Federal Requirements practice questions

Answer: A) As a Schedule IV controlled substance

A DEA final rule published December 12, 2011 and effective January 11, 2012 placed carisoprodol (Soma) in federal Schedule IV.

• ACorrect. The DEA placed carisoprodol in Schedule IV through a final rule that took effect January 11, 2012.
• BIncorrect. HHS recommended Schedule IV for carisoprodol, and the DEA placed it there, not in Schedule III.
• CIncorrect. Carisoprodol is not in Schedule II, which covers drugs with the highest abuse potential that still have an accepted medical use, such as oxycodone.
• DIncorrect. Some states controlled carisoprodol earlier, but it has been federally controlled since the 2012 DEA rule and is no longer a noncontrolled legend drug.

Answer: B) FDA's most prominent labeling warning, used to highlight serious or life-threatening risks

A boxed warning is FDA's most prominent labeling warning, placed at the start of the prescribing information to call out serious or life-threatening risks. It is not an auxiliary label, a DEA schedule symbol, or a REMS.

• AIncorrect. Auxiliary labels are optional stickers a pharmacy puts on dispensed containers. A boxed warning is part of the FDA-required labeling for the product and covers serious risks, not mild ones.
• BCorrect. FDA describes the Boxed Warning as its most prominent warning. It is required when a drug carries a significant risk of serious or life-threatening adverse effects, as with the benzodiazepine class.
• CIncorrect. Controlled-substance status is shown by the DEA schedule symbol (for example, C-II). Many boxed-warning drugs are not controlled, and many controlled drugs have no boxed warning.
• DIncorrect. A REMS is a separate risk-management program that may restrict distribution. Some drugs with boxed warnings have no REMS, so the two terms are not the same.

Answer: B) Schedule III

• AIncorrect. Schedule II includes drugs such as oxycodone and amphetamine.
• BCorrect. Anabolic steroids, including testosterone, are Schedule III.
• CIncorrect. Schedule IV includes drugs such as zolpidem.
• DIncorrect. Schedule V includes drugs such as pregabalin.

Answer: B) MedWatch

• AIncorrect. VAERS collects reports about vaccines, not other drugs.
• BCorrect. MedWatch is the FDA's safety information and adverse event reporting program.
• CIncorrect. CSOS is the DEA's electronic ordering system for controlled substances.
• DIncorrect. iPLEDGE is the isotretinoin REMS program.

Answer: A) Schedules II, III and IV

• ACorrect. Federal rules require the transfer warning on Schedule II–IV prescription labels.
• BIncorrect. The warning covers Schedules II through IV.
• CIncorrect. Schedule I drugs are not dispensed on prescriptions.
• DIncorrect. The warning is required for Schedules II–IV.

Answer: A) A signed paper prescription, a fax of a signed paper prescription, a compliant electronic prescription, or an oral prescription from the practitioner

Under 21 CFR 1306.21(a), a Schedule III–V prescription may be a signed paper prescription, a fax of one, an electronic prescription or an oral prescription from the practitioner. Schedule II prescriptions follow stricter rules.

• ACorrect. 21 CFR 1306.21(a) permits Schedule III–V dispensing under any of these four forms. An oral prescription must be promptly reduced to writing by the pharmacist.
• BIncorrect. The emergency oral order with written follow-up within 7 days is the Schedule II rule in 21 CFR 1306.11(d). For Schedule III–V drugs, oral prescriptions are routinely allowed.
• CIncorrect. Federal regulations still allow paper, faxed and oral prescriptions for Schedule III–V drugs alongside electronic ones.
• DIncorrect. Electronic prescriptions that meet parts 1306 and 1311 are allowed for Schedules II through V, not just Schedule II.

Answer: B) The prescriber directs it in the order, or the patient asks for it

The PPPA allows a prescription to be dispensed in a non-child-resistant container only when the prescriber directs it in the order or the purchaser requests it.

• AIncorrect. The pharmacist's own judgment about the patient's age does not waive the requirement. Only the prescriber or the purchaser can ask for noncomplying packaging.
• BCorrect. The PPPA allows a prescription to be dispensed in noncomplying packaging when the prescriber directs it in the order or when the purchaser (patient) requests it.
• CIncorrect. A technician's note about the household is not a basis for an exemption. The request must come from the prescriber or the purchaser.
• DIncorrect. Adult-use labeling by the manufacturer does not exempt a dispensed prescription from child-resistant packaging.

Answer: B) 503B outsourcing facilities

• AIncorrect. It created 503B outsourcing facilities.
• BCorrect. They follow current good manufacturing practices.
• CIncorrect. It created 503B outsourcing facilities.
• DIncorrect. It created 503B outsourcing facilities.

Answer: D) Paying or receiving value for federal program referrals

• AIncorrect. It targets payments for referrals.
• BIncorrect. It targets payments for referrals.
• CIncorrect. It targets payments for referrals.
• DCorrect. Violations can bring criminal penalties.

Answer: A) Schedule II

• ACorrect. Morphine is a Schedule II opioid.
• BIncorrect. It's Schedule II.
• CIncorrect. It's Schedule II.
• DIncorrect. It's Schedule II.