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Showing 101–108 of 108 regulations
Implantation or Injectable Dosage Form New Animal Drugs
21 CFR Part 522 establishes specifications, sponsors, and conditions of use for injectable and implantation dosage form new animal drugs including acepromazine (tranquilizer/preanesthetic), alfaxalone (anesthetic), amikacin (antibiotic), and aminopentamide (anti-emetic/anti-diarrheal). Each drug section specifies dosage amounts for target species, indications for use, and limitations including veterinary-only restrictions and controlled substance designations where applicable.
Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
21 CFR Part 1301 establishes registration procedures for manufacturers, distributors, dispensers, importers, and exporters of controlled substances under the Controlled Substances Act. Every person engaged in these activities must obtain DEA registration unless exempt. Online pharmacies must obtain a modified registration to dispense controlled substances via the Internet. Separate registrations are required for each principal place of business where such activities occur.
Prescriptions
21 CFR Part 1306 establishes procedures for prescribing and dispensing controlled substances to patients. It defines who may issue prescriptions (authorized individual practitioners), requires prescriptions be issued for legitimate medical purposes in the usual course of professional practice, and sets forth prescription format requirements including patient/practitioner information and drug details. Special provisions apply to Schedule III-V narcotic drugs used for maintenance or detoxification treatment.
Records and Reports of Registrants
21 CFR Part 1304 establishes recordkeeping and reporting requirements for registrants under the Controlled Substances Act, including manufacturers, distributors, importers, researchers, and practitioners. Registrants must maintain inventories and file reports as required by the Act; individual practitioners have limited recordkeeping obligations except for maintenance or detoxification treatments. Records may be consolidated into one system covering all controlled substance activities conducted under a single registration.
Orders for Schedule I and II Controlled Substances
This regulation establishes procedures for ordering Schedule I and II controlled substances under the Controlled Substances Act. It specifies who may obtain DEA Form 222 or issue electronic orders (registered persons only), exemptions from ordering requirements, and authorization procedures including power of attorney provisions for agents to execute orders on behalf of registrants.
Additional Standards for Diagnostic Substances for Laboratory Tests
21 CFR Part 660 establishes additional standards for diagnostic substances used in laboratory tests, specifically covering antibody to hepatitis B surface antigen. The regulation defines proper sourcing from immunized animal plasma/blood or hepatitis B surface antigen-positive human donors, specifies processing methods to ensure specificity and potency, and mandates labeling requirements including source indication, test method recommendations, and hepatitis transmission warnings. Ancillary reagents must meet purity standards and be manufactured to prevent contamination.
New Animal Drug Applications
21 CFR Part 514 establishes procedures for submitting New Animal Drug Applications (NADAs) to the FDA. Applications must be filed in triplicate and include detailed identification, chemistry data, scientific rationale, clinical and laboratory study summaries, labeling, and other supporting information as appropriate. Applications must be signed by the applicant or authorized U.S. representative and may reference prior FDA submissions if specifically identified and authorized.
Tolerances for Residues of New Animal Drugs in Food
21 CFR Part 556 establishes tolerances for residues of new animal drugs in food. The regulation requires applicants to submit proposed tolerances when seeking approval of new animal drugs for food-producing animals. Tolerances are set based on acceptable daily intake (ADI) and acute reference dose (ARfD) to ensure consumer safety, with residue limits codified for approved and conditionally approved drugs.