Month: May 2023

Drug Master File (DMF)

A Drug Master File (DMF) is a confidential submission to FDA to provide detailed information about the facilities, processes or articles used to manufacture, process, package or store human drugs.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. It is submitted by a drug manufacturer to provide confidential information about the drug’s quality, safety, and efficacy. The information submitted in a DMF is usually referenced only during the IND, NDA, ANDA or export application. A DMF contains technical information about a drug, including its chemical and physical properties, manufacturing processes, and analytical methods.

DMFs are often submitted by drug manufacturers to support the approval of their drug products. DMFs are subject to strict confidentiality requirements and are not publicly available.

DMF holders are required to notify FDA of any changes in the contents of DMF, authorized parties, transfer of ownership etc. An annual report must be submitted every year listing all changes since the previous annual report. Foreign DMF holders are required to appoint a US Agent in their submissions.

Types of Drug Master Files

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information

Liberty Management Group Ltd. can help you with DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

MOCRA – Modernization of Cosmetics Regulation Act of 2022

Recently US Congress passed the Consolidated Appropriations Act, bringing changes to how cosmetic products are regulated in the US. MOCRA or the Modernization of Cosmetics Regulation Act of 2022 provides regulatory authority to US FDA over cosmetic industry. Key requirements of MOCRA are as below:

Manufacturers and processors must register their facilities with the FDA and renew such registration biennially. FDA no longer accepts VCRP registrations so Facilities that were registered under the VCRP program will have to register again under the new system.

A responsible person must list each marketed cosmetic product and ingredients with the FDA and must renew such listing annually.

  • Good Manufacturing Practices (GMP)

Cosmetic manufacturing and processing facilities must comply with GMP standards.

Cosmetic product labels must adhere to new cosmetic labeling requirements.

  • Adverse Event Report

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the US to the FDA. FDA will have access to adverse event reports during an inspection.

  • Product Safety Substantiation

A responsible person is required to ensure and maintain records supporting adequate safety               substantiation for their products.

  • Mandatory Recall

FDA has the authority to order a mandatory recall, if deemed necessary, if the responsible person refuses to do so voluntarily.

A responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Liberty Management Group Ltd. can help you with Facility Registration, Product Listing, Label compliance and other FDA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us