Federal Pharmacy Law Review

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1.

1906 - Federal Food and Drug Act 1914 - Harrison Narcotic Act 1938 - Food Drug and Cosmetic Act

This act prohibits the sale of adulterated or mislabeled food, drinksand drugs This act limits the transport of opium. In order to purchase opium, a prescription is required. 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 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 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. 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.

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2.

1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment)

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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. This act established the FDA as an agency of the Department of Health and Human Services. Any adverse drug reactions and outcomes should be reported to the FDA This act banned the sale, trade, or purchase of drug samples 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. 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. This act limits the purchase of pseudophedrine(pse) products to 3.6g of pse per dat or 9g per 30 days DEA Number

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1988 - Food and Drug Administration Act 1988 Prescription Drug Marketing Act 1990 - Omnibus Budget Reconciliation Act (OBRA)

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4.

1951 - Durham Humphrey Amendment

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13.

5.

1962 KefauverHarris Amendment

1996 - Health Insurance Portability and Accountability Act (HIPAA)

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1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled substance Act CSA) 1970 - Poison Prevention packaging act

14.

2006 - Combat Methamphetamine Epidemic Act (CMEA) A doctor that precribes medications must have this? A list of drug package inserts could be located in which book?

7.

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. This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.

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16.

Physicians desk reference

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1983 - Orphan Drug Act

17.

A prescription for alprazolam may be refilled how many times? alprazolam American Drug Index

5 times

36. 37.

Codeine Codeine w/ acetaminophen (tylenol No. 3) Controlled substance inventory must be done how often? Cough syrups containing hydrocodone DEA 41 DEA 106

Schedule II Codeine Schedule III

18. 19.

Schedule IV Xanax Drugs 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. Schedule II Adderal Schedule III Schedule V Lomotil Schedule V Robitussin AC Schedule II Percocet Schedule III Empirin # 3 Schedule II Percodan The most stringent law
43. 42. 38.

Every two years

39.

Schedule III Tussionex

20. 21.

Amphetamines Anabolic steroids(testosterone) Antidiarrhealsw/opioid Antitussives w/codeine APAP + ocycodone ASA + codeine ASA + oxycodone Because federal and state record keeping requirements can vary in each state, which law should be followed? Benzodiazepines(diazepam, alprazolam, lorazepam) carisoprodol + codeine Class I Recall

40.

Used to document the destruction of controlled substances 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) 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) needed for a pharmacy to dispense controlled substances needed to manufacture or distribute controlled substances needed to operate a controlled substance treatment program or compound controlled substances Schedule II Dexedrine Schedule IV Valium Schedule IV Durad, Tepanil, Tenuate Schedule III Contains a comprehensive listing of drugs and comparative drugs. These drugs are organized by therapeutic class and provide general information with a list of monographs. Also contains listing of drug manufacturers, addresses and phone numbers. Updated monthly Gives a listing of drugs by pricing, strengths, sizes, manufacturers, brands, and generics Schedule II Duragesic Schedule II Duragesic Schedule IV Dalmane

41.

22. 23. 24. 25. 26. 27.

DEA 222

DEA 224 DEA 225 DEA 363

44.

28.

Schedule IV Schedule III Soma with codeine An attempt must be made to notify the patient that the drug he/she may be taking could cause serious harm or death The probability of serious harm is not likely and the effects may be temporary or reversable. This recall does not go to the customer level and is usually due to problems with consistency of potency Not likely to cause any serious adverse effects and does not go to the customer level Schedule IV Klonopin Schedule IV Tranxene Schedule II

45.

29.

46. 47. 48. 49.

dextroamphetmine diazepam Diethylpropion Drobabinol (Marinol) Drug facts and comparisons

30.

31.

Class II recall

50.

32.

Class III recall

51.

Drug Topics Red Book Fentanyl fentanyl flurazepam

52. 53. 54.

33. 34. 35.

clonazepam clorazepate Cocaine

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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 without a prescription", package insert on selected drugs. The most stringent law

74.

Mosby's Complete Drug Reference National Drug Code (NDC)

Lists generic drugs in alphabetical order. Contains additional drug information Each drug produced by a manufacturer is identified with a specific NDC number. THe NDC number is composed of three sets of numbers, which identifies the manufacturer, drug, and pack size. Manufacturer

75.

76.

56.

For general laws concerning pharmacy rules and regulations, which law should be followed? Handbook of injectable drugs

NDC first set (five numbers) indicate what? NDC last two numbers indicate what? NDC second set/middle set (four numbers) indicates what? Opium Orange Book(approved drug products w/therapeutic equivalence evaluations) OTC labeling must contain:

77.

Package size - (100 tablets may be 01, 500 tablets may be 05) Specific drug - each drug has its own number

78.

57.

Used to determine the compatibility of medications that will be used in an IV bag. Shows the compatability, solubility, and stability of medications Lists injectable drug information such as compatability, storage and dosages Schedule I Schedule III Hycotuss Schedule III

79. 80.

Schedule II 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. 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) Schedule II Oxycontin Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contraceptive devices, diethylstilbestrol products, accutane, metered-dose inhalers

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Handbook on injectable drugs Heroin hydrocodone + guaifensin Hydrocodone w/ acetaminophen (vicodin, lorcet, lortab, norco) Hydromorphone hyrdocodone ibuprofen + hyrocodone lorazepam LSD Marijuana Material Safety Data Sheets

59. 60.

81.

61.

62. 63. 64.

Schedule II Dilaudid Shceulde III Hycodan Schedule III Vicoprofen Schedule IV Ativan Schedule I Schedule I MSDS provides information on hazardous materials that may be in the pharmacy and also provides information on disposal, storage, safe use and clean up of these medications Schedule II Demerol Schedule I Schedule II Dolophine Schedule II Ritalin Schedule II MS Contin
88. 85. 86. 87. 84. 82. 83.

Oxycodone Package inserts must be distributed with the following drug classes: Package inserts must contain:

65. 66. 67. 68.

69. 70. 71. 72. 73.

Meperidine Mescaline Methadone Methylphenidate Morphine

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 Schedule IV Talwin Schedule IV Talwin Schedule IV Talwin NX Schedule I

Pentazocine pentazocine pentazocine naloxone Peyote

89. 90. 91.

Phenobarbitol Phentermine Physician's Desk Reference(PDR)

Schedule IV Solfoton Schedule IV Fastin 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 Schedule IV Darvocet N These drugs have NO accepted medical use in the united states. These drugs have the highest abuse potential These drugs may NOT be refilled. The ordering of these drugs requires a DEA 222 form. The returning of out-of-date schedule II drugs requires a DEA 222 form. These drugs have a high abuse potential that may lead to sever physical or psychological dependence These drugs may be refilled 5 times in a six month period. These drugs have less potential for abuse/dependence than schedule I or schedule II drugs These drugs may be refilled 5 times in a 6 month period. These drugs have less potential for abuse/dependence than schedule II/III drugs. These drugs have less potential for abuse than schedule II, III, and IV drugs. Schedule II Seconal Schedule IV Restoril The last day of august

105.

Two file prescription filing system #2:

One file for CDS-CII only. Another file for CDS CIII-CV and all other drugs (CDS-CIII must be marked with a one inch high red "C" on the bottom right corner) States the procedures and requirements for pharmaceutical compounding of sterile preparations Contains monographs and chemical characteristics of drugs Volume I:Drug info for healthcare providerVolume II: Drug info for patientsVolume III: Therapeutic equivalency information and pharmacy law 2 letters followed by 7 numbers. First letter is an A or B. Second letter is first letter of last name. The last number of the sum of odd numbers + (sum of even number) * 2 should equal the last number Manufacturer, drug, package size

106.

US Pharmacopoeia general chapter 797:

92.

proxyphene +APAP Schedule I drugs Schedule II drugs

93.

107.

USP/NF US pharmacopoeia/National Formulary USPDI US pharmacopoeia dispensing information

94.

108.

109.

Valid DEA Number

95.

Schedule III drugs

96.

Schedule IV drugs

110.

97.

Schedule V drugs Secobarbital TEMAZEPAM The expiration date on a bottle of Naproxen is 8/08. When will this drug expire? Three file prescription filing system: To whom are drug recalls, drug reactions, and outcomes reported? triazolam Two file Prescription filing system #1:

What do the first five, middle four, and last two digits of an NDC number represent? What is the maximum amount of refills for CIIICV prescriptions in a six,month period? When drug manufacturers notify a pharmacy of a drug recall , how are the affected drugs identified? When ordering a CIII medication what document is required for proof of receipt? Which drug recall must go to the customer level? Which form is used to report lost or stolen drugs? Which form is used when ordering CII drugs? Which schedule has no medicinal use?

111.

5 refills

98. 99. 100.

112.

Lot number and expiration date

113.

Commercial invoice

101.

One file for CDS-CII, one file for CDSCIII-CV and one file for all other prescriptions FDA
114.

102.

Class I DEA 106

115.

103. 104.

Schedule IV Halcion One file for CDS-CII and CDS-CIIICV(marked with a red "C" one inch high at thebottome right corner) and another file for all other prescriptions

116.

DEA 222 Schedule I

117.

118. 119.

Who may initiate the ordering of an investigational drug? Who may order controlled substance schedule CI drugs?

Physician No one