Drug Schedules & Controlled Substances (5%)
1. Introduction to Controlled Substances
• Controlled substances are drugs that have abuse
potential or are habit-forming.
• These drugs are strictly regulated in Saudi Arabia
by the SFDA and the Ministry of Health (MoH).
• Includes:
o Narcotics: Pain-relieving drugs with high
abuse potential.
o Psychotropic substances: Drugs affecting
mental state (e.g., antidepressants, anxiolytics).
2. Drug Scheduling in Saudi Arabia
Drugs are divided into Schedules I–V based on:
• Abuse potential
• Medical use
• Risk of dependence
Description Examples Key Rules
Schedule
High abuse,
Schedule Illegal in
no accepted Heroin, LSD
I Saudi Arabia
medical use
No refills
High abuse,
Morphine, allowed;
Schedule medical use
Methadone, written
II allowed with
Oxycodone prescription
restrictions
only
Moderate Codeine with Limited
Schedule
abuse paracetamol, refills
III
potential Buprenorphine allowed
5 refills
Schedule Low abuse Diazepam,
within 6
IV potential Lorazepam
months
May be
Cough syrup available
Schedule Lowest abuse
with <200 mg OTC in
V potential
codeine small
amounts
Note: SFDA maintains an official list of scheduled
drugs. Always refer to the latest circulars for updates.
3. Prescription Rules and Refill Restrictions
General Rules:
• Controlled drugs must be prescribed by a licensed
physician.
• Prescriptions must be:
o Written on official controlled substance Rx
forms
o Include: Patient name, ID, doctor’s stamp and
signature, date, drug details
Schedule II Drugs:
• No verbal or faxed orders accepted.
• No refills allowed.
• Must be dispensed within 7 days of prescription
date.
Schedule III–V Drugs:
• May be refilled up to 5 times within 6 months.
• May accept verbal orders in emergencies (to be
documented later).
• Must maintain strict record-keeping of dispensing.
4. Storage and Security Requirements
A. Storage
• All controlled substances must be:
o Stored in a locked cabinet or safe.
o In a restricted access area.
• Use double-lock systems for high-risk narcotics.
B. Daily Monitoring
• Maintain a daily inventory log for narcotics.
• Match actual stock with system records.
• Perform daily and monthly audits.
5. Record-Keeping Requirements
Essential Records Include:
• Receiving logs: Quantity received, source, date.
• Dispensing records: Patient name, drug, quantity,
dispensing date.
• Loss/damage reports: Details of breakage, spill, or
theft.
• Returned/expired stock: Documented and handled
per policy.
Retention Period:
• Records must be kept for a minimum of 5 years
(as per SFDA and MoH regulations).
• All records should be readily accessible for
inspection.
6. Narcotics Inventory and Reporting
Inventory Control:
• Keep a bound logbook or electronic system with:
o Drug name, strength, quantity
dispensed/received.
o Initials of dispenser and supervisor.
o Running balance.
Discrepancy Management:
• Any shortages, excesses, or errors must be
reported to:
o Pharmacy manager.
o MoH or SFDA, if serious.
• File an incident report and begin investigation.
Expired or Damaged Drugs:
• Segregated and labeled clearly as "Do Not Use".
• Disposal must be:
o Approved by authorities.
o Documented and witnessed by
pharmacist/inspector.
7. Reporting Theft or Loss
• Theft of controlled substances is considered a
serious violation.
• Immediate steps:
o Inform security, SFDA, and local police.
o Secure area and assess extent of loss.
o File a detailed report with lot number,
quantity, and circumstances.
8. Legal and Ethical Responsibilities
• Pharmacy technicians must:
o Never dispense without proper
authorization.
o Avoid altering prescription data.
o Ensure drugs are not diverted for non-medical
or recreational use.
o Report any suspicious activity.
• Unauthorized handling or misuse can result in:
o License revocation
o Fines, jail, or disciplinary action
