美国FDA禁止动物生产中使用的24种抗生素
Guidance for Industry #213, "New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209" (GFI #213) lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of affected products to remove production indications. The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight.Once manufacturers voluntarily make these changes, these medically important antimicrobial drugs can no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight.
A list of applications initially affected by GFI #213 is provided below. The list categorizes applications either as Pioneer, Generic, or Combination, which are described as follows:
Pioneer – A pioneer or original new animal drug application (NADA).
Generic - An abbreviated (generic) new animal drug application (ANADA) that references a single ingredient NADA application.
Combination – A combination new animal drug application (NADA or ANADA) that references several single ingredient NADA applications.
Revisions to the approved conditions of use in NADAs for pioneer products
will affect the conditions of use in generic or combination applications
that reference these pioneer applications. When pioneer applications are
revised, FDA will work expeditiously with sponsors to align the generic
and combination applications with the revised conditions of use in the
pioneer (i.e., reference) applications.
泰乐，林可，土霉，大观，四环，维吉，安普，链霉，红霉，金霉，青霉，新霉，
潮霉，盐霉，莫能，拉洛，庆大，杆菌，伊维，泰妙，生度，甲盐，竹霉，碳霉
这些产品的有关的中国生产企业势必受到影响。
English
