Controlled Substances Part 1: The Controlled Substances Act Flashcards
The Drug Enforcement Administration (DEA), under the U.S. Department of Justice (DOJ), enforces the requirements in the Controlled Substances Act (CSA). The DEA publishes the…
Pharmacist’s Manual, which includes the details needed to comply with the CSA.
The DEA determines which drugs should be classified as controlled substances and places them into 1 of 5 schedules (I-V). The schedule is determined based on…
whether the drug has a currently accepted medical use, its relative abuse potential, and the potential for it to cause dependence when abused.
Schedule I drugs have:
no currently accepted medical use; high potential for abuse and lack of accepted safety under medical supervision
Schedule II drugs have:
high potential for abuse; abuse may cause severe psychological or physical dependence
Schedule III drugs have:
Lower abuse potential than schedule I and II; abuse may cause moderate or low potential for physical dependence or high psychological dependence
Schedule IV drugs have:
Low potential for abuse relative to schedule III; abuse may cause limited physical or psychological dependence relative to schedule III
Schedule V drugs have:
Low potential for abuse relative to schedule IV; abuse may cause limited physical or psychological dependence relative to schedule IV
Schedule I:
- 3,4- methylenedioxymethamphetamine or MDMA
- Gamma-hydroxybutyric acid or GHB (the sodium salt form, sodium oxybate, is schedule III)
- Heroin
- LSD
- Marijuana (Cannabis sativa), per the DEA; legalized in some states
- Mescaline
- Peyote
Schedule II:
- alfentanil
- codeine, single ingredient
- fentanyl (Actiq, Duragesic, Fentora, Lazanda, Sublimaze, Subsys)
- hydrocodone, single ingredient (Hysingla ER, Zohydro ER)
- hydrocodone, combo products (Lortab, Norco, TussiCaps, Tussionex, Vicodin, Vicoprofen)
- hydromorphone (Dilaudid)
- levorphanol
- meperidine (Demerol)
- methadone (Methadone HCl Intensol, Methadose)
- morphine (Kadian, MS Contin, Duramorph, Infumorph, Mitigo)
- oxycodone, single ingredient (OxyContin, Roxicodone, Oxayda, Xtampza ER)
- oxycodone, combination products (Endocet, Percocet, Percodan)
- oxymorphone (Opana)
Schedule II:
- paregoric
- sufentanil
- tapentadol (Nucynta, Nucynta ER)
- amphetamine (Adzenys ER, Adzenys ER-ODT, Dyanavel XR, Evekeo, Evekeo ODT)
- amphetamine/dextroamphetamine (Adderall, Adderall XR, Mydayis)
- dexmethylphenidate (Focalin, Focalin XR)
- dextroamphetamine (Dexedrine)
- lisdexamfetamine (Vyvanse)
- Methamphetamine (Desoxyn)
- Methylphenidate (Concerta, Daytrana, Ritalin, Ritalin LA, Adhansia XR, Aptensio XR, Cotempla XR-ODT, Jornay PM, Metadate CD, Methylin, QulliChew ER, Quillivant XR)
- Cocaine
- Dronabinol solution (Syndros)
- Levo-alpha-acetyl-methadol (LAAM)
- Pentobarbital (Nembutal)
- Secobarbital (Seconal)
Schedule III:
- benzphetamine
- buprenorphine, single ingredient (Butrans, Belbuca, Buprenex, Probuphine, Sublocade)
- Buprenorphine/Naloxone (Suboxone, Zubsolv)
- Butabarbital
- Butalbital-containing products (Fioricet*, Fioricet with Codeine, Fiorinal, Fiorinal with Codeine, Allzital, Bupap)
- Codeine/acetaminophen (Tylenol with Codeine #3, Tylenol wih Codeine #4).
- Dronabinol capsules (Marinol)
- Ketamine (Ketalar)
- Perampanel (Fycompa)
- Phendimetrazine
- Sodium oxybate (Xyrem)
- Testosterone and all anabolic steroids (Androderm, AndroGel, Aveed, Depo-Testosterone, Fortesta, Jatenzo, Natesto, Testim, Testopel, Vogelxo, Xyosted)
*state-specific
Schedule IV (benzodiazepines):
- Alprazolam (Alprazolam Intensol, Xanax, Xanax XR)
- Chlordiazepoxide (Librium)
- Clobazam (Onfi, Sympazan)
- Clonazepam (Klonopin)
- Clorazepate (Tranxene-T)
- Diazepam (Diastat AcuDial, Diazepam Intensol, Valium)
- Estazolam
- Flurazepam
- Lorazepam (Ativan, Lorazepam Intensol)
- Midazolam (Versed, Nayzilam, Seizalam)
- Quazepam (Doral)
- Oxazepam
- Remimazolam (Byfavo)
- Temazepam (Restoril)
- Triazolam (Halcion)
Schedule IV (hypnotics):
- Eszopiclone (Lunesta)
- Lemborexant (DayVigo)
- Suvorexant (Belsomra)
- Zaleplon (Sonata)
- Zolpidem (Ambien, Ambien CR, Edluar, Zolpimist)
Schedule IV: weight loss drugs
- Diethylpropion
- Phentermine (Adipex-P, Lomaira)
- Phentermine/Topiramate (Qsymia)
- Others:
- armodafinil (Nuvigil)
- butorphanol (Stadol)
- carisoprodol (Soma)
- difenoxin/atropine (Motofen)
- eluxadoline (Viberzi)
- modafinil (Provigil)
- phenobarbital
- tramadol (Ultram, ConZip)
- tramadol/acetaminophen (Ultracet)
Schedule V:
- brivaracetam (Briviact)
- Codeine containing cough syrups (Cheratussin AC, G Tussin AC, Robitussin A-C, Virtussin A/C)
- Diphenoxylate/atropine (Lomotil)
- Lacosamide (Vimpat)
- Pregabalin (Lyrica, Lyrica CR)
The DEA can reclassify a drug schedule when the perceived risk of abuse or dependence associated with a drug changes. When a scheduling change occurs, a pharmacy must complete an:
inventory of the drug on the date the change becomes effective. After the initial inventory, subsequent inventories are conducted according to the requirements of the new schedule.
States can choose to classify drugs into stricter scheduling categories than the DEA. When state and federal pharmacy law differ, stricter law should be followed. For example, Fioricet is not federally classified as a controlled substance, but California classifies Fioricet as…
schedule III.
Some drugs (eg, barbiturates, codeine, dronabinol) may have varying schedules based on the formulation.
Barbiturates:
- Schedule II: single-entity oral formulations of amobarbital, pentobarbital, and secobarbital
- Schedule III:
- amobarbital, pentobarbital, secobarbital formulated as a suppository
- Amobarbital, pentobarbital, secobarbital in combination with a non-controlled substance
- Butabarbital
- Butalbital-containing products
- Schedule IV: phenobarbital
Codeine Schedules:
- Schedule II: single-entity products
- Schedule III: combination tablets/capsules that contain codeine [eg, acetaminophen 300 mg/codeine 30 mg (Tylenol #3)]
- Schedule V: combination cough syrups that contain codeine (eg, promethazine/phenylephrine HCl/codeine syrup
Dronabinol Schedules:
- Schedule II: oral solution (Syndros), which is 50% alcohol
- Schedule III: oral capsules (Marinol)
Federal law designates marijuana as a schedule I controlled substance. The ratio of THC:CBD contributes…
to a product’s therapeutic efficacy and psychoactive effect.
Epidiolex (cannabidiol), the first FDA-approved CBD-derived product, is indicated for seizures associated with several disorders: Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Initially, the DEA approved Epidiolex in a new classification of schedule V that would include FDA-approved CBD drugs containing no more than 0.1% (w/w) residual THC. However, in 2020, the DEA:
descheduled Epidiolex, so it is now considered a non-controlled drug according to federal and California law.
There are also 2 FDA-approved cannabis-related drugs (ie. not cannabis-derived, like Epidolex):
- Dronabinol: a synthetic delta-9-tetrahydrocannabinol (synthetic THC) approved for AIDS-associated anorexia and chemotherapy-induced nausea and vomiting (CINV). It is available as an oral capsule (Marinol, schedule III) and an alcohol-containing oral solution (Syndros, schedule II).
- Nabilone (Cesamet*, schedule II): a synthetic cannabinoid with a chemical structure similar to THC that is indicated for CINV.
In California, cannabis is regulated less stringently. Medical use of THC was decriminalized in California in 1996. In 2014, non-medical use of cannabis and cannabis products (for adults) was permitted. In California and other states where marijuana is legal, CBD derived from the cannabis plant is…
taxed and regulated.
According to federal law, CBD derived from any source (including hemp) cannot be used in dietary supplements or as food additive since CBD is available as a Rx drug (Epidiolex). However, the DEA has made 2 recent changes pertaining to cannabis products:
- In 2018, the Farm Bill was signed into federal law, which removed hemp from the definition of marijuana in the CSA. Since hemp products are legal, CBD can be extracted from hemp and used in topical products (eg, cream, oil, sprays)
- The FDA still regulates hemp and hemp-derived products, but they are no longer classified as schedule I. This has allowed the retail pharmacist to begin selling CBD-containing topical products in select states, including California.
Pharmacies are not allowed to sell marijuana or drug paraphernalia due to federal law. Even though marijuana is not dispensed in pharmacies, pharmacists should add marijuana to a patient’s medication profile, and be aware of potential drug interactions. CBD and THC are CNS depressants which can…
cause additive side effects. Both are also substrates of several CYP450 enzymes (ie. inducers decrease and inhibitors increase CBD/THC levels.
