Pharmacy Technician Certification
(PTCB) Review - Federal Pharmacy Law
1906 - Federal Food and Drug Act Correct Answer-This act prohibits the sale of adulterated or
mislabeled food, drinksand drugs
1914 - Harrison Na
...
Pharmacy Technician Certification
(PTCB) Review - Federal Pharmacy Law
1906 - Federal Food and Drug Act Correct Answer-This act prohibits the sale of adulterated or
mislabeled food, drinksand drugs
1914 - Harrison Narcotic Act Correct Answer-This act limits the transport of opium. In order to purchase
opium, a prescription is required.
1938 - Food Drug and Cosmetic Act Correct Answer-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
1951 - Durham Humphrey Amendment Correct Answer-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
1962 - Kefauver-Harris Amendment Correct Answer-All drugs made from 1938 forward must be proven
save and effective. Also the FTC now handles drug advertisement. Stricter requirements for drugapproval. Manufacturersmust now register annually, be inspected ever 2 years, and report adverse
effects of drugs.
1970 - Comprehensive Drug Abuse Prevention and Control Act (Controlled substance Act - CSA) Correct
Answer-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.
1970 - Poison Prevention packaging act Correct Answer-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.
1983 - Orphan Drug Act Correct Answer-This act enables the FDA to promote the research and
marketing of drugs needed for the treatment of rare diseases.
1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment) Correct
Answer-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.
1988 - Food and Drug Administration Act Correct Answer-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 FDA1988 - Prescription Drug Marketing Act Correct Answer-This act banned the sale, trade, or purchase of
drug samples
1990 - Omnibus Budget Reconciliation Act (OBRA) Correct Answer-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.
1996 - Health Insurance Portability and Accountability Act (HIPAA) Correct Answer-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.
2006 - Combat Methamphetamine Epidemic Act (CMEA) Correct Answer-This act limits the purchase of
pseudophedrine(pse) products to 3.6g of pse per dat or 9g per 30 days
Class I Recall Correct Answer-An attempt must be made to notify the patient that the drug he/she may
be taking could cause serious harm or death
Class II recall Correct Answer-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 potencyClass III recall Correct Answer-Not likely to cause any serious adverse effects and does not go to the
customer level
OTC labeling must contain: Correct Answer-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)
Food, Drug, and cosmetic act requires precription drugs to contain: Correct AnswerName/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.
Package inserts must contain: Correct Answer-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
Package inserts must be distributed with the following drug classes: Correct Answer-Oral contraceptives,
estrogen-containing and progestational drugs, intrauterine contraceptive devices, diethylstilbestrol
products, accutane, metered-dose inhalersNational Drug Code (NDC) Correct Answer-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.
NDC first set (five numbers) indicate what? Correct Answer-Manufacturer
NDC second set/middle set (four numbers) indicates what? Correct Answer-Specific drug - each drug has
its own number
NDC last two numbers indicate what? Correct Answer-Package size - (100 tablets may be 01, 500 tablets
may be 05)
Schedule I drugs Correct Answer-These drugs have NO accepted medical use in the united states. These
drugs have the highest abuse potential
Schedule II drugs Correct Answer-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
Schedule III drugs Correct Answer-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
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