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Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law Questions And Answers 100% Correct 1. PTCB federal pharmacy law practice questions with answers 2. 100% correct PTCB federal law study guide 3. Pharmacy technician certification federal law exam prep 4. Best PTCB federal pharmacy law review materials 5. Free federal pharmacy law questions for PTCB exam 6. PTCB federal law study tips and tricks 7. Comprehensive federal pharmacy law review for PTCB 8. PTCB federal law exam pass rate strategies 9. Federal pharmacy regulations study guide for PTCB 10. PTCB federal law question bank with explanations 11. How to ace PTCB federal pharmacy law section 12. PTCB federal law mock exam with answers 13. Federal pharmacy law flashcards for PTCB certification 14. PTCB federal law exam common mistakes to avoid 15. Latest updates on federal pharmacy laws for PTCB exam 16. PTCB federal law review course online 17. Federal pharmacy law mnemonics for PTCB exam 18. PTCB federal law
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ANS This act prohibits the sale of adulterated or mislabeled food, drinksand drugs
ANS This act limits the transport of opium. In order to purchase opium, a prescription is required.
ANS 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 form- ing" , requires that a new drug has to be proven safe under FDA guidelines before marketing
ANS This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution ANSFederal 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 ANS Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not
ANS 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.
substance Act - CSA) ANS Drug enforcement agency (DEA) was formed. Also con- trolled substanced were placed in schedules I-V based on abuse potential.Sched- ule I drugs have the highest abuse potential and schedule V drugs have the lowest abuse potential.
ANS This act required childproof packag- ing 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.
ANS This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.
Amendment) ANS 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.
ANS 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
ANS This act banned the sale, trade, or purchase of drug samples
ANS This act requires a pharmacist to attempt or offer counsel to patients on all new prescriptions. Pharma- cist must provide anem and description of drug, how much should be taken, side effects, contraindications, interactions, adverse effects, storage,
- Name/address/phone# of dispensing pharmacy, patient and doctor's name, pre- scription number and the date filled, drug name/strength/quantity/directions for use, name/initials of dispensing pharmacist or technician, patient address, ex-
piration date, refill information, precautions, the statement "federal law prohibits dispensing without a prescription", package insert on selected drugs.
Description of the drug, Clinical pharma- cology, indications and usage, contraindications/precautions/warnings/adverse re- actions, drug abuse/dependance/overdosage information, dosage/administration information, the date of the most recent label revision
Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contra- ceptive devices, diethylstilbestrol products, accutane, metered-dose inhalers
ANS Each drug produced by a manufacturer is identi- fied with a specific NDC number. THe NDC number is composed of three sets of numbers, which identifies the manufacturer, drug, and pack size.
ANS Manufacturer
ANS Specific drug
ANS Package size - (100 tablets may be 01, 500 tablets may be 05)
ANS These drugs have NO accepted medical use in the united states. These drugs have the highest abuse potential
ANS Schedule I
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule II
ANS Schedule III
ANS Schedule III
ANS Schedule III
ANS Schedule III
ANS Schedule III
ANS Schedule IV
ANS Schedule IV
ANS Schedule IV
ANS Schedule IV
ANS Schedule IV
ANS Schedule V
ANS Schedule V
ANS Every two years
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)
ANS One file for CDS-CII, one file for CDS- CIII-CV and one file for all other prescriptions
ANS 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)
ANS 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)
ANS Used to document the destruction of controlled substances
ANS needed for a pharmacy to dispense controlled substances
ANS needed to operate a controlled substance treatment program or compound controlled substances
ANS needed to manufacture or distribute controlled substances
ANS DEA Number
ANS 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
ations) ANS 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.
ANS Contains monographs and chemical characteristics of drugs
ANS Volume I Drug info for healthcare provider Volume II Drug info for patients Volume III Therapeutic equiv- alency information and pharmacy law
States the procedures and re- quirements for pharmaceutical compounding of sterile preparations
ANS 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
ANS The most stringent law
should be followed? ANS The most stringent law
affected drugs identified? ANS Lot number and expiration date
represent? ANS Manufacturer, drug, package size
ANS Physicians desk reference
six-,month period? ANS 5 refills
ANS Physician
ANS No one
expire? ANS The last day of august
ANS Class I
ANS Schedule I
ANS 5 times
ANS ho