Which entity…
- Prohibits adulteration and misbranding of drugs
- Outlines New Drug Applications (NDA)
- Establishes labeling requirements
- Created the FDA and their powers
-Requires patient package inserts, med guides, and Risk Evaluation and Mitigation Strategies (REMS)
- Requires good manufacturing practices (GMP)
Established drug-pregnancy categories
FDCA
Federal law enforcement body responsible for enforcing the Controlled Substances Act
DEA
Controlled Substances Act
- Purpose: “To improve the administration and regulation of _____, _______, and _______ of controlled substances by providing a ‘closed’ system of legitimate handlers of these drugs”.
- Any entity that performs one of these acts, must be _________ with the DEA
- manufacturing, distribution, and dispensing
- registered
DEA Registrants
- Manufacturer
- Distributor
- Reverse Distributor
- Dispenser ($55100/3years)
- Individual/Institutional Practitioners, and Pharmacies
- Researcher Schedule I
- Researcher Schedule II – V
- Narcotic Treatment Programs
- Chemical Analysts
- Importers
- Exporters
DEA Registration
- Required for _____ general location
- Each pharmacy must have ___ ___ DEA registration
- ___ registration needed for hospital and pharmacy
- Hospital that owns a facility such as a clinic or ambulatory surgical center at a ______ physical location must obtain _______ DEA registration for those facilities
- each
- its own
- One
- different, separate
DEA Registration
- Must have all required _____ _____ first
For a pharmacy in Texas:
Pharmacy license
Controlled substance registration
- state licenses
- TSBP
- DPS
Registration application for:
- Retail pharmacies, hospitals, clinics, practitioners, mid-level practitioners, and teaching institutions
DEA 224 form
Registration application for:
- Manufacturers, distributors, researchers, analytical laboratories, importers, and exporters
DEA 225 form
Registration application for:
- Narcotic treatment facilities
DEA 363 form
Certificate of Registration
- Issued once the application is _______
- Certificate must be kept at the pharmacy and be readily ______ and ____________
- Does NOT have to be ______ ________ in the pharmacy
- approved
- retrievable and accessible
- publicly displayed
Schedule I
- ___________ drugs
- Accepted medical use?
- Abuse potential?
-Illicit
(Heroin, Marijuana, LSD, MDMA/ecstasy, dihydromorphine, mescaline, peyote)
- No
- High
Schedule II
- Drugs for _____, ____, ____ _____
- Accepted medical use?
- Abuse potential?
- Abuse can lead to ______ _______ or ____________ dependence
- pain, ADHD, oral barbiturates
- yes
- High
- severe physical or psychological
Schedule III
- examples
- Accepted medical use?
- Abuse potential?
- Abuse can lead to…
- pain COMBOS, suppository barbiturates
- yes
- abuse potential less than those in Sched I-II
- moderate/low physical or high psychological dependence
Schedule IV
- example
- Accepted medical use?
- Abuse potential?
- Abuse can lead to…
- benzodiazepines
- yes
- abuse potential less than those in Sched III
- limited physical or psychological dependence, relative to Sched III
Schedule V
- example
- Accepted medical use?
- Abuse potential?
- Abuse can lead to…
- cough syrups
- yes
- abuse potential less than those in Sched IV
- limited physical or psychological dependence, relative to Sched IV
