Exam 2 Flashcards
(16 cards)
1914 Harrison Narcotics Act
required importers, manufacturers, and distributors of cocaine and opiates to:
-register with the U.S. Treasury (the first enforcement agency of controls)
-pay a special tax on these drugs
-keep records of each transaction
1970 Comprehensive Drug Abuse Prevention and Control Act: Title II (commonly referred to as Controlled Substances Act)
established five separate schedules of controlled substances - regulated the manufacturing, distribution, and dispensation of CS
Sale of OTC controlled substances - limits
-any controlled substance containing opium: 240 mL or 48 dosage units
-any other controlled substance: 120 mL or 24 dosage units
in a 48-hr period
Sale of pseudoephedrine, ephedrine, and phenylpropanolamine - limit per day and per 30 daays
per day - 3.6 grams
per 30 days - 9 grams
DEA form 224
Application for dispensing or instructing registration
DEA form 225
Application for manufacturer, distributor, reverse distributor, researcher, lab, importer, exporter
How long is the dispensing/instructing registration valid for?
3 years
Narcotics definition
anything derived from opium or cocaine
The following registration types do not permit coincident activities:
- reverse distributing
- narcotic treatment program (including compounder)
- exporting
Dispensing/instructing registrants may perform the following coincident activities:
- may conduct research/instructional activities with substances for which registration was granted
- pharmacist may manufacture a product containing a narcotic (II-V) in a proportion not exceeding 20% of complete compound
- a retail pharmacy may perform central fill pharmacy activities
DEA number: “big four” prescriber letters
A, B, F, G
DEA number: mid-level practitioner letter
M
What does the second letter in the DEA number represent?
registrant’s last name or name of business that initially registered
What items cannot be stored centrally?
- completed 222 forms
- inventories
- prescriptions
CSA requires all records and reports involving controlled substances to be kept for at least how long after their origin date?
two years
Acceptable C-II Faxed Original Prescriptions
- C2 narcotic to be compounded and directly administered to patient by injection
- C2 narcotic for patient in hospice care
- Any C2 for patient in long term care facility