CDSA, NSAA, EA

• Controlled Substances


  Drug classes that require rigorous government control, primarily for human safety and to ensure legitimate therapeutic use
• Categories of controlled substances

  • Narcotics
  • Controlled drugs
  • Targeted substances
• Controlled Drugs and Substances Act (CDSA)


  A federal statute that applies to narcotics, controlled drugs, and targeted substances, regulating their manufacture, import, export, distribution, and sale
• CDSA


  1. Provides a framework to control production, import, export & distribution of controlled substances

  2. Provides enforcement measures to police & courts for unlawful import, export, production & distribution of controlled substances
• Responsibilities of pharmacists under CDSA


  Ordering, dispensing, and recording the sale and purchase of controlled substances
• Responsibilities of prescribers under CDSA

  Additional rules and regulations to prescribe controlled substances to patients
• CDSA Schedules


  • Schedule I: Narcotics (e.g. opium, cocaine, methadone)
  • Schedule II: Synthetic cannabinoids
  • Schedule III: Controlled drugs (e.g. amphetamines, LSD)
  • Schedule IV: Barbiturates, benzodiazepines, anabolic steroids
  • Schedule V: Phenylpropanolamine, prophylhexedrine, pyrovalerone
  • Schedule VI: Ephedrine, pseudoephedrine, ergotamine
  • Schedule VII: Repealed
  • Schedule VIII: Repealed
  • Schedule IX: Devices that may be used to produce solid tablets or fill capsules
• CDSA Regulations affecting pharmacy practice

  • Narcotic Control Regulations
  • Benzodiazepines and Other Targeted Substances Regulations
  • Precursor Control Regulations
  • New Classes of Practitioners Regulations
• Definitions of narcotic drugs

  • Narcotics (aka, straight or reportable)
  • Verbal prescription narcotics
  • Exempted narcotic preparations
• Straight or reportable narcotic drug

  Meets one of the following criteria: 1) single narcotic drug, 2) narcotic + 1 active non-narcotic ingredient, 3) all parenteral narcotics, 4) all products containing hydrocodone, oxycodone, methadone, pentazocine, or heroin
• Examples of straight or reportable narcotic drugs

  • morphine sulfate
  • meperidine
  • hydromorphone
  • oxycodone
  • fentanyl
  • Tylenol #4
• Verbal prescription narcotic drug

  Contains a narcotic plus two or more other medicinal ingredients, is not for parenteral administration, and does not contain hydrocodone, methadone, oxycodone or pentazocine
• Examples of verbal prescription narcotic drugs

  • Tylenol #2
  • Tylenol #3
  • Atasol 15
  • Atasol 30
  • Fiorinal C1/2
  • Dimetapp C
  • Robitussin AC
• Exempted narcotic (codeine) preparations


  Narcotic formulations that can be purchased without a prescription, with pharmacist intervention required at point of sale
• Examples of exempted narcotic (codeine) preparations

  • Tylenol #1
  • Robaxacet-8
  • Calmylin
  • Mersyndol
• Purchasing straight narcotic drugs

  1. Can only be purchased by written or electronic means, with a signature or code of a pharmacist with signing authority

  2. A written order must be submitted to the distributor within 5 working days

  3. A record of purchase must be maintained
• Prescription requirements for straight narcotic drugs

  1. Written or faxed

  2. No repeats (refills) allowed

  3. Part fills allowed when total quantity is specified

  4. No transfers of part fills allowed

  5. Sales record entry required
• Prescription requirements for narcotic preparations (verbal narcotics)

  1. Verbal, faxed or written prescriptions allowed

  2. No repeats (refills) allowed

  3. Part fills allowed when total quantity is specified

  4. No transfers of part fills allowed

  5. Verbal prescriptions can be taken by pharmacists, registered pharmacy students and interns under direct supervision
• The following are not acceptable: i-ii prn for 10 days, ii q 6-8h x 10 days, i-ii qid x 5 days
• Narcotic possession


  Who may possess narcotics: 1) for business or profession (MD, RPh, licensed dealer), 2) someone who received pursuant to a prescription (or a patient's agent), 3) hospital employee / hospital practitioner
• Narcotic purchase record keeping

  1. Records must be maintained either manually or electronically, stating name, quantity, date, and name/address of licensed dealer

  2. Records must be kept for 2 years in chronological order and easily retrievable
• Narcotic sales record keeping

  1. All sales of reportable narcotics and controlled drugs must be recorded with fill date, Rx number, drug name/form/strength/quantity, patient name/address, prescriber name/address

  2. Pharmacy software automatically records these details
• Manual sales record entries

  Required for sales to another pharmacy, and for verbal narcotic/controlled drug preparations dispensed to a practitioner for their own or family use
• Emergency narcotic supply


  1. A pharmacist may supply another pharmacist with a quantity of narcotic for emergency purposes upon receipt of a written order

  2. The quantity supplied should be just enough to fill one particular prescription

  3. The sales record must be maintained even for verbal narcotics
• Loss of narcotics


  • Includes theft, forgeries, damaged/mishandled/expired drugs, miscounts
  • Must be reported to the Office of Controlled Substances within 10 days of discovery
• Destruction of out-of-date narcotics

  1. Full unopened bottles may be returned to manufacturer/distributor

  2. Damaged, unserviceable or outdated narcotics, controlled and targeted drugs must be destroyed in the presence of a witness (another pharmacist, intern or technician)

  3. The destruction process must be recorded and records kept for 2 years
• Narcotic reconciliation


  A tool to monitor inventory and protect against diversion and theft
• Supplying narcotics to another pharmacist

  1. Receive written order signed and dated

  2. Supply just enough to fill one particular prescription

  3. Maintain record of sales even for verbal narcotics
• Types of narcotic loss

  • Theft
  • Forgeries
  • Damaged drugs
  • Mishandled drugs
  • Expired drugs
  • Miscounts - either through manufacturer or through dispensing
• Reporting loss of narcotics


  1. Report to Office of Controlled Substances

  2. Within 10 days of discovery
• Forms for reporting loss/theft of narcotics

  • Forgery Report Form
  • Loss or Theft Report Form
• Destruction of out of date narcotics

  1. Return full unopened bottles to manufacturer/distributor

  2. Destroy damaged, unserviceable or outdated narcotics, controlled and targeted drugs

  3. Destruction must be done in presence of witness

  4. Destruction process must be recorded

  5. Records kept for 2 years
• Narcotic reconciliation


  Tool to monitor inventory, protect from diversion and theft, detailed audit that shows on hand to purchases made, used to identify problems in dispensing and loss
• Frequency of narcotic reconciliation

  Based on volume of narcotics dispensed, number of staff having access to inventory, regular six month check and small random spot checks
• FDA Schedule G


  • Part I: All straight controlled drugs and all combinations with more than one controlled drug
  • Part II: Most barbiturates
  • Part III: Anabolic steroid and derivatives
• Reportable controlled drugs


  Listed in Schedule III, part 1 of CDSA
• Reportable controlled drugs


  • Dexedrine (dextroamphetamine)
  • Ritalin (methylphenidate)
• Rules for reportable controlled drugs

  Similar to verbal narcotics, except refills are allowed and sales record must be maintained, time interval between refills or dates must be stated
• Prescription refills for reportable controlled drugs

  Valid only if it is a written prescription, not valid if interval or dates of dispensing are not stated
• Other controlled drugs


  • Anabolic steroids (Androgel, Androderm, Andriol, Depo-Testesterone)
  • Bellergal spacetabs
  • Fiorinal tablets or capsules