Substances Act Study Guide Exam And
100% Accurate Answers.
1970 - Answer Controlled Substances Act; gave FDA authority to determine the scheduling of
controlled substances
1973 - Answer Creation of the DEA by the Department of Justice; removed scheduling responsibility
from the FDA
Two Key Points of Federal Controlled Substance Laws - Answer (1) Scheduling
(2) Registration
Exceptions to returning controlled substances to a pharmacy - Answer 1. Dispensing error
2. Recall of the drug OR
3. Registered as an authorized collector
Who is permitted to be an authorized collector? - Answer (1) Manufacturers
(2) Distributors
(3) Reverse Distributors
(4) Narcotic treatment programs
(5) Hospitals/ Clinics with an on-site pharmacy
,(6) Retail pharmacies AND
(7) Law enforcement agencies can take back controls (no DEA registration is required)
Who cannot be an authorized collector of controlled substances? - Answer (1) Physicians/ other
practitioners
(2) Hospitals/ other clinics without a pharmacy
Who must register with federal DEA? (What are the classifications?) - Answer (1) Manufacturer
(2) Distributor
(3) Dispenser
(4) Research; other than narcotic treatment program
(5) Instructional activities
(6) Narcotic treatment programs
(7) Research with C1 substances
(8) Chemical analysis
(9) Importer
(10) Exporter (C1 - C4 substances)
,(11) Compounding by mixing, preparing, packaging, or changing dosage form of C2 - C5 narcotic for a use
in maintenance or detoxification by another narcotic treatment program (detox compounder)
Five most important categories for federal DEA registration - Answer (1) Manufacturer
(2) Distributor
(3) Dispenser
(4) Narcotic treatment program
(5) Detox compounder
Categories of application for controlled substance registration - Answer II narcotic
II non-narcotic
III narcotic
III non-narcotic
IV
V
Definition of a narcotic - Answer (1) Opium, opiates, derivatives of opium and opiates, including their
isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such
isomers, esters, ethers and salts is possible within the specific chemical designation. Such term does not
include the isoquinoline alkaloids of opium.
(2) Poppy straw and concentrate of poppy straw.
(3) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine and
derivatives of ecgonine or their salts have been removed.
, (4) Cocaine, its salts, optical and geometric isomers, and salts of isomers.
(5) Ecgonine, its derivatives, their salts, isomers and salts of isomers.
(6) Any compound, mixture, or preparation which contains any quantity of any of the substances
referred to in paragraphs (1) through (5) of this definition.
Applicant for a Controlled Substance Registration - Answer The applicant must be an owner, active
partner, or any corporate officer. May assign, by power of attorney, another person to sign orders for
purchases of controlled drugs.
When an entity applies for the registration, the registration form is signed by the "owner". The "owner"
is: - Answer (1) The "sole proprietor" if the entity is a sole proprietorship (i.e., "Joe's Pharmacy" - Joe
completes the form).
(2) Partnership - Any partner is the owner, and can complete the form (i.e., "Joe and Flo's Pharmacy" -
either Joe or Flo can complete the form.)
(3) Corporation - Any Officer or Director of the corporation can complete the form.
(4) The person who completes the form is referred to as the "registrant". The entity that receives the
registration is also called the "registrant".
The Power of Attorney must be EXECUTED by... - Answer The person who signed the most recent
application for DEA registration or reregistration; the person to whom the power of attorney is being
granted; and two witnesses.
The Power of Attorney must be REVOKED by... - Answer the person who signed the most recent
application for DEA registration or reregistration, and two witnesses.
What is a power of attorney? - Answer A document that is signed by the "registrant" to give the
authority and responsibility over controlled substances to one or more individuals