Month: March 2024

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