Term
| What was the Federal Food and Drug Act of 1906 concerned with? |
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Definition
| purity; it prohibited adulterated or misbranded food or drugs from interstate commerce. |
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Term
| What were the 1st attemps to control a specific class of drugs (ie narcotics)? |
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Definition
| International Opium Convention of 1912 and Harrison Narcotic Act of 1914 |
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Term
| What act created the FDA? |
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Definition
| Food, Drug and Cosmetic Act of 1938 |
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Term
| What created the legend drug? |
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Definition
| Durham-Humphrey Amendment of 1951 |
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Term
| What amendment created drug efficacy? |
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Definition
Kefauver-Harris amendment:
1. proof of effectiveness
2. proof of safety
3. good manufacturing practices
4. drug advertising
5. investigational drug procedures |
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Term
| What controlled use of depressants, stimulants, and hallucinogens? |
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Definition
| Drug Abuse Control Amendments of 1965. |
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Term
| What act consolidated the enforcement activites of the government and what did it form? |
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Definition
| Comprehensive Drug Abuse Prevention and COntrol Act of 1970; formed the DEA in 1973 |
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Term
| What amendment required that medical devices to have a pre-market approval by the FDA? |
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Definition
| Medical Device Amendment of 1976 |
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Term
| What Act helped with the developmental costs for rare diseases? |
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Definition
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Term
| What abbreviated the NDA for generics? |
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Definition
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Term
| What act dealt with samples? |
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Definition
| The prescription Drug Marketing Act of 1987. |
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Term
| What placed anabolic steroids in Schedule III? |
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Definition
| Anabolic Steroids Control Act of 1990 |
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Term
| What did the Omnibus Budget Reconciliation Act of 1990 do? |
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Definition
| It required that pts (at this time Medicaid pts) receiving a rx get a drug use review, counseling, and patient medication records. |
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Term
| What defined dietary supp as a special class of foods? |
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Definition
| Dietary Supplement Health and Edu Act of 1994. |
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Term
| What amendment followed the Thalidomide disaster and focused on drug efficacy? |
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Definition
| Kefauver-Harris Amendment of 1962 |
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Term
| What did the Food and Drug Modernization Act of 1997 encompass? |
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Definition
| Pediatric studies of drugs; pharmacy compounding, PET compounding, Expediting Study and Approval of Fast Track Drugs, Info program on clinical trials for serious or life-threatening diseases; RX only vs Federal Legend |
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Term
| What class is for products that will cause serious or fatal consequences? |
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Definition
| Class I (Class II- may cause serious but reversible health effects and ClassIII - not likely to cause adverse health consequences) |
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Term
| Patient Package insert: a pateint labeling or a pt info brochure is required to be dispensed with the following drugs? |
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Definition
1st required PPI: isoproterenol
Also: Oral contraceptives, Oral postcoital contraceptives (Diethylstilbestrol), injectable contraceptives (Medroxyprogesterone acetate), estrongens and progestational drug products |
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Term
| What are the procedures for a New Drug Application? |
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Definition
1. IND application filed with FDA
2. FDA action on IND
3. Informed Consent
4. Clinical Trials
5. NDA (sent after Phase 3-- the big phase) |
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Term
| What are the 3 segments of the NDC? |
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Definition
| Labeler code, drug product code, and package |
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Term
| Who is responsible for implementation of the Poison Prevention Packaging Act (PPPA)? |
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Definition
| The US Consumer Product Safety Commision (CPSC)-- same people who do the carseats |
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Term
| What is a pharmaceutical alternative? |
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Definition
| It refers to drug products that contain the same therapeutic moiety BUT may consist of different salts, esters or complexes, dosage forms, strengths (Most states do not allow substitution btwn pharmaceutical alternatives) |
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Term
| What is HIPAA also know as? |
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Definition
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Term
| What established the 5 schedules of controlled substances? |
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Definition
| Controlled substance Act of 1970 |
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Term
| Who has the authority to decide in which schedule a drug is placed? |
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Definition
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Term
| A pharmacist may manufacture w/out registering as a manufacturer an aquesous or oleaginous solution or solid dosage form containing narcotic-containing substance not exceeding what? |
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Definition
| 20% of the complete solution of mixture |
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Term
| If the total amount of "manufactured" sales to practitioners exceeds ______ of the total dosage units distributed during any 12mth period, the pharmacy must reg as a distributer as well. |
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Definition
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Term
| What application is filled out for a new application for controlled substances for a retail pharmacy...? |
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Definition
| DEA form 224 (the renewal application is called 224a) |
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Term
| What is the registration period and fees for a retail pharmacy for controlled substances (federal)? |
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Definition
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Term
| What form must be filled out to obtain controlled substances? |
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Definition
| DEA form 222 (order blooklets by the DEA (form 222d)). This form is a triplicate |
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Term
| What form do you fill out to report theft or loss? |
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Definition
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Term
| What filing method is allowed in Tx? |
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Definition
| 3 files (CII, CIII-V, and others) |
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