Controlled Substance: Distribution Flashcards
Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act)
Established a closed system for manufacturing, distributing, and dispensing of controlled substances enforced by the DEA
Three titles of the Controlled Substances Act
Title I: rehabilitation for drug abusers
Title II: registration and distribution of CS
Title III: importation and exports of CS
Do states have individual CS laws?
Yes
Responsibility of DEA under the Controlled Substances Act
- Prevent diversion and abuse of CS
2. Ensure adequate and uninterrupted supply to meet country’s legitimate medical, scientific, and research needs
What are the 2 separate classifications of Controlled Substances?
Narcotics and nonnarcotics
What is a narcotic
Any drug derived from opium
What 3 factors influence which controlled schedule drugs fall under
currently accepted medical use, abuse potential, and degree to which drug may cause physical or physiological dependence
What is a C-I drug?
drugs that have no accepted medical use and may not be prescribed, dispensed, or administered from medical use
Which CS schedule has the highest potential for abuse
C-I/C-II
What are C-II drugs?
drugs that currently have an accepted medial use in treatment in the U.S.
Are there any exceptions to C-II drugs?
yes, but they must have severe restrictions
The abuse of C-II drugs may lead to
severe physical or psychological dependence
what are examples of C-II drugs
morphine, amphetamine, methylphenidate, lisdexamfetamine, cocaine, fentanyl, oxycodone, hydrocodone, methadone, meperidine, hydromorphone
what are examples of C-I drugs
marijuana, LSD, peyote, mescaline, heroin, bath salts, THC, GHB, ecstasy
What are C-III drugs
have a potential for abuse less than C-I or C-II drugs and have a currently accepted medical use
examples of C-III drugs
anabolic steroids (oxandrolone, testosterone), dronabinol, ketamine, buprenorphine
are there any exceptions to C-III drugs
yes, tablet products that contain no more than 90 mg codeine per dosage unit
What are C-IV drugs
drugs that have a lower potential for abuse than C-III drugs and may lead to limited physical or psychological dependence
examples of C-IV drugs
phenobarbitol, benzodiazepines (alprazolam, diazepam, lorazepam), butorphanol, carisoprodol, tramadol, lorcaserin, modafinil, suvorexant, zaleplon, zolpidem, eszopiclone
What are C-V drugs
drugs that have a low potential for abuse relative to C-IV drugs and abuse may lead to physical or psychological dependence
examples of C-V drugs
codeine suspensions, diphenoxylate/atropine, pregablin, lacosamide, ezogabine
Who schedules controlled substances?
the attorney general, however they must request scientific and medical evaluation of the drug and have recommendation from secretary of DHHS
Do you have to be registered to handle controlled substances?
yes, every person who handles controlled substances must be registered with the DEA or be exempt from registration
Who does not have to register with the DEA to handle CS?
agents or employees of registrants, drug reps, common carriers, ultimate users, prescribers/dispensers in the service of the US government, and law enforcement officers
How do practitioner’s at hospitals register
they use the hospital’s dea registration number
what is the definition of dispensing CS?
to deliver a CS to an ultimate user pursuant to the lawful order of a practitioner
what does dispensing include
prescribing, administering, and dispensing
do community pharmacists have to register with the DEA
no, they are agents of an institutional practitioner and are exempt
What is the definition of manufacturing
the production, preparation, compounding, or processing of a drug as well as packaging, repackaging, labeling, or relabeling
What must manufacturers ensure when labeling CS
each bottle must contain identification symbol of the schedule
what is the definition of distributing
to deliver CS other than administering or dispensing
can practitioners return CS to the manufacturer or supplier?
yes and they don’t need to register as a distributor as long as appropriate records are maintained
