Chapter 4 of 412.5% of exam

Federal Requirements

Federal law defines how controlled substances are scheduled, ordered, recorded, and destroyed, and how the FDA and USP regulate product safety and compounding. This chapter also covers patient privacy, the rules a technician touches on nearly every shift.

Controlled Substance Schedules

The Controlled Substances Act ranks drugs in five schedules according to abuse potential, accepted medical use, and dependence risk. The lower the schedule number, the tighter the controls. Knowing the schedule tells you the refill, storage, and recordkeeping rules that follow.

Schedule I
These substances have a high potential for abuse and no currently accepted medical use in the United States, so they cannot be prescribed and are limited to approved research.
Controlled Substances Act, 21 USC 812
Schedule II
High abuse potential with accepted medical use and severe dependence risk, including many opioid analgesics, stimulants used for attention disorders, and certain barbiturates.
Controlled Substances Act, 21 USC 812
Schedule III
Abuse potential less than Schedules I and II, with moderate to low physical dependence and high psychological dependence, including certain combination products and anabolic steroids.
Controlled Substances Act, 21 USC 812
Schedules IV and V
Schedule IV has lower abuse potential than Schedule III and includes many benzodiazepines, while Schedule V has the lowest potential and includes limited-quantity cough preparations containing codeine.
Controlled Substances Act, 21 USC 812
Pseudoephedrine sales limits
Nonprescription products containing pseudoephedrine must be kept behind the counter, sold within daily and monthly quantity limits, and logged with purchaser identification.
Combat Methamphetamine Epidemic Act of 2005

Prescribing and Dispensing Controlled Substances

A controlled substance prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of practice. Refill and transfer rules tighten as the schedule number decreases. The pharmacist, not the technician, resolves any doubt about legitimacy.

No refills on Schedule II
A Schedule II prescription may not be refilled, so each fill requires a new prescription from the prescriber.
21 CFR 1306.12
Emergency Schedule II dispensing
In a genuine emergency a pharmacist may dispense a limited quantity on an oral order, and the prescriber must deliver a written prescription to the pharmacy within seven days.
21 CFR 1306.11
Refill limits on Schedules III through V
These prescriptions may be refilled up to five times within six months of the date issued, after which a new prescription is required.
21 CFR 1306.22
Partial fills
Partial filling is permitted under defined conditions, including at the request of the patient or prescriber for Schedule II, with the balance supplied within the time limits set by regulation.
21 CFR 1306.13
Required prescription elements
A controlled substance prescription must be dated and signed on the day issued and must show the patient name and address, the prescriber name, address, and DEA registration number, and the drug, strength, quantity, and directions.
21 CFR 1306.05
DEA number verification
Add the first, third, and fifth digits, add the second, fourth, and sixth digits and multiply that sum by two, then add the two results; the last digit of the total must match the final digit of the DEA number.

Controlled Substance Records and Forms

Every controlled substance must be traceable from the wholesaler to the patient or to its destruction. Specific DEA forms document ordering, loss, and disposal. Records have defined retention periods and must be produced on request.

Form 222 and CSOS ordering
Schedule I and II substances may be ordered only using DEA Form 222 or its electronic equivalent through the Controlled Substance Ordering System.
21 CFR 1305
Registration with Form 224
A retail pharmacy applies for DEA registration using Form 224 and renews it periodically to remain authorized to dispense controlled substances.
21 CFR 1301.13
Reporting theft or significant loss
A pharmacy must notify the DEA upon discovering a theft or significant loss and document it on DEA Form 106.
21 CFR 1301.74
Documenting destruction
Controlled substances destroyed by an authorized method are recorded on DEA Form 41.
21 CFR 1317
Biennial inventory
A complete inventory of all controlled substances on hand must be taken at least every two years, with Schedule II records kept separate from other records.
21 CFR 1304.11
Record retention
Controlled substance records must be kept for at least two years and be readily retrievable for inspection by the DEA.
21 CFR 1304.04

FDA Oversight: Recalls, Reporting, and REMS

The FDA polices product safety after approval through recalls, safety communications, and risk management programs. Recall classes rank the seriousness of the hazard. Some drugs may be dispensed only under an approved risk program with extra documentation.

Class I recall
A Class I recall applies when there is a reasonable probability that using the product will cause serious adverse health consequences or death.
21 CFR 7.3
Class II recall
A Class II recall applies when the product may cause temporary or medically reversible adverse health consequences, and the probability of serious harm is remote.
21 CFR 7.3
Class III recall
A Class III recall applies when use of the product is not likely to cause adverse health consequences, such as certain labeling or packaging defects.
21 CFR 7.3
Handling a recall in the pharmacy
Quarantine the affected lots immediately, stop dispensing, follow the manufacturer's return instructions, and notify affected patients as directed by the pharmacist.
Risk Evaluation and Mitigation Strategies
Certain drugs require an approved risk program that may include prescriber and pharmacy enrollment, patient enrollment, laboratory monitoring, and documentation before each dispensing.
Food and Drug Administration Amendments Act of 2007
Medication Guides and drug supply security
Medication Guides must be provided with certain products at each dispensing, and transaction information for prescription drugs must be verified and retained under drug supply chain rules.
Drug Supply Chain Security Act (DSCSA)

USP Compounding Standards and Patient Privacy

USP chapters set the minimum standards for preparing nonsterile, sterile, and hazardous drugs, and each has its own facility, training, and dating requirements. Privacy law governs how patient information is used and disclosed. Both areas generate exam questions about who may do what and with what documentation.

Nonsterile compounding
Nonsterile preparation covers products such as capsules, creams, and oral liquids, and requires trained personnel, a master formulation record, a compounding record, and an assigned beyond-use date.
USP <795>
Sterile compounding
Sterile preparation requires ISO classified air, garbing and hand hygiene, personnel competency testing including media fill, environmental monitoring, and beyond-use dating based on category and storage.
USP <797>
Hazardous drug standard
Facilities that handle hazardous drugs must maintain a written plan, a designated responsible person, containment engineering controls, and documented training for all personnel.
USP <800>
Protected health information
Individually identifiable health information may be used and disclosed for treatment, payment, and health care operations, and otherwise generally requires patient authorization.
HIPAA Privacy Rule
Minimum necessary and safeguards
Disclose only the minimum information necessary for the purpose, and protect records through secure storage, private counseling areas, and controlled system access.
HIPAA Privacy Rule
Notice of Privacy Practices
The pharmacy must give patients a notice describing how their health information is used and disclosed and their rights to access and amend it.
HIPAA Privacy Rule
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Last updated: July 2026

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