pharmacy technician certification ptcb review federal pharmacy law terms and explanations latest update 2022
1906 federal food and drug act
1914 harrison narcotic act
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Pharmacy Technician Certification (PTCB)
Review - Federal Pharmacy Law
1906 - Federal Food and Drug Act - This act prohibits the sale of adulterated or mislabeled
food, drinksand drugs
1914 - Harrison Narcotic Act - This act limits the transport of opium. In order to purchase
opium, a prescription is required.
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
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
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.
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.
1970 - Poison Prevention packaging act - 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 - 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) - 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 - 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
1988 - Prescription Drug Marketing Act - This act banned the sale, trade, or purchase of
drug samples
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.
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.
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
Class I Recall - 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 - 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
Class III recall - Not likely to cause any serious adverse effects and does not go to the
customer level
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)
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.
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