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The labeling of animal drugs in the marketplace now includes the statement "Approved by FDA" as required by amendments in the Animal Drug User Fee Act and Animal Generic Drug User Fee Act of 2018. This statement helps veterinarians, pet owners, and animal producers identify FDA-approved drugs and distinguish them from drugs without FDA approval. The FDA's approval ensures that the drugs are safe, effective, properly manufactured, and adequately labeled and packaged. All FDA-approved animal drugs have a New Animal Drug Application number or an Abbreviated New Animal Drug Application number, which must be included in the labeling. Drugs without the "Approved by FDA" statement are considered misbranded, and distributing them violates the law. However, very small labeling components and individual ingredients used to manufacture certain animal drugs are exempt from this requirement. The FDA has been working with drug sponsors to update the labeling of all approved animal drugs since the requirement was implemented. The labeling for Type A medicated articles and proprietary medicated feeds must also include the "Approved by FDA" statement. [Extracted from the article]

FDA believes that given their specialized training and experience, veterinarians play a critical role in antimicrobial stewardship and can help reduce the risks of antimicrobial resistance. The U.S. Food and Drug Administration (FDA) announced this week the successful implementation of guidance for industry (GFI) #263, "Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.". [Extracted from the article]

"This case is an example of how seriously the United States Attorney's Office takes the distribution of misbranded prescription drugs, whether for human or animal consumption, said United States Attorney Christopher R. Kavanaugh. Midwest Veterinary Supply, a Minnesota-based company that supplies prescription drugs for animals to veterinarians, farms, feedlots and other businesses, was sentenced to one year of probation for introducing misbranded drugs into interstate commerce. According to court documents, from 2011-2021, Midwest charged and shipped over $10 million in prescription drugs from their non-pharmacy locations throughout the United States to end-users that were not authorized to receive prescription drugs. [Extracted from the article]

For a veterinarian to legally sell or prescribe prescription products, FDA states, "A licensed veterinarian may legally use or dispense a prescription animal drug only within the course of her/his professional practice where a valid veterinarian-client-patient relationship exists. On June 11th, 2021, The Food and Drug Administration (FDA) finalized a Guidance for Industry (GFI) #263, which outlines the process for animal drug manufacturers to change all remaining antibiotic formulations used in animal health care from over-the-counter (OTC) to prescription status. Graph Once the VCPR is established and recognized by both the client and the veterinarian, then the discussions can begin regarding how to obtain prescription antibiotics after June 2023. [Extracted from the article]

Many antibiotics went through a similar transition in 2017, when FDA focused on feed antibiotics and OTC antibiotics delivered in the water. Veterinarians are getting their prescription pads ready as farmers will need them for several antibiotics used to treat livestock starting in mid-June. [Extracted from the article]

This switch should prompt positive producer-veterinarian conversations that allow for revisiting animal health treatment protocols. Now is the time to plan for a smooth transition, and Zoetis is actively working with veterinarians and producers in this time of change to help ensure continued access to the company's animal health products. Livestock producers will start noticing a change in how they access specific antimicrobial products, as some products will be switching from over-the-counter (OTC) to prescription (Rx) only status as a result of U.S. Food and Drug Administration (FDA) Guidance for Industry (GFI) #263. [Extracted from the article]

For example, cattle that are implanted have a 10 to 15% increase in ADG when compared with cattle that are not implanted and an 8 to 12% increase in FE. Although it may seem that many cattle producers are JUST hearing that changes to implant protocols may be coming, the reality is that FDA GFI #191 was first released in August of 2020, and in May of 2021 a letter was drafted to inform the industry that implant labels would be under review. One example of this could be: One implant given in the "beef calf phase" (perhaps, Ralgro), one implant in the "growing beef steers/heifers on pasture phase" (perhaps, Revalor-G), and one implant in the "growing beef steers/heifers in confinement fed for slaughter phase" (perhaps, Revalor-XS or Revalor-XH). [Extracted from the article]

In this method, a biomass denominator adjusts annual antimicrobial sales data to account for the size of the population of a given livestock species in the U.S. potentially being treated with those drugs. The U.S. Food and Drug Administration has launched an Interactive Summary of Biomass-Adjusted Antimicrobial Sales Data. [Extracted from the article]

The American Veterinary Medical Association has new or revised policies on raw milk, use of prescription drugs, reporting of adverse events, genetic modification of animals in agriculture, and approval and availability of antimicrobials for food-producing animals. The AVMA Food Safety Advisory Committee reviewed the AVMA policy on "Raw Milk" and proposed revisions for clarity and accuracy, and the HOD made a few tweaks to be further explicit. [Extracted from the article]

The inspection closed with nil observations [ABSTRACT FROM AUTHOR]

Fundamental to the WOAH's global approach of data collection and evaluation of antimicrobial use in animals is to advance the One Health agenda, together with its partners. Partially a natural process, antimicrobial resistance can be greatly accelerated by the overuse or misuse of antimicrobials, which the WOAH explains can exert selective pressure for pathogens with resistance traits to survive and thrive. The use of antimicrobials in animals across the world has shown an overall decrease of 27% between 2016 and 2018, according to the data reported to the World Organization for Animal Health (WOAH, founded as OIE). [Extracted from the article]

Although the public may submit comments on any FDA guidance document at any time, the agency suggests comments on the draft guidance be submitted within 60 days to ensure that it considers the comment(s) before it begins work on the final version of the guidance document. The document provides guidance to animal drug sponsors on specific areas of the approval process where the available scientific literature may be useful to support the approval of a new animal drug application, an abbreviated new animal drug application, or a conditionally approved new animal drug application. [Extracted from the article]

FDA said it believes good antimicrobial stewardship practices in animals helps slow the development of antimicrobial resistance and preserve the effectiveness of these drugs in both humans and animals. The U.S. Food and Drug Administration has finalized guidance for industry (GFI) #263 to outline the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx). [Extracted from the article]

This means that FDA determines that the IGA is safe for the animal, safe to anyone that eats food derived from the animal, and that it is "effective", i.e. it does what the developer claims it will do. The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) is announcing an Animal Biotechnology Stakeholder Outreach Session that will be open to the public and will take place virtually on Wednesday, July 28 from 3:40 - 4:45 PM ET (2:40 - 3:45p.m. [Extracted from the article]

Hahn noted that FDA is aware of how this action may affect other FDA responsibilities, including product application reviews. FDA said when it is temporarily not able to physically inspect foreign-produced, FDA-regulated products or manufacturers, it plans, as an interim measure, to employ additional tools to ensure the safety of products imported into the U.S., which have proved effective in the past. [Extracted from the article]

In September, the Food and Drug Administration Center for Veterinary Medicine (FDA CVM) released draft Guidance for Industry (GFI) document No. 263 for comment. GFI No. 213 also outlined the process for moving the remaining in-feed antibiotic labels for medically important antibiotics to require a VFD, as well as moving all labels for medically important antibiotics administered through the water to require a prescription. Both GFI No. 213 and GFI No. 263 stem from the principles outlined in yet another GFI document, GFI No. 209, finalized in 2012: "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.". [Extracted from the article]

The article discusses the results of the evaluation and the re-evaluation of some veterinary drugs conducted by the Joint FOA/WHO Expert Committee on Food Additives. Among the drugs that have been analyzed include Colistin, Erythromycin, Flumequine, and Ractopamine hydrochloride. Information regarding the results of the drug analysis is discussed.

The article discusses the general regulations to be followed with regards to the evaluation of veterinary drugs as stipulated within the terms of reference set by the Joint FOA/WHO Expert Committee on Food Additives. Such regulations have been carried out basing from the recommendations that were suggested during the Bangkok workshop as well as the draft paper that was prepared by the Codex Committee on Residues of Veterinary Drugs in Foods.

Comments on chloramphenical found at low levels in animal products, as discussed at the meeting of the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives in Rome, Italy from February 2 to 4, 2004. Concern about the genotoxicity of chloramphenicol and its metabolites; Embryo- and fetotoxicity; Carcinogenic potential in humans; Lack of a dose-response relationship for aplastic anemia in humans; Assessment of carcinogenicity and effecs on reproduction.

Comments on the residues of specific veterinary drugs, as discussed at the meeting of the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives in Rome, Italy from February 2 to 4, 2004. Cefuroxime; Cyhalothrin; Cypermethrin and alpha-cypermethrin; Doramectin; Flumequine; Lincomycin; Melengestrol acetate; Phoxim.

FDA's new guidance for industry proposal on compounding drugs is not faring well in an industry survey. In FDA's request for public comment, it says the draft guidance would advise veterinarians on circumstances under which the FDA does not plan to take action for certain violations of the Federal Food, Drug, and Cosmetic Act when pharmacists and veterinarians compound animal drugs from bulk drug substances. [Extracted from the article]

The latest in a line of initiatives to increase veterinary oversight of medically important antimicrobials has been released by the Food and Drug Administration Center for Veterinary Medicine (CVM). CVM has now released draft GFI No. 263 to further advance Principle No. 2 in GFI No. 209 and also mesh with the intent stated in the CVM five-year action plan. This includes commonly used products such as procaine penicillin G, procaine-benzathine penicillin G, oxytetracycline, tylosin and OTC antimicrobial intramammary tubes for mastitis. [Extracted from the article]

The article focuses on the use of antibiotics in food producing animals. The past U.S. Congresses have introduced legislation to restrict the use of some antibiotics in animals. The U.S. Food and Drug Administration (FDA) evaluates human and animal drugs for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act.

The article discusses the importance of approval through Veterinary Feed Directive (VFD) in case of administering medically important antibiotics to cattle and importance of communication between veterinarian, producer and VFD drug distributor.

The article discusses the four steps that beef producers could take to prepare for the implementation of the Veterinary Feed Directive (VFD), which will take effect in the U.S. starting January 1, 2017.

An introduction is presented in which the editor discusses various reports within the issue on topics including outbreaks of foodborne illnesses, requirements on the use of animal drugs and pesticides, and understanding on-farm food safety.

Highlights the recommendations made by the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives at its meeting in Rome, Italy from February 2 to 4, 2004. Potential public health consequences identified in the report; Recommendations relating to specific veterinary drugs; Establishment of a group acceptable daily intake for cypermethrin and alpha-cypermethrin.