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CCH NetNews™ |
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(July 13, 2010)
Food and Drug Law |
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The precursor chemical, 4-anilino-N-phenethyl-4-piperidine (ANPP) will be designated by the Drug Enforcement Administration (DEA) as an immediate precursor for the Schedule II controlled substance fentanyl and listed as a Schedule II substance under the Controlled Substances Act. According to the DEA, ANPP is the immediate chemical intermediary in the synthesis process currently used by laboratory operators for the illicit manufacture of fentanyl. As a schedule II substance, ANPP will be safeguarded to the same degree that pharmaceutical firms now safeguard the fentanyl produced. The final rule is effective August 30, 2010.
FDA Order.Read IRN» (ip access user) » (Read Intelliconnect) »
Regulations which list the substances benzylfentanyl and thenylfentanyl as being temporarily subject to Schedule I controls under the emergency scheduling provisions of the Controlled Substances Act were removed by the Drug Enforcement Administration (DEA) because both compounds are essentially inactive, with no evidence of abuse potential. Both of these substances were temporarily controlled because they were initially found in street samples with other fentanyl analogues and were most likely unreacted intermediates in the synthesis of the target fentanyl analogues. As such, these compounds are no longer Schedule I controlled substances and all references to these compounds are being deleted from DEA regulations. The final rule is effective immediately.
FDA Order.Read IRN» (ip access user) » (Read Intelliconnect) »
A draft guidance with the FDA’s recommendations on the use of medically important antimicrobial drugs in food-producing animals has been published by the agency. Titled “The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals, ” the draft guidance summarizes key scientific reports on the use of antimicrobial drugs in animal agriculture and outlines the FDA’s current thinking on strategies for assuring that medically important antimicrobial drugs are used judiciously in food-producing animals in order to help minimize antimicrobial resistance development. The FDA is recommending two additional principles about the appropriate or judicious use of medically important antimicrobial drugs in food-producing animals: (1) ones considered necessary for assuring animal health; and (2) ones including veterinary oversight or consultation.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
A 90-day comment extension regarding potential changes to current regulations on veterinary feed directive (VFD) drugs was announced by the FDA. The comment period was opened after the agency noted it has received a number of informal general comments that characterized the current VFD process as being overly burdensome. Comments on VFD drugs were requested, specifically regarding: (1) conditions that must be met by veterinarians issuing a VFD; (2) what veterinarians must do with a VFD, e.g., disposition of original VFD and copies; (3) records that must be kept related to the VFDs; (4) notification requirements for distributors of animal feeds containing a VFD drug; (5) additional record keeping requirements that apply to distributors; (6) cautionary statements required for VFD drugs and animal feeds containing VFD drugs; and (7) any other topics. Comments may be submitted until August 27, 2010.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
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