Controlled Substances Act Summary

Controlled Substances

  • The Controlled Substances Act of 1970 (CSA) classifies drugs into five schedules based on their potential for abuse and medical use.
  • Manufacturers, distributors, and dispensers of controlled substances must register with the DEA.
  • Only registered parties can distribute these drugs.

Controlled Substances Schedules

  • Schedule I: High abuse potential, no accepted medical use. Examples: Heroin, opium derivatives, hallucinogens.
  • Schedule II: High abuse potential, may lead to dependence, accepted medical uses. Examples: Amphetamines, opium, cocaine, methadone.
  • Schedule III: Lower abuse potential than Schedules I and II, accepted medical uses, may lead to moderate physical or high psychological dependence. Examples: Anabolic steroids.
  • Schedule IV: Low abuse potential relative to Schedule III, accepted medical uses, may lead to limited dependence. Examples: Phenobarbital.
  • Schedule V: Low abuse potential relative to Schedule IV, accepted medical uses, may lead to limited dependence. Examples: Compounds with limited amounts of codeine.

Regulations

  • Manufacturers must label controlled drugs with their control classification.
  • Distributors must maintain records of controlled substance activity (Schedule II: 7 years, others: 2 years).
  • Schedule II drugs are stored in locked, tamper-proof cabinets.
  • Prescribers and dispensers share responsibility for the legitimate medical purpose of prescriptions.
  • Prescribers must have a DEA number, which must be on all controlled drug prescriptions.

DEA Form 222

  • Used to order Schedule I and II substances.
  • Filled out in triplicate; copies retained by supplier, DEA, and purchaser.
  • Purchaser records container count and receipt dates on their copy.
  • Forms have unique serial numbers and must be kept for 2 years.
  • C-III-C-V do not require federal order forms.

Controlled Substances Prescriptions

  • Schedule II prescriptions have stricter requirements.
  • DEA number and patient's address must be on the prescription.
  • Prescriptions must be signed by the prescriber.
  • Quantities are limited, and refills are generally not allowed.
  • Faxed prescriptions are allowed for Schedules III-V, and may be refilled up to five times within a six-month period.

DEA Number Verification

  • DEA numbers have two letters followed by seven digits.
  • Formula: Add the sum of the 1st, 3rd, and 5th digits to twice the sum of the 2nd, 4th, and 6th digits; the total's last digit should match the DEA number's last digit.
  • Example: For AB1234563, (1+3+5)+2∗(2+4+6)=33(1+3+5)+2*(2+4+6) = 33, which is consistent as the last digit is 3.