Search Results for keywords:"Federal Food Drug and Cosmetic Act"

The Food and Drug Administration (FDA) has made available a final guidance document titled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates a previous version and includes a list known as the 506J Device List, which outlines device product codes that manufacturers must notify the FDA about if they stop production. The document clarifies that manufacturers can also voluntarily notify the FDA of any supply chain issues, regardless of public health emergencies. This guidance aims to facilitate continuous device supply and prevent shortages.

The FDA has issued a final debarment order against Alnashir Alibhai Punjani, prohibiting him from importing or attempting to import any drugs into the U.S. for five years. This decision is because Mr. Punjani was found guilty of conspiring to import and sell unapproved drugs. The drugs he imported and resold contained sildenafil, an ingredient used in Viagra, and were not approved by the FDA, raising potential health risks. Mr. Punjani did not respond to the notice of debarment, waiving his right to contest the decision.

The Food and Drug Administration (FDA) has decided to deny Yong Sheng Jiao's request for a hearing and issued a final debarment order. Jiao, who pleaded guilty to felony charges related to importing a misbranded drug into the U.S., is barred for five years from providing services connected to drug application processes. The FDA determined that the seriousness of Jiao's offense warranted this punishment, despite Jiao's claims of misunderstanding and attempts to challenge the penalty's severity. The decision reflects the FDA's commitment to maintaining the safety and integrity of the drug industry in the United States.

The Environmental Protection Agency (EPA) has established a rule allowing a specific level of the pesticide ethiprole on imported sugarcane, upon request from Bayer CropScience LP, in accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA). The rule, effective from December 27, 2024, sets a maximum residue level of 0.07 parts per million. This comes after a review showing no expected harm to the general public, including infants and children, from exposure to this pesticide. The rule does not require any proposed rule issuance, nor does it impact states or tribal governments.

The Environmental Protection Agency (EPA) has issued a final rule that amends the existing exemption for residues of Complex Polymeric Polyhydroxy Acids (CPPA). This change allows CPPA to be used not only as a plant growth regulator but also as a nematicide, which is a type of pesticide that kills nematodes. The EPA concluded that the use of CPPA, when applied following proper practices, presents no risk to the U.S. population, including infants and children. This decision follows a petition by FBSciences, Inc. and upholds safety standards set under the Federal Food, Drug, and Cosmetic Act.

The Environmental Protection Agency (EPA) has established new regulations for residues of the herbicide clopyralid on certain agricultural products, such as caneberries, bulb onions, and intermediate wheatgrass. These regulations are part of the Federal Food, Drug, and Cosmetic Act and are intended to ensure that residue levels are safe for human consumption. The EPA assessed the safety of clopyralid residues and found no significant risk to the general population, including infants and children. No international residue limits have been set for clopyralid, and this regulation directly impacts growers, food processors, and retailers but does not affect states, tribal governments, or impose unfunded mandates.

The Food and Drug Administration (FDA) has released a new guidance document for the industry titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This document establishes the conditions for compounding certain drugs and explains the FDA’s current approach while developing a list of bulk drug substances permitted for use. This guidance replaces a previous version from 2017 and provides instructions on submitting comments to the FDA. The guidance clearly states it is not legally binding but shows the FDA's current thinking on this issue.

The Food and Drug Administration (FDA) has released a draft guidance for industry on the process of notifying them about a permanent discontinuance or an interruption in the manufacture of infant formula. This guidance aims to assist those in the infant formula industry in complying with notification requirements to the FDA, as mandated under the Federal Food, Drug, and Cosmetic Act. The guidance outlines how and when manufacturers should notify the FDA in order to avoid potential disruptions in supply. The public is invited to submit comments on the draft guidance until February 18, 2025, and on the proposed collection of information by February 3, 2025.

The Food and Drug Administration (FDA) has decided to withdraw its approval of 23 abbreviated new drug applications (ANDAs) after being informed by the applicants that these drug products are no longer being marketed. This withdrawal is effective from February 14, 2025. The applicants have waived their right to a hearing regarding this decision. According to the regulations, any remaining inventory of these products can be dispensed until it runs out, expires, or otherwise becomes non-compliant.

The Food and Drug Administration (FDA) has issued a final order denying Bernardo Garmendia's request for a hearing and has permanently banned him from providing services related to drug products. This decision stems from Garmendia's conviction for conspiracy to commit wire fraud while working at AMB Research Center, where he was involved in falsifying clinical trial documents. As of March 14, 2025, using Garmendia’s services in any drug application process incurs civil penalties for involved parties. This ruling highlights the FDA's commitment to safeguarding drug development processes.