PTCB Practice Test 2 | Federal Requirements

Schedule II prescriptions may be faxed only in emergency situations. The prescriber must provide a follow-up written prescription within seven days.

Under the Combat Methamphetamine Epidemic Act (CMEA), a customer can purchase no more than 3.6 grams of pseudoephedrine in a single day. This law prevents the illicit production of methamphetamine.

When a pharmacy loses DEA privileges, its remaining controlled substance inventory must be returned to a DEA-registered reverse distributor for proper disposal.

Expired Schedule II drugs must be destroyed using DEA-approved methods and documented with DEA Form 41 to prevent diversion.

Schedule II prescriptions must have a specific dosage schedule. “As needed” instructions are not permitted under federal law, requiring a new prescription with clear instructions.

Schedule II prescriptions require a valid DEA number. The pharmacy must verify the prescriber’s registration before dispensing to ensure compliance with federal law.

Schedule II prescriptions cannot be transferred except in special cases, such as electronic prescriptions for unfilled medications.

DEA Form 222 is required to order Schedule II drugs. This form ensures accountability and prevents unauthorized distribution.

Methadone can only be dispensed for opioid addiction in DEA-registered opioid treatment programs (OTPs). However, it can be dispensed for pain management with a valid prescription.

Significant losses of controlled substances must be reported to the DEA immediately using Form 106 to prevent diversion and ensure compliance.

Schedule I drugs (e.g., heroin, LSD) have no accepted medical use and are considered highly dangerous with a high potential for abuse.

Schedule III drugs can have refills but must follow strict refill timeframes. If an early refill is requested, prescriber authorization is needed to ensure compliance.

The DEA enforces the Controlled Substances Act, regulating the manufacture, distribution, and dispensing of controlled substances to prevent misuse and diversion.

The Health Insurance Portability and Accountability Act (HIPAA) protects patient privacy and mandates secure handling of medical and prescription records.

Schedule III drugs can be refilled up to five times in six months, but refills must follow time restrictions. Early refills require prescriber authorization to ensure compliance.

Schedule V drugs, such as certain cough syrups with codeine, may be available OTC in some states with proper documentation.

Schedule II drugs require strict documentation. If an extra bottle is received, it must be returned to the supplier with a corrected DEA Form 222 to maintain compliance.

Expired controlled substances should be transferred to a DEA-registered reverse distributor for proper disposal, ensuring regulatory compliance and preventing diversion.

Expired Schedule II drugs must be destroyed following DEA regulations and documented using DEA Form 41.

All controlled substances must be stored securely to prevent theft and unauthorized access, following DEA regulations.

The DEA requires reporting of controlled substance theft or significant loss immediately using DEA Form 106. Delaying reporting or failing to report may result in severe penalties.

Pharmacies should direct patients to DEA take-back programs or authorized collection sites for safe disposal of unused controlled substances.

Under the Combat Methamphetamine Epidemic Act (CMEA), pseudoephedrine sales require a government-issued ID to track purchases and prevent misuse in methamphetamine production.

The FDA enforces drug labeling requirements, recalls unsafe drugs, and ensures compliance with safety standards.

The DEA’s National Prescription Drug Take-Back program allows consumers to return unused medications for safe disposal, preventing misuse and environmental contamination.

Methylphenidate (Schedule II) must be stored in a secure, locked location or dispersed throughout inventory to prevent theft. Schedule III-V drugs have less stringent storage requirements.

Schedule III-V prescriptions can have up to five refills in six months, but no more. Pharmacies must monitor refill compliance closely.

Schedule II drugs require a written prescription and cannot be refilled to prevent misuse and diversion.

DEA Form 224 is used by pharmacies to register with the DEA for legal authorization to dispense controlled substances.

Investigational drugs require an FDA-approved IND application before they can be dispensed to patients in clinical trials.

Schedule II drugs require DEA Form 222 for transfers, ensuring accurate tracking and preventing unauthorized distribution.

Schedule III-V prescriptions can be transferred once between pharmacies if refills remain. The transfer must be documented according to DEA regulations.

Emergency Schedule II prescriptions may be taken verbally but must be followed up with a written prescription within 7 days to remain compliant with federal law.

Schedule II drug transfers require DEA Form 222 to document and track controlled substance movement.

Controlled substances in long-term care facilities must be securely stored and properly labeled. Unused medications should be destroyed following DEA guidelines to prevent diversion.

Pharmacists must first verify a suspicious prescription with the prescriber. If fraud is suspected, it should be reported to the DEA and not filled.

Before dispensing investigational controlled substances, they must have an FDA-approved IND application to ensure safety and regulatory compliance.

Pharmacies must report suspected controlled substance diversion to the DEA immediately using DEA Form 106 to prevent drug misuse and ensure compliance with federal law.

Pharmacies must verify out-of-state controlled substance prescriptions for legitimacy. If suspicious patterns persist, they should report the issue to the DEA.

For Class II recalls (moderate health risk), affected drugs should be quarantined immediately while awaiting further instructions from the manufacturer or FDA.

Schedule IV drugs, such as alprazolam, can be refilled up to five times within six months. Schedule II drugs, like fentanyl and methadone, cannot be refilled.

The Controlled Substances Act (CSA) establishes DEA schedules based on abuse potential and medical use, regulating prescription, distribution, and handling.

DEA take-back programs allow patients to return unused medications for safe disposal, reducing the risk of drug diversion and environmental harm.

Codeine-containing combination products are Schedule III because they have a moderate potential for abuse, unlike Schedule II opioids such as oxycodone and morphine.

Partial Schedule II orders may be completed within 60 days from the initial order date, following DEA regulations to prevent supply issues.

For unclaimed prescriptions, pharmacies must document the return to inventory to ensure proper tracking of controlled substances.

Multiple Schedule II prescriptions must have clearly written future fill dates. Without these dates, the pharmacy cannot dispense future fills.

All controlled substance discrepancies must be resolved with the supplier first before adjusting inventory records to ensure compliance with DEA regulations.

Antibiotics are classified as non-hazardous pharmaceutical waste and can be disposed of following standard pharmacy waste guidelines.

DEA violations, especially missing documentation for controlled substances, may result in fines, legal action, or revocation of DEA privileges, depending on severity and intent.