Search Results for keywords:"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 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 announced the availability of a final guidance titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance details FDA's temporary rules for licensed pharmacists and physicians who are compounding drugs using bulk substances, while the agency works on creating a list of approved substances. The updated guidance finalizes the draft that was issued in December 2023 and replaces the previous 2017 guidance, ending the categorization of substances into different groups and outlining conditions under which the FDA will not take action against compounding that does not meet full compliance, while the list is still being developed. This guidance is issued as part of FDA's regulatory framework, but it does not establish any binding rights or obligations.

The Environmental Protection Agency (EPA) has established tolerances for the pesticide streptomycin on specific citrus fruits and their dried pulp. These new limits are set for residues of the fungicide in the citrus group 10-10 at 0.8 ppm and in dried pulp at 3 ppm, based on a petition by Geo Logic Corporation. The EPA has reviewed data and determined that the new tolerances are safe for consumption by the general population, including infants and children, with no expected harmful effects. Additionally, the tolerances for some other commodities related to streptomycin have been updated or removed, reflecting changes due to expired protections or data updates.

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 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 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 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 issued an order permanently banning Jerrod Nichols Smith from providing services related to drug product applications. This decision follows his conviction on multiple felony counts of mail fraud and obstruction of justice, connected with the unlawful distribution and misrepresentation of prescription drugs. Smith's company, Cumberland Distribution, was involved in distributing drugs illegally obtained from unlicensed sources, leading to significant profit from falsified documents and drug mislabeling. After being notified, Smith did not respond or request a hearing, resulting in his debarment which prohibits him from engaging in drug product services.

The Food and Drug Administration (FDA) has issued a priority review voucher to PTC Therapeutics Inc. for their product, KEBILIDI (eladocagene exuparvovec-tneq). This product is designed to treat both adult and pediatric patients with a condition known as aromatic L-amino acid decarboxylase deficiency. The priority review voucher is awarded under the Rare Pediatric Disease program, which encourages the development of treatments for rare diseases affecting children. The FDA is required to announce when such vouchers are given, as part of the criteria set by the Federal Food, Drug, and Cosmetic Act.