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Durham-Humphrey Amendment of 1951
• 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:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical
supervision.
Kefauver-Harris Amendment of 1962
• 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
Harrison Narcotic Act
a 1914 congressional act that criminalized the sale and use of narcotics
,Comprehensive Drug Abuse Prevention and Control Act of 1970
established schedules of controlled substances and moved enforcement to
the Justice Department (C-1 to C-5)
Established the DEA
DEA
Enforces the controlled substance act under the DOJ. Makes sure all
controlled substances are manufactured, distributed, and stored properly.
Control 1 (C-1) drugs
High abuse. Considered not medical use or street drugs. (Marijuana,
ecstasy, heroin, LSD)
Control 2 (C-II) drugs
Consists of narcotics, pain killers, ADHD drugs. Highly addicting
(Percocet, Endocet, Norco, Fentanyl, Morphine)
Control 3 (C-III) drugs
Mild pain killers, anabolic steroids and caffeine pills, can be moderately
abused (Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine;
Ketamine)
,Control 4 (C-IV) drugs
Anti-anxiety, anti-depressants, anti-psychotics, sleep aids, appetite
suppressants, Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax,
Carisoprodol/soma, clonazepam/klonopin, lorazepam/Ativan,
temazepam/restoril)
Control 5 (C-V) Drugs
Low Codeine amounts in cough suppressants. Considered the least abusive
(phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory
exact count for schedule II and an estimated count for III-V drugs must be
performed every 2 years
C-II Supply
Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy?
Yes, and there are exceptions: for patients in community care or in long
term IV care
Expiration date for C-II?
No expiration date but just be filled in 1 month or in a 10 day period
, Can doctor make a phone prescription for C-II?
Only for extreme emergencies. A hard copy must be sent to the
pharmacy in 7 days or pharmacy can report the doctor to DEA
DEA Form 222
must be used whenever Sch II drugs are bought, sold or transferred
between pharmacies or qualified distributors, can only order 10
medications at a time
Form 222 triplicate forms?
1) Seller
2) DEA
3) Pharmacy
How long must form 222 be kept in file?
For 2 years
Can you make mistakes on form 222?
No, must be mistake free. If a mistake is made, it is kept on file
Can you loan Form 222 to other pharmacies?
No, each form is different for each pharmacy. Can loan medication to other
pharmacies when ordering.