Untitled Document
Untitled Document
Untitled Document
Federal Food and Drug Act of 1906 - ANS • Known as the Pure Food and Drug Act.
• Provided authority for federal inspection of meat products and prohibited the sale of
adulterated foods.
• Required that "Secret Elixirs" containing ingredients like: Cocaine, Heroin, Morphine and
Alcohol which were available at most stores as miracle cure-alls be labeled with correct
information about their ingredients as well as suggested dosages.
Narcotic Tax Act of 1914 - ANS • Known as the Harrison Narcotic Act.
• Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps.
• Required that any entity which produced, distributed, dispensed or sold opiates be registered
with the IRS.
• Emphasis was on attempting to control the massive flow of opiates in order to protect the
public from rising addiction.
Federal Food, Drug and Cosmetic Act of 1938 - ANS • Known as FDCA 1938.
• Replaced the Food and Drug act of 1906.
• Provided better clarification about misbranding definitions.
• Provided better clarification about adulteration definitions.
• Gave the FDA authority to require adequate testing of new drugs for safety.
The Durham-Humphrey Amendment of 1951 - ANS • Created a distinction between "OTC" and
"Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
The Kefauver-Harris Amendment of 1962 - ANS • Also known as the "Drug Efficacy
Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs
before approval .
• Required drug advertising to be more closely regulated and disclose accurate information
about side effects
The Bureau of Narcotics and Dangerous Drugs (BNDD) - ANS • Predecessor agency of the
DEA.
• In 1973 the BNDD merged into the DEA.
• DEA (Drug Enforcement Administration)
Drug Abuse Prevention / Control Act of 1970 - ANS • Also known as the Controlled
Substances Act (CSA)
• Completely replaced the Harrison Act.
• Required the use of DEA Numbers
• Required comprehensive record keeping and transaction tracking.
• Enforced by the DEA under the US Dept. of Justice
Poison Prevention Packaging Act of 1970 - ANS • Also known as the PPPA
• Designed to reduce the risk of children ingesting dangerous substances.
• Required locking caps on most prescriptions
Combat Methamphetamine Epidemic Act (2005) - ANS • Enacted to regulate the OTC sales of
pseudoephedrine.
• Identity and address of each purchaser to be kept for two years.
• Daily sales of regulated products not to exceed 3.6 grams.
• 30 day purchase limit not to exceed 9 grams
• 30 day purchase via mail order not to exceed 7.5 grams
DISPENSING OF CIII CIV and CV, DRUGS - ANS * Cannot be refilled more than five times
within 6 months
* Cannot be filled for the prescription older than six months.
* Do not require any DEA 222 form to fill the order.
*can only be transferred once
*Drugs can be mailed if content not marked
This is an autoimmune disease in which the thyroid is overactive, and produces excessive
amounts of thyroid hormones: - ANS Graves
If two drugs are taken together and one of them intensifies the action of the other, what type of
drug interaction has occurred? - ANS Potentiation
Which of these herbal medications can be used to treat anxiety? - ANS kava
This law defined two specific categories for medications: prescription and over-the-counter. -
ANS Durhan-Humphrey amendment
A drug is recalled by the FDA, but the problem is unlikely to cause any adverse health reactions.
What type of recall would this be? - ANS Class III
a drug is recalled because it causes temporary adverse health consequences - ANS Class II
According to federal law, DEA forms need to be maintained for ____ years. - ANS 2
This federal law requires pharmacists to review Medicaid recipients' entire drug profile before
filling their prescriptions. - ANS Omnibus Budget Reconciliation Act of 1990
Type of health plan that requires all of your health care services to go through a primary care
doctor, who can refer you to specialists in a network - ANS HMO
health maintenance organization
Which part of medicare covers durable medical equipment? - ANS medicare part B