PTCB Pharmacy Technician (PTCE) — All Questions

Which brand name corresponds to the generic drug atorvastatin?

• a.Zocor
• b.Pravachol
• c.Crestor
• d.Lipitor✓

Atorvastatin is marketed under the brand name Lipitor. Zocor is simvastatin, Crestor is rosuvastatin, and Pravachol is pravastatin; all four are statins, which is why the names are easily confused.

A patient brings in a prescription written for Synthroid. What is the generic name of this medication?

• a.Propylthiouracil
• b.Methimazole
• c.Liothyronine
• d.Levothyroxine✓

Synthroid is the brand name for levothyroxine, a synthetic T4 thyroid hormone. Liothyronine is synthetic T3 (Cytomel), while methimazole and propylthiouracil are antithyroid agents used for hyperthyroidism, not replacement therapy.

Prinivil and Zestril are brand names for which generic drug?

• a.Losartan
• b.Enalapril
• c.Ramipril
• d.Lisinopril✓

Lisinopril is sold as both Prinivil and Zestril. Enalapril (Vasotec) and ramipril (Altace) are different ACE inhibitors, and losartan (Cozaar) is an angiotensin II receptor blocker rather than an ACE inhibitor.

Which generic medication is sold under the brand name Glucophage?

• a.Glipizide
• b.Metformin✓
• c.Pioglitazone
• d.Glyburide

Glucophage is the brand name for metformin. Glipizide (Glucotrol) and glyburide (DiaBeta) are sulfonylureas, and pioglitazone (Actos) is a thiazolidinedione; all lower blood glucose but by different mechanisms.

A patient picks up a refill for Norvasc 5 mg tablets. Which generic name should appear on the label?

• a.Amlodipine✓
• b.Atenolol
• c.Nifedipine
• d.Diltiazem

Norvasc is amlodipine, a dihydropyridine calcium channel blocker. Atenolol (Tenormin) is a beta blocker, while nifedipine (Procardia) and diltiazem (Cardizem) are other calcium channel blockers sold under different brand names.

Omeprazole is marketed under which brand name?

• a.Protonix
• b.Prevacid
• c.Prilosec✓
• d.Nexium

Omeprazole is sold as Prilosec. Protonix is pantoprazole, Nexium is esomeprazole, and Prevacid is lansoprazole; all four are proton pump inhibitors with similar-sounding generic endings.

What is the generic name of Zoloft?

• a.Fluoxetine
• b.Sertraline✓
• c.Citalopram
• d.Paroxetine

Zoloft is the brand name for sertraline. Fluoxetine is Prozac, paroxetine is Paxil, and citalopram is Celexa; all are selective serotonin reuptake inhibitors used for depression and anxiety disorders.

Gabapentin is dispensed under which of the following brand names?

• a.Topamax
• b.Lyrica
• c.Keppra
• d.Neurontin✓

Gabapentin is marketed as Neurontin. Lyrica is pregabalin, Keppra is levetiracetam, and Topamax is topiramate; all are anticonvulsants, and pregabalin is structurally the closest relative to gabapentin.

Which generic diuretic corresponds to the brand name Lasix?

• a.Hydrochlorothiazide
• b.Bumetanide
• c.Spironolactone
• d.Furosemide✓

Lasix is furosemide. Bumetanide (Bumex) is another loop diuretic, hydrochlorothiazide is a thiazide, and spironolactone (Aldactone) is a potassium-sparing aldosterone antagonist.

A generic drug name ending in the suffix '-sartan' indicates that the medication belongs to which class?

• a.ACE inhibitors like ramipril
• b.Angiotensin II receptor blockers✓
• c.Calcium channel blockers (CCBs)
• d.Beta blockers like atenolol

The '-sartan' stem identifies angiotensin II receptor blockers such as losartan and valsartan. Ramipril is an ACE inhibitor, and that class carries the '-pril' stem; atenolol is a beta blocker, and that class carries the '-olol' stem; dihydropyridine calcium channel blockers carry the '-dipine' stem.

Alprazolam (Xanax) is a benzodiazepine. Under federal law, benzodiazepines such as alprazolam are placed in which DEA schedule?

• a.Schedule V
• b.Schedule III
• c.Schedule II
• d.Schedule IV✓

Benzodiazepines, including alprazolam, are Schedule IV controlled substances. Schedule II includes drugs such as oxycodone and amphetamine, Schedule III includes products such as ketamine and some anabolic steroids, and Schedule V includes low-dose codeine cough preparations.21 CFR 1308 (DEA schedules)

Pantoprazole belongs to which drug class?

• a.Proton pump inhibitor✓
• b.H2 receptor antagonist
• c.Prostaglandin analog
• d.Antacid

Pantoprazole is a proton pump inhibitor; the '-prazole' stem marks this class, which blocks the gastric H+/K+ ATPase. H2 receptor antagonists include famotidine, antacids are products such as calcium carbonate, and misoprostol is the prostaglandin analog used for gastric protection.

Metformin is classified as which type of antidiabetic agent?

• a.Sulfonylurea
• b.Biguanide✓
• c.DPP-4 inhibitor
• d.Thiazolidinedione

Metformin is the only biguanide in common use; it lowers hepatic glucose production and improves insulin sensitivity. Sulfonylureas such as glipizide stimulate insulin release, thiazolidinediones such as pioglitazone act on PPAR-gamma receptors, and DPP-4 inhibitors such as sitagliptin end in '-gliptin'.

Azithromycin belongs to which class of antibiotics?

• a.Cephalosporin
• b.Tetracycline
• c.Macrolide✓
• d.Fluoroquinolone

Azithromycin is a macrolide, along with erythromycin and clarithromycin. Fluoroquinolones end in '-floxacin', tetracyclines end in '-cycline', and cephalosporins usually begin with 'cef-' or 'ceph-'.

Which of the following medications is a loop diuretic?

• a.Chlorthalidone
• b.Furosemide✓
• c.Spironolactone
• d.Hydrochlorothiazide

Furosemide acts on the ascending loop of Henle and is classified as a loop diuretic. Hydrochlorothiazide and chlorthalidone are thiazide-type diuretics acting on the distal tubule, and spironolactone is a potassium-sparing agent.

In the FDA Orange Book, an 'AB' therapeutic equivalence code means that the product:

• a.Has been approved for the same indications but was never compared with the brand
• b.Has demonstrated bioequivalence and may be substituted for the reference listed drug✓
• c.May be dispensed only with written permission from the prescriber
• d.Contains a different active ingredient that produces a similar effect

An AB code means actual or potential bioequivalence problems have been resolved with adequate in vivo or in vitro data, so the product is therapeutically equivalent to the reference listed drug and can be substituted. It does not mean the ingredient differs, and no special prescriber permission is required beyond ordinary state substitution rules.FDA

A product carries a 'BX' code in the Orange Book. What does this indicate?

• a.Available data are insufficient to establish therapeutic equivalence✓
• b.The product has been withdrawn from the market for safety reasons
• c.The product is fully bioequivalent to the reference listed drug
• d.The product is available only as a brand name

Codes beginning with B indicate products the FDA does not consider therapeutically equivalent, and BX specifically means the data are insufficient to determine equivalence, so automatic substitution is not appropriate. AB is the code for demonstrated equivalence, and market withdrawal is handled through separate FDA actions, not the equivalence code.FDA

Which medication is generally considered a narrow-therapeutic-index drug for which switching between manufacturers warrants extra caution and monitoring?

• a.Ibuprofen
• b.Loratadine
• c.Amoxicillin
• d.Warfarin✓

Warfarin has a narrow therapeutic index, so small changes in blood level can cause bleeding or clotting and INR monitoring is needed after any product change. Amoxicillin, ibuprofen, and loratadine have wide margins between effective and toxic doses and are not narrow-therapeutic-index agents.

Montelukast is most commonly prescribed for which condition?

• a.Gastroesophageal reflux disease
• b.Asthma maintenance and allergic rhinitis✓
• c.Relief of an acute asthma attack
• d.Chronic obstructive pulmonary disease

Montelukast is a leukotriene receptor antagonist taken on a schedule for long-term asthma control and for allergic rhinitis. It has no bronchodilator activity, so it cannot relieve an attack that is already under way; that calls for a short-acting beta agonist such as albuterol. It is not an approved treatment for chronic obstructive pulmonary disease, and reflux is treated with acid suppressants such as omeprazole.

Tamsulosin is indicated primarily for the treatment of:

• a.Benign prostatic hyperplasia✓
• b.Erectile dysfunction
• c.Overactive bladder
• d.Urinary tract infection

Tamsulosin is an alpha-1 blocker that relaxes smooth muscle in the prostate and bladder neck, improving urine flow in benign prostatic hyperplasia. Overactive bladder is treated with antimuscarinics such as oxybutynin, erectile dysfunction with agents such as sildenafil, and urinary infections with antibiotics.

A patient is discharged after coronary stent placement with a prescription for clopidogrel (Plavix). What is the purpose of this medication?

• a.To slow the heart rate and lower blood pressure
• b.To lower LDL cholesterol and blood lipids
• c.To inhibit platelet aggregation and prevent clot formation✓
• d.To control blood glucose in type 2 diabetes

Clopidogrel is an antiplatelet agent that blocks the P2Y12 ADP receptor, reducing the risk of stent thrombosis, myocardial infarction, and stroke. Lowering LDL cholesterol and blood lipids is the role of statins such as atorvastatin, controlling blood glucose in type 2 diabetes belongs to agents such as metformin, and slowing the heart rate while lowering blood pressure is what beta blockers such as metoprolol do.

A patient newly diagnosed with hypothyroidism presents a prescription. Which medication is expected?

• a.Methimazole
• b.Prednisone
• c.Metformin
• d.Levothyroxine✓

Hypothyroidism is treated by replacing the missing hormone with levothyroxine. Methimazole suppresses thyroid hormone production and is used for hyperthyroidism, metformin treats type 2 diabetes, and prednisone is a corticosteroid used for inflammation.

Which of the following products should NOT be crushed before administration?

• a.Immediate-release lisinopril tablet
• b.Chewable montelukast tablet
• c.Enteric-coated aspirin tablet✓
• d.Scored metoprolol tartrate tablet

The enteric coating on aspirin is designed to keep the tablet intact until it passes the stomach, so crushing destroys that protection and increases gastric irritation. Immediate-release and scored tablets may generally be split or crushed, and chewable tablets are meant to be broken down in the mouth.

How should a sublingual nitroglycerin tablet be administered during an episode of chest pain?

• a.Dissolved in a glass of juice and swallowed with food
• b.Chewed thoroughly and swallowed with a sip of water
• c.Placed under the tongue and allowed to dissolve without swallowing✓
• d.Swallowed whole with a full glass of water and food

Sublingual tablets dissolve under the tongue so the drug is absorbed directly into the bloodstream through the oral mucosa, giving rapid onset and bypassing first-pass liver metabolism. Chewing and swallowing the tablet, washing it down with water, or dissolving it in juice all send the dose through the digestive tract, where first-pass metabolism removes most of it before it can relieve chest pain.

A patient is dispensed otic drops for an ear infection. Which counseling point is correct?

• a.The drops should be diluted with water before each use
• b.The drops must be refrigerated and instilled cold
• c.The drops may be used in either the ear or the eye if needed
• d.The drops are for the ear only and must never be instilled in the eye✓

Otic products are not manufactured to be sterile and isotonic for ocular use, so instilling them in the eye can cause pain and injury; ophthalmic drops, by contrast, may be used in the ear. Otic drops are normally stored at room temperature, warmed slightly in the hand if cold, and are never diluted by the patient.

Insulin glargine (Lantus) is administered by which route?

• a.Intramuscular
• b.Intradermal
• c.Intravenous
• d.Subcutaneous✓

Insulin glargine is injected into subcutaneous fat, where its slow, steady absorption produces basal coverage over about 24 hours. Intravenous administration would produce an immediate, unpredictable drop in glucose and is reserved for regular insulin, while intramuscular and intradermal routes are not used for insulin therapy.

A patient taking lisinopril reports a persistent dry, tickling cough that started a few weeks after beginning therapy. What is the most likely explanation?

• a.The cough indicates an allergic reaction requiring epinephrine
• b.Dry cough is a recognized ACE inhibitor effect related to bradykinin accumulation✓
• c.Lisinopril does not cause cough, so the symptom is unrelated
• d.The cough is a sign that the dose is too low

ACE inhibitors block breakdown of bradykinin in the respiratory tract, and the resulting dry, nonproductive cough is a well-known reason patients are switched to an ARB such as losartan. It is not an anaphylactic reaction, and the cough is dose-independent rather than a sign of underdosing.

Which symptom should a patient starting atorvastatin be told to report promptly to the prescriber?

• a.A dry, persistent cough at night
• b.Unexplained muscle pain, tenderness, or weakness✓
• c.Swelling of the ankles and feet each evening
• d.An unusually slow pulse noticed on waking

Statins can cause myopathy and, rarely, rhabdomyolysis, so new unexplained muscle pain, tenderness, or weakness needs prompt evaluation and possible creatine kinase testing. A dry persistent cough is the classic adverse effect of ACE inhibitors such as lisinopril, ankle and foot swelling is characteristic of dihydropyridine calcium channel blockers such as amlodipine, and an unusually slow pulse points toward a beta blocker such as metoprolol — none of the three is a characteristic statin effect.

A patient is starting a course of metronidazole. Which counseling point is most important?

• a.Avoid alcohol during therapy and for several days after the last dose✓
• b.Double the next dose if a dose is missed to stay on schedule
• c.Expect the urine to turn bright blue for a few days
• d.Take each dose on a completely empty stomach with water

Metronidazole combined with alcohol can produce a disulfiram-like reaction with flushing, nausea, vomiting, and palpitations, so alcohol is avoided during therapy and for a few days afterward. The drug may be taken with food to reduce stomach upset, it can darken urine to a reddish-brown rather than turning it blue, and doubling up after a missed dose raises the risk of adverse effects instead of catching the schedule back up.

A patient stabilized on warfarin asks whether it is acceptable to take ibuprofen for back pain. What is the appropriate response?

• a.Ibuprofen raises bleeding risk with warfarin; the patient should check with the prescriber first✓
• b.Ibuprofen may be taken only if the warfarin dose is skipped that day
• c.Ibuprofen decreases warfarin's effect, so the warfarin dose must be doubled
• d.Ibuprofen has no interaction with warfarin and may be taken freely

NSAIDs such as ibuprofen irritate the gastrointestinal lining and inhibit platelet function, which adds to warfarin's anticoagulant effect and increases bleeding risk, so the prescriber should be consulted and acetaminophen is often preferred. The interaction increases rather than decreases bleeding risk, and patients should never adjust or skip warfarin doses on their own.

How should unopened vials of insulin glargine be stored in the pharmacy?

• a.In the refrigerator at 2-8 °C, protected from freezing✓
• b.In a warming cabinet held at 30-35 °C
• c.At room temperature only, discarded after 7 days
• d.In the freezer at -10 °C until needed

Unopened insulin is stored in the refrigerator at 2-8 °C, where it remains stable until the manufacturer's expiration date. Freezing denatures insulin and makes the vial unusable, storage in a warming cabinet shortens potency well before the labeled expiration, and the room-temperature limit that does exist applies to a vial already in use, not to unopened stock in the pharmacy.

'Controlled room temperature' on a manufacturer's storage label corresponds to which temperature range?

• a.8-15 °C
• b.15-20 °C
• c.20-25 °C✓
• d.2-8 °C

Controlled room temperature is defined as 20-25 °C, with brief excursions permitted between 15 and 30 °C. The 2-8 °C range describes refrigeration, while 8-15 °C corresponds to a cool storage area and 15-20 °C falls below the controlled room temperature range.USP

What is the correct storage instruction for sublingual nitroglycerin tablets?

• a.Keep them in the original glass container, tightly closed and protected from light and moisture✓
• b.Keep the bottle open on the bathroom shelf so it can be reached quickly
• c.Store the bottle in the refrigerator at 2-8 °C to keep it potent longer
• d.Transfer the tablets to a weekly pill organizer so doses are not missed

Nitroglycerin is volatile and moisture sensitive, so it must remain in its original tightly closed amber glass container to preserve potency. A pill organizer and an open bottle both expose the tablets to air and to the humidity of a bathroom, and refrigeration adds condensation rather than stability. Any of these can leave the patient holding tablets that no longer work during chest pain.

Latanoprost ophthalmic solution is dispensed to a patient with glaucoma. What are the correct storage directions?

• a.Refrigerate the unopened bottle at 2-8 °C; once opened it may be kept at room temperature for up to 6 weeks✓
• b.Keep the bottle in direct sunlight, since light exposure keeps the solution clear
• c.Keep the bottle frozen and let it thaw at room temperature before the first dose is given
• d.Store it at room temperature indefinitely, with no beyond-use limit after opening

Unopened latanoprost requires refrigeration, and after the bottle is opened it may be stored at room temperature for the period stated in the manufacturer's labeling. Light exposure degrades the drug rather than keeping the solution clear, freezing is not an appropriate way to store an ophthalmic solution, and an opened bottle does carry a limited in-use period rather than none at all.

A prescription is entered for hydroxyzine 25 mg. Which medication is most likely to be selected in error because of a classic look-alike/sound-alike name pair?

• a.Hydralazine✓
• b.Hydrocodone
• c.Hydrocortisone
• d.Hydrochlorothiazide

Hydroxyzine and hydralazine are a well-documented look-alike/sound-alike pair; one is an antihistamine and the other an antihypertensive vasodilator, so a mix-up can cause serious harm. Hydrocortisone is a corticosteroid, hydrochlorothiazide a thiazide diuretic, and hydrocodone an opioid, none of which form this classic confusion pair.

Which of the following is classified as a high-alert medication?

• a.Loratadine 10 mg tablets
• b.Concentrated potassium chloride injection✓
• c.Acetaminophen 325 mg tablets
• d.Docusate sodium 100 mg capsules

Concentrated potassium chloride for injection is a high-alert medication because an undiluted dose can cause fatal cardiac arrhythmia; other high-alert classes include insulin, anticoagulants, opioids, and neuromuscular blockers. Loratadine, acetaminophen at standard strength, and docusate carry a much lower risk of catastrophic harm when an error occurs.

Product labels print certain drug names as buPROPion and busPIRone. What is the purpose of this formatting?

• a.Tall man lettering highlights the differing letters to reduce name selection errors✓
• b.Capital letters mark the product as requiring refrigeration
• c.The uppercase portion shows the manufacturer's abbreviation
• d.Capital letters indicate the drug is a controlled substance

Tall man lettering capitalizes the dissimilar portion of look-alike drug names so staff notice the difference during selection and dispensing. It carries no meaning about controlled substance status, storage requirements, or the manufacturer.

A prescription is written for clonidine to treat hypertension. Which sound-alike medication could be dispensed in error?

• a.Colchicine
• b.Clopidogrel
• c.Clonazepam✓
• d.Clindamycin

Clonidine and clonazepam are a recognized sound-alike pair; clonazepam is a benzodiazepine, so dispensing it instead of an antihypertensive could cause sedation and leave blood pressure untreated. Clopidogrel is an antiplatelet drug, clindamycin an antibiotic, and colchicine a gout agent, and none of these names is close enough to be the classic confusion partner.

A prescription reads: amoxicillin 400 mg/5 mL suspension, give 200 mg by mouth twice daily. How many mL should be given per dose?

• a.5 mL
• b.10 mL
• c.2.5 mL✓
• d.1.25 mL

Since 400 mg is contained in 5 mL, 200 mg is half that amount, or 2.5 mL per dose. The 5 mL volume would deliver 400 mg, 10 mL would deliver 800 mg, and 1.25 mL would supply only 100 mg.

An insulin product is labeled 100 units/mL. A patient is instructed to inject 18 units. What volume corresponds to this dose?

• a.0.9 mL
• b.1.8 mL
• c.0.018 mL
• d.0.18 mL✓

At a concentration of 100 units/mL, each unit equals 0.01 mL, so 18 units equals 0.18 mL. A volume of 1.8 mL would contain 180 units, 0.9 mL would contain 90 units, and 0.018 mL would contain only 1.8 units.

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

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 high abuse potential and no currently accepted medical use in the United States, so they cannot be prescribed.✓
• b.They may be dispensed on a written prescription, but that prescription may never be refilled.
• c.They have a low potential for abuse and may be sold over the counter without a prescription.
• d.They may be dispensed with up to 5 refills within 6 months of the date it was written.

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 at all. A written prescription that may not be refilled describes Schedule II, and up to 5 refills within 6 months of the date written describes Schedules III and IV. Over-the-counter sale is impossible for any controlled substance in Schedule I, whose lawful handling is 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.Registering a new pharmacy with the DEA for the first time
• b.Reporting a significant theft or loss of controlled substances
• c.Documenting the destruction of expired controlled substances on site
• d.Ordering or transferring Schedule II controlled substances between DEA registrants✓

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, which must still be retained. A significant theft or loss is reported on Form 106, destruction is documented on Form 41, and an initial pharmacy registration is made on 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 106
• b.DEA Form 224
• 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.Notify the DEA and submit DEA Form 106 for the theft or significant loss✓
• b.Submit a new DEA Form 222 to replace the lost stock
• c.Complete DEA Form 41 to document the missing product
• d.Record the shortage on the next biennial inventory only

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

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.Up to 3 refills within 12 months of the date written
• c.Up to 5 refills within 6 months of the date written✓
• d.Unlimited refills for 12 months from 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 IV
• b.Class II
• c.Class I✓
• d.Class III

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 manufacturer's voluntary copay assistance program that lowers the amount a commercially insured patient pays for a specialty drug
• b.A USP compounding standard that sets the beyond-use dates and the sterile air quality requirements that apply to compounded preparations
• c.An FDA-required safety program that may mandate prescriber certification, patient enrollment, pharmacy certification, or laboratory monitoring before a drug is dispensed✓
• d.A DEA quota program that limits how much of a controlled substance a pharmacy may order and keep in stock in a given month

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. Beyond-use dating and air quality standards for compounding come from USP, quotas for controlled substances are set by the DEA at the manufacturing level rather than per pharmacy, and manufacturer copay assistance carries no regulatory safety role at all.FDA REMS (FDAAA 2007)

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

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

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>