Month: October 2023

HOMEOPATHIC DRUG REGISTRATION

Homeopathic drugs are regulated differently from conventional drugs, and the regulatory framework has been shaped by the Food, Drug, and Cosmetic Act (FD&C Act) and the Homeopathic Pharmacopoeia of the United States (HPUS).

Homeopathic drugs are subject to the provisions of the FD&C Act, which outlines the legal requirements for safety, efficacy, and labeling of drugs. The FDA recognizes the HPUS as the official compendium for homeopathic drugs in the United States. The HPUS provides standards for the preparation, quality, and labeling of homeopathic products.

Homeopathic drugs must comply with certain labeling requirements, including disclosure of ingredients, indications, and proper dilution information. However, the labeling standards for homeopathic drugs may differ from those for conventional drugs.

Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

DRUG LISTING RENEWALS

Drug listing is an important regulatory requirement that helps the FDA track and monitor all drugs, including over the counter (OTC) drugs, prescription drugs, and other pharmaceutical products marketed in the United States. Drug listing renewals ensure that the FDA has accurate and up-to-date information about each drug product.

Here are the key points regarding FDA drug listing renewal:

  1. Annual Renewal: Drug listing information must be updated with the FDA annually. The renewal must be completed between October 1st and December 31st of each year for the following year .
  2. Electronic Submission: Drug listing renewal must be completed electronically through the FDA’s Electronic Submissions Gateway (ESG) or CDER direct.
  3. Information Updates: During the renewal process, drug manufacturers or sponsors are required to review and update the information related to their drug products, which includes information such as product formulation, labeling, manufacturer information, and establishment registration.
  4. Consequences of Non-Renewal: Failure to renew drug listings can have serious regulatory consequences. Any drug listing that is required to be certified but is not certified may be considered inactive and removed from the NDC Directory and other publications of listing data.
  5. NDC Assignment: The National Drug Code (NDC) is an essential part of drug listing. Manufacturers should ensure that the NDCs for their drug products are accurate and up to date while renewing their listings.

Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listing renewals and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email : Office@libertymanagement.us

www.fdahelp.us