CSLB General Building (B) — All Questions

Which drug is placed in Schedule II (C-II), the schedule with an accepted medical use but the highest abuse potential of any prescribable controlled substance?

• a.Alprazolam
• b.Hydromorphone✓
• c.Pregabalin
• d.Ketamine

Hydromorphone is a C-II opioid; other common C-II agents include oxycodone, fentanyl, methylphenidate, and amphetamine. Alprazolam is C-IV, pregabalin is C-V, and ketamine is C-III, so all three carry a lower federally assigned abuse potential. Schedule II drugs have accepted medical use but the greatest abuse and dependence risk among drugs that may still be prescribed.21 CFR 1308 (DEA schedules)

Under the Controlled Substances Act, which statement correctly describes Schedule I substances such as heroin and LSD?

• a.They have a low abuse potential and may be sold over the counter.
• b.They may be dispensed by prescription but never refilled.
• c.They may be dispensed with up to 5 refills in 6 months.
• d.They have a high abuse potential and no currently accepted medical use in the United States, so they cannot be prescribed.✓

The defining feature of Schedule I is a high potential for abuse combined with no currently accepted medical use in the United States, which is why these substances are not dispensed on an outpatient prescription. Over-the-counter sale is impossible for any Schedule I substance, and the no-refill rule describes Schedule II, while the 5-refills-in-6-months rule describes Schedules III and IV. Schedule I products are limited to registered research and other DEA-authorized activity.21 CFR 1308 (DEA schedules)

What is DEA Form 222 (or its electronic CSOS equivalent) used for?

• a.Ordering or transferring Schedule II controlled substances between DEA registrants✓
• b.Reporting a theft of controlled substances to the DEA
• c.Documenting the destruction of expired controlled substances
• d.Registering a new pharmacy with the DEA

DEA Form 222, or an electronic order placed through the Controlled Substance Ordering System (CSOS), is required for every purchase or transfer of a Schedule II substance between registrants. Schedules III through V may be ordered on an ordinary invoice and do not require Form 222, although the invoice must still be retained. Theft reporting uses Form 106, destruction uses Form 41, and initial pharmacy registration uses Form 224.21 CFR 1305 (DEA Form 222 / CSOS)

A pharmacy destroys a quantity of expired Schedule II tablets on site. Which DEA form documents this disposal?

• a.DEA Form 224
• b.DEA Form 106
• c.DEA Form 41✓
• d.DEA Form 222

DEA Form 41 is the registrant's record of controlled substances that have been destroyed, and it must be retained with the pharmacy's controlled substance records. Form 106 is reserved for theft or significant loss, Form 222 is for ordering Schedule II drugs, and Form 224 is the pharmacy's DEA registration application. Destruction records are kept for at least 2 years under federal law; some states are stricter.21 CFR 1307 (DEA Form 41 destruction)

During a routine count the pharmacy discovers that a sealed bottle of oxycodone is missing and suspects diversion. Which action does federal law require?

• a.Record the shortage on the next biennial inventory only
• b.Notify the DEA and submit DEA Form 106 for the theft or significant loss✓
• c.Complete DEA Form 41 to document the missing product
• d.Submit a new DEA Form 222 to replace the lost stock

A theft or significant loss of controlled substances must be reported to the DEA, and Form 106 is the report used to document the circumstances and quantities involved. Form 41 records product that was intentionally destroyed, not product that disappeared, and Form 222 only orders Schedule II stock. Simply noting the discrepancy at the next inventory does not satisfy the reporting duty; state boards often require notification as well.DEA

How often must a DEA registrant take a complete inventory of all controlled substances on hand?

• a.Every 2 years✓
• b.Every 12 months
• c.Every 6 months
• d.Every 5 years

Federal law requires a biennial inventory, meaning a complete count of controlled substances on hand at least every 2 years, in addition to the initial inventory taken when the registrant begins handling controlled substances. Annual, semiannual, and five-year cycles are not the federal standard, although some states require inventories more often. Schedule II records must be kept separate from all other records and all controlled substance records must be readily retrievable and kept at least 2 years; this is a federal minimum and some states are stricter.21 CFR 1304 (controlled substance records)

A patient presents a written prescription for a Schedule IV benzodiazepine. What is the federal refill limit?

• a.No refills are permitted
• b.Unlimited refills for 12 months from the date written
• c.Up to 3 refills within 12 months of the date written
• d.Up to 5 refills within 6 months of the date written✓

Schedule III and Schedule IV prescriptions may be refilled a maximum of 5 times and only within 6 months of the date the prescription was written, whichever limit is reached first. The no-refill option describes Schedule II, which may not be refilled at all, and neither unlimited refills for a year nor a 3-refill cap matches the federal rule for C-III and C-IV. This is a federal minimum; some states are stricter.21 CFR 1306 (controlled substance prescriptions)

A manufacturer recalls a sterile injectable after finding particulate matter that could cause fatal embolism. How does the FDA classify this recall?

• a.Class III
• b.Class II
• c.Class I✓
• d.Class IV

A Class I recall applies when there is a reasonable probability that use of the product will cause serious adverse health consequences or death, which fits a contaminant capable of causing a fatal event. Class II covers products that may cause temporary or medically reversible harm, and Class III covers products unlikely to cause any adverse health consequence, such as a minor labeling defect. There is no Class IV in the FDA recall classification system.21 CFR 7 (FDA recall classification)

Which statement best describes a Risk Evaluation and Mitigation Strategy (REMS)?

• a.A DEA program that limits how much of a controlled substance a pharmacy may order each month
• b.An FDA-required safety program that may mandate prescriber certification, patient enrollment, pharmacy certification, or laboratory monitoring before a drug is dispensed✓
• c.A USP standard that sets beyond-use dates for compounded preparations
• d.A manufacturer's voluntary coupon program that lowers patient copays for specialty drugs

A REMS is imposed by the FDA when a drug's serious safety risks require controls beyond standard labeling, and its elements can include certifying prescribers and pharmacies, enrolling patients in a registry, and documenting laboratory results before dispensing. Familiar examples are iPLEDGE for isotretinoin, absolute neutrophil count monitoring for clozapine, and the restricted program for thalidomide. Ordering quotas are a DEA function, beyond-use dating is set by USP compounding standards, and copay assistance has no regulatory safety role.FDA REMS (FDAAA 2007)

Which standard governs compounded sterile preparations, including ISO-classified air, garbing, and assignment of beyond-use dates?

• a.USP <795>
• b.USP <800>
• c.USP <797>✓
• d.21 CFR 1304

USP <797> sets the practice standards for compounded sterile preparations, covering ISO-classified engineering controls, personnel hand hygiene and garbing, environmental monitoring, and beyond-use dating. USP <795> applies to nonsterile compounding such as creams and oral suspensions, while USP <800> addresses handling of hazardous drugs regardless of whether the preparation is sterile. 21 CFR 1304 concerns controlled substance recordkeeping and has nothing to do with compounding technique.USP <797>

A technician will compound a chemotherapy agent in a negative-pressure containment room while wearing a chemotherapy-rated gown and two pairs of chemotherapy-rated gloves. Which standard drives these requirements?

• a.USP <800>✓
• b.USP <795>
• c.USP <797>
• d.Drug Supply Chain Security Act (DSCSA)

USP <800> governs the receipt, storage, compounding, and disposal of hazardous drugs in order to protect personnel, patients, and the environment, and it specifies containment engineering controls such as negative pressure rooms plus chemotherapy-rated PPE. Drugs subject to <800> are identified from the NIOSH hazardous drug list. USP <795> and <797> address nonsterile and sterile compounding quality rather than worker exposure, and the DSCSA deals with tracing product through the supply chain.USP <800>

Which action by a pharmacy technician violates the HIPAA Privacy Rule?

• a.Submitting a claim with the patient's medication details to the patient's insurer
• b.Faxing a refill history to the prescribing physician who is managing the patient's therapy
• c.Providing patient records to the pharmacist for an internal medication error review
• d.Telling the patient's neighbor which medications the patient picked up that morning✓

Protected health information may be used or disclosed without separate patient authorization for treatment, payment, and health care operations, and disclosures must be limited to the minimum necessary for the purpose. Billing the insurer is payment, faxing the prescriber is treatment, and an internal error review is health care operations, so all three are permitted. Disclosing a patient's medications to a neighbor serves none of these purposes and is a privacy violation.HIPAA Privacy Rule (45 CFR 164)

Under the Combat Methamphetamine Epidemic Act, what is the federal daily purchase limit of pseudoephedrine base for a single buyer?

• a.9 g
• b.2.4 g
• c.3.6 g✓
• d.7.5 g

The CMEA caps a single purchaser at 3.6 g of pseudoephedrine base per day and 9 g in a 30-day period, so 9 g is the monthly limit rather than the daily one and 2.4 g and 7.5 g are not federal thresholds. Products must be kept behind the counter or in a locked case, and the buyer must show photo identification and sign a written or electronic logbook that is retained for 2 years. These are federal minimums; some states are stricter and require a prescription.Combat Methamphetamine Epidemic Act (CMEA)