Bctal Pharmacy Tech Review: Laws

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Pure Food and Drug Act of 1906

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Prohibits the interstate transportation or sale of adulterated and misbranded food or drugs.

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Food, Drug, and Cosmetic Act of 1938 (FDCA)

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Defined adulteration and misbranding of drugs and food products. Required all drug applications to be filed with the FDA.

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Durham-Humphrey Act of 1951

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Amendment of FDCA requiring all products to have adequate directions unless they contain Caution label. Separated drugs into legend (prescription) and non-legend (over the counter).

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Kefauver-Harris Amendment of 1962

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Requires all medication in the U.S. to be pure, safe, and effective.

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Comprehensive Drug Abuse Prevention and Control Act of 1970

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Created the DEA, under Department of Justice supervision. Defined 5 Schedules for drugs based on potential for abuse.

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Schedule I

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No accepted medical use in U.S. and extreme potential for abuse.

Examples: Cocaine, Marijuana, Opium, Rohypnol

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Schedule II

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Medical use with high abuse potential with severe psychological or physical dependency. Examples: Adderall, Codeine, Morphine sulfate, OxyContin, Ritalin

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Schedule III

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Medical use with abuse potential.

Examples: Testosterone, Hydrodone + Acetaminophen

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Schedule IV

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Less abuse potential which may lead to limited physical or psychological dependence.

Examples: Ambien, Lorazepam

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Schedule V

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Less abuse potential. Includes exempt narcotics.

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DEA Form 224

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New Pharmacy Registration Form

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DEA Form 41

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Surrender of Controlled Substance to DEA or other Law Enforcement for Disposal

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DEA Form 222

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Transfer of Controlled Substance to another registrant. Records must be kept 2 years

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DEA Form 106

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Report Theft of Significant Loss of Controlled Substance. Must notify within 1 business day of discovery.

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Controlled Substances Records must be kept:

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at least 2 years

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All CII records and inventories must be

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kept separate from all other records

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Paper prescription records for Controlled Substances III, IV and V can be filed together if they have a

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Red "C" stamp not less than one inch high.

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Controlled Substance inventory must be done every 2 years. There must be an actual physical count of ________ drugs.

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CII

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DEA Form 222a

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used for ordering additional forms to order Controlled Substances

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Narcotic Addiction Treatment Act 1974

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AddictionTreatment Programs that use CS agents in treatment must register with DEA

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Drug Addiction Treatment Act 2000 (DATA)

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Allows individual physicians to treat drug dependence without having to register as a Narcotics Treatment Program.

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Combat Methamphetimine Epidemic Act (CMEA)

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limits sale of Ephedrine, phenylpropanolamine (PPA), and pseudoephedrine (PSE) to

3.6gm/day or 9 gm/month.

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Stark I and Stark II

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"anti-kickback" legislation which prohibits physicians with a financial interest from making referrals of Medicare/Medicaid patients to each other.

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MAC

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established Maximum Allowable Costs for drugs

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MTM

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Medication Therapy Management

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DUR

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Drug Utilization Review

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Medicare Part B

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covers Outpatient services, including DME

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Medicare Part D

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Covers Rx drugs and medical supplies for insulin administration

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Medicare part C

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Combinationof A&B in a managed care plan

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Medicare Part A

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covers Inpatient services