Chapter 7.1: The Schedules C-I through C-V

what is FDA and what does it do?

• food and drug administration

• determines if drug is safe and effective for medical use

• decides how a drug is sold

what is DEA and what does it do?

• drug enforcement administration

• steps in when a drug is determined to have a potential for addiction, abuse of physical dependence

what is CSA and what does it do?

• Controlled Substance Act (CSA) passed in 1970

  • decides how drugs are secured

  • uses “closed system” distribution

    • control sub. are tracked from the manufacturer until they reach patients

    • every professional and business involved MUST be registered with DEA to prevent diversion

what is diversion?

• transfer of legal medications from legit medical supply chains to illegal markets

what are schedule I (C-I) drugs?

• illegal and for research purposes only

• federal law does not recognize them as medicine → cannot be prescribed and stocked in pharmacies

• examples of illicit substances: heroine, LSD (lysergic acid diethylamide), peyote (Mescaline), ecstacy (MDMA), psilycybin (mushrooms), and Marijuana (under fed. laws)

• examples of sedatives: methaqualone

what are schedule II (C-II) drugs?

• high risk of abuse → severe psychological and physical dependence

• do have accepted medical use

  • NO REFILLS ALLOWED

  • increased security storage

• pure opioids like hydrocodone, oxycodone, fentanyl, methadone, etc.

• stimulants for ADHD and narcolepsy: Adderall, Vyvanse, Focalin, Ritalin, Concerta

• barbiturates like phenobarbital (nembutal) and secobarbital (seconal)

what are schedule III (C-III) drugs?

• abuse may lead to moderate / low physical dependence but increased psychological dependence

• combined opioid examples:

  • Tylenol #3 + 4: mix must have less than or equal to 90mg of codeine per dosage unit

  • buprenorphine (suboxone, subtex, butrans): for pain and opioid addiction treatment

• anabolic steroid examples:

  • testosterone

  • oxandrolone

• other examples: ketamine (anesthetic for depression), dronabinol (synthetic THC used for appetite stimulation), florinal (butalbital/aspirin/caffeine)

what are schedule IV (C-IV) drugs?

• low risk of abuse

• has many sedatives, anti-anxiety, and sleep aid

• allows up to 5 refills in 6 months

• examples:

  • benzodiazepine (-azolam / -azepam)

  • hypnotics (z-drugs) like ambien, eszopicolone (lunesta), and zaleplon (sonata)

  • muscle relaxants: carisoprodol (soma)

  • pain: tramadol (ultram)

  • weight loss and sleep: phentermine (adipex-p) and modafinil (provigil)

what are schedule V (C-V) drugs?

• lowest potential for abuse

• consist mostly of prep. containing limited quantities of narcotics used for antitussive (cough), antidiarrheal, and analgesic purposes

• examples

  • cough syrups: have small amounts of codeine, guaifenesin w/ codeine, and promethazine w/ codeine

  • antidiarrheals

  • neuropathic pain: pregabalin (lyrica)