the classification.

Cosmetic:

As per FDA, a cosmetic is defined as a product “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body’s structure or functions.” Examples include skin moisturizers, perfumes, body cleansers, haircare products, moisturizers, and other skincare products.

FDA has introduced a new regulation under Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for registering the manufacturing facility with FDA and doing product listings.

Drug:

A drug is defined as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body.” This includes over the counter (OTC) medications, prescription drugs, and even some products marketed as dietary supplements.

Drugs are subject to more stringent regulatory requirements, including pre-market approval processes. They must demonstrate safety and efficacy before being allowed on the market.

It’s important to note that the intended use of a product, as determined by its marketing claims, is a key factor in determining its regulatory classification. If a product is intended to cleanse, beautify, or enhance appearance without making drug claims, it is likely to be classified as a cosmetic. If the product claims to treat or prevent a specific condition or disease, it may be classified as a drug.

However, some products, known as “cosmeceuticals,” may have characteristics of both cosmetics and drugs. These products claim to have therapeutic benefits but are often marketed as cosmetics. The classification can sometimes be nuanced, and companies must carefully consider their product claims and formulations to ensure compliance with FDA regulations.

If a product is classified as drug, then it must comply with all applicable drug regulations including establishment registration, cGMP and drug listing.

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