Controlled Substances Act and Prescription Requirements

Controlled Substances Overview

  • Definition: Controlled substances are medications that pose a significant potential for abuse.

    • Examples: Opioids, narcotics, amphetamines, sedatives, barbiturates.

Controlled Substances Act of 1970

  • Purpose: Categorized controlled substances into five schedules based on potential for abuse.

  • Regulatory Body: DEA (Drug Enforcement Administration) requires registration for manufacturers, distributors, prescribers, etc.

  • Labeling: Schedules indicated by "C" plus Roman numerals on commercial containers.

The Five Schedules of Controlled Substances

Schedule I (C1)

  • Characteristics: High potential for abuse; no accepted medical uses.

  • Legal Status: Illegal, cannot be prescribed or dispensed by pharmacies.

  • Examples: Heroin, mescaline, peyote, lysergic acid diethylamide (LSD), marijuana (C1 despite some state allowances).

Schedule II (C2)

  • Characteristics: High potential for abuse; can lead to severe psychological/physical dependence.

  • Examples: Morphine, methadone, oxycodone, hydrocodone, fentanyl, methylphenidate, methamphetamine.

  • Prescription Rules:

    • No refills allowed.

    • Quantity limits; remainder must be filled within 72 hours if quantity is unavailable.

Schedule III (C3)

  • Characteristics: Moderate to low potential for abuse.

  • Examples: Ketamine, acetaminophen with codeine, anabolic steroids.

  • Prescription Rules:

    • Can have refills up to 5 times within 6 months.

Schedule IV (C4)

  • Characteristics: Low potential for abuse and dependence.

  • Examples: Diazepam, zolpidem, alprazolam.

  • Prescription Rules:

    • Can have refills up to 5 times within 6 months.

Schedule V (C5)

  • Characteristics: Contains limited quantities of some narcotics and may be available over-the-counter (OTC).

  • Examples: Difenoxylate with atropine, Pregabalin, Guifenacin with codeine.

Prescription Requirements

  • General Requirements:

    • Patient’s full name and address, prescriber’s name, address, phone number, and DEA number.

    • Date issued, number of refills (none for C2 medications).

  • C2 Specific Rules:

    • Validity for prescriptions governed by state law; federal regulations allow faxing prescriptions in certain circumstances.

  • Issuance Protocols: Original Rx must be compared with faxed copy at the time of dispensing.

Record Keeping and Inventory Management

  • C2 Records Management:

    • Must be kept separate from other records.

    • Must maintain records of inventory, receipts, and prescriptions for a minimum of two years.

  • Storage:

    • C2 medications must be stored in a double-locked, tamper-proof narcotics cabinet.

Regulations for Sale of Certain OTC Products

  • Combat Methamphetamine Epidemic Act of 2005: Regulates sales of OTC products containing methamphetamine precursors.

    • Restrictions:

    • ID required for purchase, limit on quantities sold (3.6g/day, 9g/month).

Ordering and Dispensing Controlled Substances

  • Ordering C2 Substances:

    • Use DEA Form 222, which is filled out in triplicate (one copy for supplier, one for DEA, one for pharmacy).

  • Electronic Orders:

    • Pharmacies may use the electronic DEA Controlled Substance Ordering System.

Disposal and Reporting Loss or Theft

  • Disposal Procedures:

    • Use DEA Form 41 for unnecessary medications or expired substances.

    • Options include returning to manufacturer or engaging a reverse distributor.

  • Loss/Theft Reporting:

    • Use DEA Form 106 for reporting losses.

  • Inventory Auditing:

    • Pharmacies perform a complete inventory every two years; stricter regulations for C2 substances.