Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law

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  1. 1906 - Federal Food and Drug Act
    This act prohibits the sale of adulterated or mislabeled food, drinksand drugs
  2. 1914 - Harrison Narcotic Act
    This act limits the transport of opium. In order to purchase opium, a prescription is required.
  3. 1938 - Food Drug and Cosmetic Act
    This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal, This act requires drug companies to provide package inserts,requires that habit-forming drugs be labeled "may be habit forming" , requires that a new drug has to be proven safe under FDA guidelines before marketing
  4. 1951 - Durham Humphrey Amendment
    This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution:Federal law prohibits dispensing without a prescrition", requires physician supervision for the purchase of legend drugs. Also, over the counter drugs without medical supervision are required to have on the label: Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not
  5. 1962 - Kefauver-Harris Amendment
    All drugs made from 1938 forward must be proven save and effective. Also the FTC now handles drug advertisement. Stricter requirements for drug approval. Manufacturersmust now register annually, be inspected ever 2 years, and report adverse effects of drugs.
  6. 1970 - Comprehensive Drug Abuse Prevention and Control Act (Controlled substance Act - CSA)
    Drug enforcement agency (DEA) was formed.  Also controlled substanced were placed in schedules I-V based on abuse potential.Schedule I drugs have the highest abuse potential and schedule V drugs have the lowest abuse potential.
  7. 1970 - Poison Prevention packaging ac
    This act required childproof packaging on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations, such as dispensing nitroglycerin, or if a drug is packaged in such a small quantity it would not hard a child under 5 years old.
  8. 1983 - Orphan Drug Act
    This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.
  9. 1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment)
    This act streamlines the process for granting approval of generic drugs. It also give manufacturers incentives to develop new drugs by giving patent extensions. This act allows  generic drug companies the ability to rely on safety and efficacy  findings of an innovator's drug after the expiration of the patent.
  10. 1990 - Omnibus Budget Reconciliation Act (OBRA)
    This act requires a pharmacist to attempt or offer counsel to patients on all new prescriptions. Pharmacist must provide anem and description of drug, how much should be taken, side effects, contraindications, interactions, adverse effects, storage, refill information, and what to do if a dose is missed.
  11. 1996 - Health Insurance Portability and Accountability Act (HIPAA)
    This act created rules regarding the privacy/security of patient health information. This act provides limitations on who can access, distribute, and receive patient information. This act also makes health insurance portable for people switching jobs. This act also includes provisions that make health care information processing more cost effective by requiring standardized electronic submissions of claim information.
  12. 2006 - Combat Methamphetamine Epidemic Act (CMEA)
    This act limits the purchase of pseudophedrine(pse) products to 3.6g of pse per dat or 9g per 30 days
  13. Food, Drug, and cosmetic act requires precription drugs to contain:
    Name/address/phone# of dispensing pharmacy, patient and doctor's name, prescription number and the date filled, drug name/strength/quantity/directions for use, name/initials of dispensing pharmacist or technician, patient address, expiration date, refill information, precautions, the statement "federal law prohibits dispensing with
  14. Orange Book(approved drug products w/therapeutic equivalence evaluations)
    Compares therapeutic equivalence using an alphabetic rating system. A rated products can be substituted and B rated products cannot because they are not bioequivalent. This is published yearly
  15. US Pharmacopoeia general chapter 797:
    States the procedures and requirements for pharmaceutical compounding of sterile preparations
  16. Handbook on injectable drugs
    Lists injectable drug information such as compatability, storage and dosages
  17. OTC labeling must contain:
    Product Name, manufacturer address, net contents, all ingredients(active or inactive), habit-forming drugs contained within, caution/warning labels, directions for use(drug's purpose, dosage, frequency of administration in accordance to meals, symptoms, etc, route of administration)
  18. Package inserts must contain:
    Description of the drug, Clinical pharmacology, indications and usage, contraindications/precautions/warnings/adverse reactions, drug abuse/dependance/overdosage information, dosage/administration information, the date of the most recent label revision
  19. Package inserts must be distributed with the following drug classes:
    Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contraceptive devices, diethylstilbestrol products, accutane, metered-dose inhalers
  20. DEA 225
    needed to manufacture or distribute controlled substances
  21. DEA 363
    needed to operate a controlled substance treatment program or compound controlled substances
  22. DEA 224
    needed for a pharmacy to dispense controlled substances
  23. DEA 41
    Used to document the destruction of controlled substances
  24. DEA 106
    Used to report lost or stolen controlled substances. (required when 5% of yearly product sold is missing - ie 50 tablets from a 1000 yearly supply)
  25. DEA 222
    Used for purchsing and returning of outdated CII drugs (blue copy:purchaser keeps for 2 years, green copy:seller sends to local DEA, brown copy:seller keeps on file)
  26. USP/NF US pharmacopoeia/National Formulary
    Contains monographs and chemical characteristics of drugs
  27. USPDI US pharmacopoeia dispensing information
    Volume I:Drug info for healthcare provider Volume II: Drug info for patients Volume III: Therapeutic equivalency information and pharmacy law
  28. Physician's Desk Reference(PDR)
    Contains packet insert drug information intended for physicians and is published annually. Contains color pictures with a list of drug manufacturers including addresses and phone numbers
  29. Mosby's Complete Drug Reference
    Lists generic drugs in alphabetical order. Contains additional drug information
  30. American Drug Index
    rugs are listed alphabetically and provide brand,generic and the chemical names of the drugs. Gives alist of manufacturers, strengths and dosage forms of the drugs listed.
  31. When ordering a CIII medication what document is required for proof of receipt?
    Commercial invoice
  32. To whom are drug recalls, drug reactions, and outcomes reported?
  33. A list of drug package inserts could be located in which book?
    Physicians desk reference
  34. CDER
    Center for Drug evaluation and Research
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Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law
2013-11-02 20:47:52

Federal Pharmacy Law
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