STUDY GUIDE 2026/2027 COMPLETE
QUESTIONS WITH VERIFIED CORRECT
ANSWERS || 100% GUARANTEED PASS
<NEWEST VERSION>
FDA (food and drug administration) - ANSWER✔-approve new drugs to be sold
in the US
-process New Drug Applications (NDA)
-regulate package inserts
-regulate drug advertising
-issue recalls
-federal agency
DEA (Drug Enforcement Agency) - ANSWER✔-federal agency
-enforce the CSA ( controlled substances act)
-track controlled substances manufactured and sold
-investigates all violations involving controlled substances
-set the DEA Sch. Definitions
-issue DEA numbers
BOP (Board of Pharmacy) (each state) - ANSWER✔-regulate licensing of
pharmacists
-regulate licensing of pharmacy technicians
,-set state laws/ requirements
-outline the operating guidelines in the pharmacy
-investigate violations of the operating guidelines
-determine state regulated controlled substances
-state agency
Joint Commission on Accreditation of Healthcare Organizations - ANSWER✔-
watches over healthcare organizations
-third party auditors/ regulators for insurance providers
DEA Schedule I - ANSWER✔-no accepted medical use
-extremely high potential for abuse
-high potential for psychological and physical dependency
-ex. weed, heroin, mdma
Pure Food and Drug Act (1906) - ANSWER✔Forbade the manufacture, sale, and
transportation of adulterated or mislabeled foods and drugs.
Shirley Amendment of 1912 - ANSWER✔Prevented fraudulent therapeutic
claims by drug manufacturers
Harrison Act of 1914 - ANSWER✔Established the word narcotic and required the
use of a stamp on narcotic drug containers. Also regulated the importation,
manufacture, sale, and use of opium, codeine, and their derivatives
Food, Drug, and Cosmetic Act of 1938 - ANSWER✔A New drug could not be
marketed until proven safe, tested for toxicity, and required adverse drug effects to
be reported.
,Durham-Humphrey Amendment (1951) - ANSWER✔Replaced Laws of 1938.
Required designation of whether or not the drug was prescription or OTC
Schedule I - ANSWER✔This type of drug has no accepted medical use in the
United States and has a high potential for abuse
Schedule II drugs - ANSWER✔Accepted for medical use but with severe
restrictions (high potential for abuse)
Schedule III drugs - ANSWER✔Have low potential for abuse with an accepted
medical use. Perscription only
Schedule IV - ANSWER✔Abuse potential exists, but less than Sch III. Examples
are: Ambien, Darvocet and Lorazepam.
Schedule V drugs - ANSWER✔Lowest potential for abuse. May be sold OTC to
people that show ID
Kefauver-Harris Amendment (1962) - ANSWER✔Requires proof of safety and
efficacy of a drug for approval before marketing
Controlled Substances Act (1970) - ANSWER✔Replaced all laws passed prior to
it concerning drug control. 5 drug schedules put in place based on potential for
abuse.
Poison Prevention Packaging Act (1970) - ANSWER✔Implemented child
resistant packaging
, Drug Listing Act of 1972 - ANSWER✔drugs must have a National Drug Code
number.
Drug Regulation and Reform Act of 1978 - ANSWER✔Quicker development and
distribution of new drugs
Orphan Drug Act of 1983 - ANSWER✔Established funding for research of rare
chronic illnesses for new and old drugs.
Drug Price Competition and Patent Term Restoration Act of 1984 -
ANSWER✔Eased requirements for marketing generic drugs
Omnibus Budget Reconciliation Act (OBRA 1990) - ANSWER✔Mandated that
OTC drugs be documented
Anabolic Steroid Control Act of 1990 - ANSWER✔placed all into category III
drugs (CSA)
Prescription Drug Amendments of 1992 - ANSWER✔Allowed rapid approval of
drugs for life-threatening diseases
Food and Drug Administration Modernization Act of 1997 - ANSWER✔Allowed
rapid approval of drugs by the FDA
Pharmacokinesis - ANSWER✔the movement of drugs through the body via
absorbtion, distribution, metabolism, and excretion