PTCB Pharmacy Technician (PTCE) — All Questions

Which of these pairs of oral antidiabetic agents appears on the ISMP List of Confused Drug Names?

• a.metformin and insulin glargine
• b.glipiZIDE and glyBURIDE✓
• c.acarbose and pioglitazone
• d.sitagliptin and empagliflozin

glipiZIDE and glyBURIDE are listed together on the ISMP List of Confused Drug Names and are written with tall man letters for that reason. The other three pairings are not confused-name entries; they are simply different drug classes that happen to treat the same condition.

Why are HumaLOG and HumuLIN printed with tall man letters on shelf labels?

• a.The two products contain the same insulin at different strengths.
• b.Tall man letters identify products that require a prescription.
• c.Tall man letters mark every product that must be refrigerated.
• d.They are a look-alike name pair on the ISMP list of confused drug names.✓

HumaLOG and HumuLIN are listed as a confused-name pair, and the tall man capitals highlight the letters that differ so the eye is not misled by the shared beginning. They are not the same insulin, and tall man lettering has nothing to do with refrigeration or with prescription status.

A prescription for traMADol is being filled. Which drug does the ISMP List of Confused Drug Names pair with it?

• a.triamterene
• b.tranexamic acid
• c.traZODone✓
• d.trandolapril

traMADol and traZODone are a documented confused-name pair on the ISMP list, which is why both carry tall man letters. Tranexamic acid, triamterene and trandolapril begin with similar letters but are not the pairing ISMP records for tramadol.

A pharmacy stocks both predniSONE 20 mg tablets and prednisoLONE 15 mg/5 mL solution. What does the shared listing of these two names on the ISMP confused-name list tell the technician?

• a.The two products are interchangeable at equal milligram doses in adults.
• b.A documented look-alike pair; match name, strength and form.✓
• c.The pair may be stored together because the strengths differ.
• d.Only the solution needs to be kept behind the counter.

predniSONE and prednisoLONE are listed as a confused pair, so the technician matches the complete name, strength and dosage form rather than the first seven letters. They are distinct drugs and not interchangeable milligram for milligram, neither requires behind-the-counter placement on that account, and differing strengths do not make co-location safe for a confusable pair.

SITagliptin and SUMAtriptan are printed with tall man letters. What risk does that formatting address?

• a.Both drugs are high-alert medications requiring a double check.
• b.Both require a medication guide at every fill.
• c.Both must be stored in a locked cabinet.
• d.They are a confused-name pair on the ISMP list, so the capitals separate them.✓

SITagliptin and SUMAtriptan appear together on the ISMP List of Confused Drug Names, and the tall man capitals draw attention to the syllables that differ. Tall man lettering is not a marker of high-alert status, of controlled-substance storage, or of medication guide requirements; those are separate designations with their own sources.

According to CDC vaccine storage guidance, what temperature range should a refrigerator holding vaccines maintain?

• a.0 to 4 degrees Celsius (32 to 39 degrees Fahrenheit)
• b.2 to 15 degrees Celsius (36 to 59 degrees Fahrenheit)
• c.2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit)✓
• d.8 to 15 degrees Celsius (46 to 59 degrees Fahrenheit)

CDC states that refrigerators should maintain temperatures between 2 and 8 degrees Celsius, which is 36 to 46 degrees Fahrenheit. A range starting at 0 degrees risks freezing, and the 2 to 15 and 8 to 15 ranges describe cool storage rather than the refrigerated range CDC specifies for vaccines.

A pharmacy stores a frozen vaccine. Which freezer temperature range does CDC specify?

• a.-50 to -15 degrees Celsius (-58 to +5 degrees Fahrenheit)✓
• b.-10 to 0 degrees Celsius (14 to 32 degrees Fahrenheit)
• c.-25 to -10 degrees Celsius (-13 to 14 degrees Fahrenheit)
• d.-80 to -60 degrees Celsius (-112 to -76 degrees Fahrenheit)

CDC states that freezers should maintain temperatures between -50 and -15 degrees Celsius, or -58 to +5 degrees Fahrenheit. The -10 to 0 range is too warm to be a vaccine freezer, -25 to -10 is a general compendial freezer definition rather than the CDC vaccine range, and -80 to -60 describes ultra-cold storage used for particular products.

A pharmacy manager proposes storing influenza vaccine in a small dormitory-style refrigerator/freezer with a single outer door. What does CDC guidance say?

• a.It is acceptable for temporary storage of a single day's supply of vaccine.
• b.Vaccine must never be stored in such a combined unit.✓
• c.It is acceptable provided the freezer compartment is left empty.
• d.It is acceptable if a digital data logger is placed inside.

CDC states plainly that vaccine should never be stored in a dormitory-style or bar-style combined unit, and that such units pose a significant risk of freezing vaccines even when used for temporary storage. Adding a data logger records the problem but does not prevent it, and emptying the freezer compartment does not change the evaporator plate that causes the freezing.

A pharmacy's cleanroom keeps concentrated disinfectants and other corrosive chemicals. What does the OSHA medical services and first aid standard require?

• a.A written spill plan posted at the door.
• b.A monthly air sampling report filed with the local OSHA area office.
• c.A respirator for every employee on the shift.
• d.Eye and body flushing in the work area.✓

29 CFR 1910.151, paragraph (c), states that where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing shall be provided within the work area for immediate emergency use. A posted spill plan, respirators for all staff and monthly air sampling reports are not what this paragraph requires.29 CFR 1910.151(c)

Under the OSHA Bloodborne Pathogens Standard, what must a sharps injury log contain at a minimum?

• a.The injured employee's name, home address and physician.
• b.The type and brand of device, the work area, and how the incident occurred.✓
• c.The dollar cost of treatment and the days of work lost.
• d.A photograph of the device and a copy of the employee's vaccination record.

The standard lists exactly three minimum items: the type and brand of device involved in the incident, the department or work area where the exposure incident occurred, and an explanation of how the incident occurred. It also requires that the log be kept in a way that protects the injured employee's confidentiality, which rules out recording the employee's identifying details.29 CFR 1910.1030(h)(5)

A sealed stock bottle is opened and found to contain tablets of two different shapes and colours. Where should the pharmacy report this?

• a.to FDA MedWatch, which receives product quality problems as well as adverse events✓
• b.to VAERS, which receives all reports about marketed medicines
• c.to the DEA on Form 106
• d.to the state board of pharmacy only, since it is a manufacturing matter

MedWatch is FDA's safety reporting program for prescription and over-the-counter medicines and takes product quality problems as well as adverse events. VAERS is restricted to vaccine adverse events, DEA Form 106 records theft or significant loss of controlled substances, and the state board is not the agency that collects national product quality signals.

An electronic prescription for methotrexate for rheumatoid arthritis arrives with the directions 'take 2.5 mg by mouth daily'. What should the technician do?

• a.Enter it as written, because the prescriber chose the directions.
• b.Change the directions to once weekly before entering the prescription.
• c.Dispense a seven-day supply and ask the patient to confirm with the prescriber.
• d.Stop and give the prescription to the pharmacist to verify the frequency with the prescriber.✓

Daily rather than weekly methotrexate for rheumatoid arthritis is a well-known and potentially fatal error pattern, so the prescription is escalated to the pharmacist, who contacts the prescriber. A technician may neither enter a suspect frequency unchanged nor rewrite directions on their own authority, and dispensing part of it while the patient makes the call leaves the patient holding an unverified dose.

A prescriber's office telephones a new prescription and the pharmacist takes it. Which step most reliably catches a transcription error during that call?

• a.Asking the caller to spell only the patient's last name.
• b.Reading the complete order back to the caller, including strength, dose and frequency.✓
• c.Entering the order quickly so the caller is not kept waiting.
• d.Writing the order down and comparing it to the patient's last refill.

A read-back of the complete order gives the caller the chance to hear and correct a misheard drug name, strength or frequency while still on the line. Spelling only the patient's name does not check the drug, speed increases the chance of mishearing, and comparing with a previous refill cannot validate a therapy the patient has never had.

A patient returns to the counter saying this month's tablets look different from last month's. What is the appropriate first step?

• a.Compare the NDC and manufacturer with the previous fill, then get the pharmacist.✓
• b.Reassure the patient that all generics look the same and complete the sale.
• c.Replace the tablets with the previous manufacturer's product without checking anything.
• d.Tell the patient to take the new tablets for a week and call back if anything happens.

Checking the NDC and manufacturer answers the question with a record rather than a reassurance, and if the drug or strength is wrong the error is caught before the patient leaves; the pharmacist then explains a legitimate manufacturer change or investigates a real error. Generic products from different makers often do look different, swapping stock blindly hides rather than resolves the question, and telling the patient to wait a week risks a week of a wrong medicine.

What should the technician leave with a completed prescription so the pharmacist can perform a meaningful final verification?

• a.The stock bottle alone, because its NDC already identifies everything that matters.
• b.Only the filled container, since the label is attached to it.
• c.The filled container and the patient's insurance card.
• d.The prescription, label, filled vial and stock bottle.✓

The pharmacist's final check compares four things: what was ordered, what the label says, what is in the vial and what it was counted from, so all four have to be present. A vial by itself cannot be checked against the order, an insurance card says nothing about the product, and a stock bottle alone shows what was on the shelf but not what was actually dispensed or directed.

A patient profile records an allergy to 'sulfa'. Which new prescription should be routed to the pharmacist before it is filled?

• a.metformin 500 mg tablets
• b.amoxicillin 500 mg capsules
• c.sulfamethoxazole/trimethoprim DS tablets✓
• d.azithromycin 250 mg tablets (Z-Pak)

Sulfamethoxazole is a sulfonamide antimicrobial, exactly the class a documented sulfa allergy refers to, so the pharmacist assesses it before the prescription is filled. Metformin is a biguanide, amoxicillin is a penicillin and azithromycin is a macrolide; none of the three belongs to the sulfonamide class.

A prescription reads: take 1 tablet by mouth every morning and 2 tablets by mouth every evening. Ninety tablets are dispensed. What is the day supply?

• a.45 days
• b.30 days✓
• c.60 days
• d.22 days

The patient takes 1 + 2 = 3 tablets a day, so 90 tablets divided by 3 tablets per day equals 30 days. The 45-day answer counts only two tablets a day, 60 days counts only one and a half, and 22 days would require four tablets a day.

A sig reads: take 2 teaspoonfuls by mouth three times daily for 7 days. Using 5 mL per teaspoonful, what quantity should be dispensed?

• a.70 mL
• b.210 mL✓
• c.105 mL
• d.420 mL

Two teaspoonfuls is 10 mL, three times daily is 30 mL a day, and 30 mL x 7 days = 210 mL. The 70 mL answer uses one dose a day, 105 mL treats the dose as one teaspoonful, and 420 mL doubles the correct number of days.

A technician blends 100 g of a 1% ointment with 300 g of a 5% ointment. What is the percentage strength of the finished 400 g mixture?

• a.6%
• b.3%
• c.2.5%
• d.4%✓

The 100 g of 1% ointment contributes 1 g of drug and the 300 g of 5% contributes 15 g, so the mixture holds 16 g of drug in 400 g, and 16 divided by 400 is 0.04, or 4%. The 3% answer averages the two percentages without weighting them, 2.5% is the simple midpoint of 1 and 5 halved again, and 6% is higher than either starting ointment, which is impossible when the two are blended.

A 1 g vial of powdered antibiotic is to be reconstituted to a final concentration of 100 mg/mL. The powder occupies 0.7 mL. How much diluent should be added?

• a.10 mL
• b.0.7 mL
• c.10.7 mL
• d.9.3 mL✓

A 1 g (1,000 mg) vial at 100 mg/mL needs a final volume of 1,000 divided by 100, which is 10 mL. The powder already occupies 0.7 mL, so 10 - 0.7 = 9.3 mL of diluent is added. Adding 10 mL would give a final volume of 10.7 mL and a weaker solution, 0.7 mL is only the powder volume, and 10.7 mL ignores displacement in the wrong direction.

A bag contains 25,000 units of heparin in 500 mL of diluent and the pump is set at 14 mL/hr. How many units per hour is the patient receiving?

• a.700 units/hr✓
• b.350 units/hr
• c.1,400 units/hr
• d.500 units/hr

The concentration is 25,000 units divided by 500 mL, which is 50 units/mL, and 50 units/mL x 14 mL/hr = 700 units/hr. The 350 answer uses 25 units/mL, 1,400 doubles the rate, and 500 simply repeats the bag volume as if it were a dose.

A continuous infusion runs at 125 mL/hr for a full 24 hours and is supplied in 1,000 mL bags. How many bags are needed for the day?

• a.2 bags
• b.2.5 bags
• c.4 bags
• d.3 bags✓

125 mL/hr x 24 hr = 3,000 mL, which is exactly three 1,000 mL bags. Two bags would run out after 16 hours, a half bag cannot be hung as a separate unit, and four bags would supply 4,000 mL, a full litre more than the order calls for.

A compounding record calls for capsules containing 250 mg of active drug each. How many capsules can be filled from 15 g of the drug?

• a.15 capsules
• b.60 capsules✓
• c.150 capsules
• d.40 capsules

15 g is 15,000 mg, and 15,000 divided by 250 mg per capsule equals 60 capsules. The 15 answer confuses grams with capsules, 40 would apply to a 375 mg capsule, and 150 would apply to a 100 mg capsule.

A prescriber orders 62.5 mg once daily for 30 days. The pharmacy stocks 25 mg scored tablets. What quantity should be dispensed?

• a.90 tablets
• b.60 tablets
• c.75 tablets✓
• d.30 tablets

62.5 mg divided by 25 mg per tablet is 2.5 tablets per dose, and 2.5 x 30 days = 75 tablets. The 60-tablet answer assumes two tablets a day, 90 assumes three, and 30 assumes one.

A pharmacy buys a product for $60.00 and sells it for $80.00. What is the gross margin expressed as a percentage of the selling price?

• a.25%✓
• b.33.3%
• c.20%
• d.80%

Gross profit is $80.00 - $60.00 = $20.00, and as a share of the selling price that is 20 divided by 80, or 25%. The 20% answer confuses the dollar profit with a percentage, 33.3% is the markup on cost rather than the margin on price, and 80% simply repeats the selling price.

A prescription costs the pharmacy $14.60 to acquire and $3.20 to dispense. The plan reimburses $21.40 in total. What is the net profit on this prescription?

• a.$3.60✓
• b.$6.80
• c.$17.80
• d.$10.00

Total cost is $14.60 + $3.20 = $17.80, and $21.40 - $17.80 = $3.60 net profit. The $6.80 answer is the gross profit before the dispensing cost is subtracted, $17.80 is the total cost itself, and $10.00 corresponds to no step in the calculation.

A fast-moving product has a par level of 6 bottles. The shelf holds 2 bottles and 1 more is already on order from the wholesaler. How many bottles should be added to today's order?

• a.6 bottles
• b.5 bottles
• c.3 bottles✓
• d.2 bottles

The par level counts everything the pharmacy will have on hand, so 6 - 2 on the shelf - 1 already on order = 3 bottles. Ordering 6 ignores both the stock and the pending order, 5 counts the shelf stock but forgets the order in transit, and 2 would leave the pharmacy one bottle short of par.

A prescription calls for 8 fluid ounces of a suspension. Using 30 mL per fluid ounce, how many millilitres should be dispensed?

• a.240 mL (8 x 30 mL)✓
• b.120 mL
• c.180 mL
• d.480 mL

8 fluid ounces x 30 mL per ounce = 240 mL. The 120 mL answer uses 15 mL per ounce, 180 mL would be 6 ounces, and 480 mL doubles the requested volume.

How many milligrams of drug are contained in 2 mL of a 1:200 solution?

• a.2 mg
• b.5 mg
• c.20 mg
• d.10 mg✓

A 1:200 solution holds 1 g in 200 mL, which is 1,000 mg in 200 mL, or 5 mg/mL; 2 mL therefore contains 10 mg. The 2 mg answer repeats the volume, 5 mg is the amount in a single millilitre, and 20 mg would require a 1:100 solution.

A cash-paying customer presents a discount card that takes 35% off the pharmacy's usual price of $84.00. What does the customer pay?

• a.$29.40
• b.$60.90
• c.$49.00
• d.$54.60✓

The discount is $84.00 x 0.35 = $29.40, so the customer pays $84.00 - $29.40 = $54.60. The $29.40 answer is the discount itself rather than the price paid, $49.00 would be a 41.7% discount, and $60.90 corresponds to a 27.5% discount.

An order is entered from the sig 'i supp PR qhs prn constipation'. Which label directions are correct?

• a.Insert one suppository rectally at bedtime as needed.✓
• b.Insert one suppository vaginally every hour as needed for constipation.
• c.Insert one suppository rectally every morning as needed for constipation.
• d.Take one tablet by mouth at bedtime as needed for constipation.

PR is per rectum, qhs is at bedtime and prn is as needed, so one suppository is inserted rectally at bedtime as needed. An oral tablet is the wrong route and form, PV would be the vaginal route, and qhs means at bedtime rather than every hour or every morning.

An eye drop is entered from the sig 'i gtt OD bid'. What should the label tell the patient to do?

• a.Instill 1 drop into the right eye twice daily.✓
• b.Instill 1 drop into the left eye twice daily.
• c.Instill 1 drop into each eye once daily.
• d.Instill 1 drop into the right ear twice daily.

OD is oculus dexter, the right eye, gtt is a drop and bid is twice daily. OS would be the left eye, OU would be each eye, and AD would be the right ear. ISMP asks that these abbreviations be spelled out precisely because OD and AD have been read for one another.

Nitroglycerin is entered from the sig 'i tab SL q5min prn chest pain, max 3 doses'. Which label directions are correct?

• a.Swallow one tablet every 5 minutes as needed for chest pain, up to 3 tablets.
• b.Place one tablet under the tongue every 5 minutes as needed for chest pain, no more than 3 doses.✓
• c.Place one tablet under the tongue every 5 hours as needed for chest pain, up to 3 tablets.
• d.Chew one tablet every 5 minutes as needed for chest pain, with no maximum.

SL is sublingual, so the tablet is placed under the tongue, q5min is every five minutes, and the maximum of three doses has to be carried onto the label. Swallowing or chewing changes the route, every 5 hours misreads the frequency, and dropping the maximum removes the limit that keeps the patient from taking more than the prescriber allowed.

A claim is rejected with the message 'M/I cardholder ID'. What does that reject mean and how is it resolved?

• a.The member ID is missing or invalid; re-enter it.✓
• b.The drug is not covered; request a formulary alternative.
• c.The prescriber is not enrolled; obtain a new prescription.
• d.The quantity exceeds the plan's limit; reduce the day supply and re-submit.

M/I stands for missing or invalid, so the cardholder ID transmitted does not match the plan's records and the number is checked against the card and re-entered. A non-covered drug, an unenrolled prescriber and a quantity limit each produce their own distinct reject messages.

A patient has coverage under two prescription plans. How should the claim be processed?

• a.Split the quantity and bill half to each plan.
• b.Bill primary first, then the secondary plan.✓
• c.Bill both plans for the full amount at the same time.
• d.Bill whichever plan leaves the lower copay and ignore the other one entirely.

Coordination of benefits means the primary plan adjudicates first and the balance it leaves is then submitted to the secondary plan. Splitting the quantity misrepresents what was dispensed, choosing by copay ignores the order of liability the plans have agreed, and billing both in full at once would claim the same cost twice.

An electronic prescription arrives with a quantity of 30 tablets but directions that read 'take 1 tablet by mouth daily for 90 days'. What should the technician do?

• a.Dispense 30 tablets and enter a 90-day supply on the claim.
• b.Hold it for the pharmacist to resolve with the prescriber.✓
• c.Dispense 90 tablets, because the written directions state the longer treatment period.
• d.Enter whichever figure the insurance plan will pay for.

The quantity and the days supply contradict each other, so the prescription is not filled until the prescriber clarifies which is intended; the pharmacist makes that contact. Entering a 90-day supply for 30 tablets falsifies the claim, dispensing 90 tablets exceeds the written quantity, and choosing by what the plan will pay lets the claim rather than the prescriber decide the therapy.

A patient brings in a prescription for a product the pharmacy does not keep in stock. What is the appropriate handling?

• a.Tell the patient when the product can be ordered in, and offer to transfer the prescription.✓
• b.Return the prescription and tell the patient to look elsewhere.
• c.Substitute a similar product from another class and tell the patient afterwards.
• d.Dispense a partial quantity of a different strength to cover the gap.

The patient needs a realistic answer about timing and a choice, so the technician gives the expected arrival and offers a transfer if waiting is not workable. Substituting across drug classes is a prescribing decision no one in the pharmacy may make unilaterally, simply returning the prescription abandons the patient, and dispensing a different strength changes the dose without authorisation.

Federal regulation states that a controlled substance prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Where does the pharmacist stand in that rule?

• a.The rule binds only the prescriber; the pharmacist fills what is written.
• b.The pharmacist is responsible only if the prescription is for a Schedule II drug.
• c.A corresponding responsibility rests with the pharmacist who fills the prescription.✓
• d.Responsibility passes to the pharmacist only after the patient has taken the medicine.

21 CFR 1306.04(a) places responsibility for proper prescribing and dispensing on the prescriber 'but a corresponding responsibility rests with the pharmacist who fills the prescription', and a person knowingly filling a purported prescription is subject to the same penalties. The rule is not limited to Schedule II, it does not spare the pharmacist, and it attaches at the moment of filling rather than at administration.21 CFR 1306.04

Which item does federal regulation require on the face of every controlled substance prescription?

• a.the pharmacy's NPI number
• b.the patient's date of birth
• c.the patient's insurance identification number
• d.the full name and address of the patient✓

21 CFR 1306.05(a) requires the date of issue, the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner. Date of birth is commonly required by state law or plan rules but is not on that federal list, and an insurance number and a pharmacy NPI have nothing to do with the validity of the prescription.21 CFR 1306.05

Under federal regulation, who may fill a prescription for a controlled substance?

• a.any pharmacy employee working under a pharmacist's supervision
• b.a certified pharmacy technician who has completed controlled substance training
• c.a pharmacist acting in the usual course of professional practice at a registered pharmacy✓
• d.the pharmacy's designated power of attorney for DEA Form 222

21 CFR 1306.06 states that a controlled substance prescription may only be filled by a pharmacist acting in the usual course of professional practice and either registered individually or employed in a registered pharmacy, central fill pharmacy or institutional practitioner. Supervision does not transfer that authority to other staff, technician certification does not create it, and a power of attorney under Part 1305 covers ordering Schedule I and II substances, not dispensing to patients.21 CFR 1306.06

A prescriber wants a patient to have up to a 90-day supply of a Schedule II medication. What do federal rules permit?

• a.A single prescription may be written with two refills.
• b.A 90-day quantity may be dispensed and the pharmacy holds part of it for the patient.
• c.Multiple prescriptions may be issued on the same day, each carrying its earliest fill date.✓
• d.Nothing; a Schedule II prescription may never cover more than 30 days.

21 CFR 1306.12(a) prohibits refilling a Schedule II prescription, but 1306.12(b) allows a practitioner to issue multiple prescriptions totalling up to a 90-day supply, each carrying written instructions for the earliest fill date, provided state law permits and there is no undue risk of diversion. Refills remain prohibited, holding dispensed stock for a patient is not the mechanism the rule creates, and the regulations set no flat 30-day federal ceiling.21 CFR 1306.12

A patient asks that a written Schedule II prescription be partially filled, and the pharmacy agrees. Within what period must any remaining portion be filled?

• a.within 72 hours of the first partial filling
• b.within 30 days of the date written✓
• c.within 6 months of the date of issue
• d.there is no federal time limit once a partial fill has been recorded

21 CFR 1306.13(b)(2) requires that remaining portions of a Schedule II prescription partially filled at the request of the patient or prescriber be filled not later than 30 days after the date the prescription was written. The 72-hour limit applies to a partial fill made because the pharmacist could not supply the full quantity, six months is the Schedule III and IV limit, and the rule sets an explicit deadline rather than leaving the prescription open.21 CFR 1306.13

A patient asks a retail pharmacy to send an electronic Schedule II prescription that has not yet been dispensed to a different retail pharmacy. What do federal rules allow?

• a.The prescription may be printed and faxed to the receiving pharmacy.
• b.Electronic Schedule II prescriptions may never be transferred for any purpose.
• c.The transfer is permissible once only, must stay electronic, and is pharmacist to pharmacist.✓
• d.A technician at either pharmacy may complete the transfer if a pharmacist approves afterwards.

21 CFR 1306.08(e) permits the transfer of an electronic Schedule II to V prescription between retail pharmacies for initial dispensing on a one-time basis at the patient's request, and 1306.08(f) requires that it stay electronic and be communicated directly between two licensed pharmacists. An intermediary may not convert it to a facsimile, the transfer is not forbidden outright, and it cannot be delegated to a technician.21 CFR 1306.08

A pharmacist-in-charge wants another pharmacist at the same pharmacy to be able to sign orders for Schedule II controlled substances. What does federal regulation require?

• a.A letter to the DEA field office naming the second authorised signer.
• b.A notarised amendment to the pharmacy's DEA registration.
• c.A power of attorney executed for that individual.✓
• d.Nothing; any pharmacist on duty may sign a Form 222.

21 CFR 1305.05 lets a registrant authorise one or more individuals to sign orders for Schedule I and II substances by executing a power of attorney for each, retained in the files with the executed Forms 222 and available for inspection. A letter to the field office and an amended registration are not the mechanism, and the authority does not come automatically with being on duty.21 CFR 1305.05

How does federal regulation allow a retail pharmacy to store its Schedule II through V controlled substances?

• a.in a securely locked, substantially constructed cabinet, or dispersed through the ordinary stock✓
• b.only in a room with controlled access and an alarm reporting to a central station
• c.only in a safe or steel cabinet equivalent to a government Class V security container
• d.in any location, provided a perpetual inventory is maintained

21 CFR 1301.75(b) gives pharmacies two options: a securely locked, substantially constructed cabinet, or dispersal through the non-controlled stock in a manner that obstructs theft or diversion. The Class V security container requirement applies to a short list of substances such as carfentanil, a controlled-access alarmed room is not what the rule specifies for practitioners, and a perpetual inventory is a management tool rather than a substitute for physical security.21 CFR 1301.75

After its initial registration period, how often must a retail pharmacy renew its DEA registration?

• a.every 12 months
• b.every 36 months✓
• c.every 24 months
• d.every 60 months

21 CFR 1301.13(d) provides that for a retail pharmacy, hospital or clinic, practitioner or teaching institution, the registration expires 36 months from the initial expiration date, which is the three-year cycle pharmacies plan around. Annual renewal applies to certain manufacturer and distributor activities, and neither a two-year nor a five-year cycle appears in the regulation for a pharmacy.21 CFR 1301.13

A pharmacy that is an authorised collector maintains a controlled substance collection receptacle in the store. What does federal regulation require once a patient has deposited medication in it?

• a.Two employees must record the drug name and quantity in a logbook.
• b.The substance must not be counted, sorted or inventoried.✓
• c.The pharmacist must verify that only Schedule III to V products were deposited.
• d.The deposit must be reported to the DEA within one business day.

21 CFR 1317.75(c) states that once a substance has been deposited into a collection receptacle it shall not be counted, sorted, inventoried or otherwise individually handled, which is what makes anonymous return possible. There is no logbook of deposited drugs, ultimate users may deposit Schedule II through V products, and the two-employee requirement in 1317.75(g) applies to installing and removing the inner liner rather than to each deposit.21 CFR 1317.75

A product requires an FDA-approved Medication Guide. When must the authorised dispenser provide it to the patient?

• a.each time the product is dispensed, on new prescriptions and refills alike✓
• b.only when the patient asks for written information
• c.once a year, at the first fill of the calendar year
• d.only with the first prescription for that product

21 CFR 208.24(e) requires the authorised dispenser to provide a Medication Guide directly to each patient or the patient's agent when the product is dispensed, and 208.1(a) states that the requirement applies to new prescriptions and refill prescriptions alike. A first-fill-only, on-request-only or once-a-year practice would leave refills uncovered, and 208.26(b) adds that a Medication Guide must be given to any patient who requests it even where the prescriber has directed otherwise.21 CFR 208.24

A patient submits a written request for a copy of her own pharmacy records. Under the HIPAA Privacy Rule, how quickly must the pharmacy act on that request?

• a.within 30 days, with one 30-day extension✓
• b.within 10 business days of receipt, with no extension available under any circumstances
• c.within 60 days, with two possible extensions
• d.only after the patient's prescriber authorises the release

45 CFR 164.524(b)(2) requires the covered entity to act on a request for access no later than 30 days after receipt, and allows one extension of no more than 30 days provided the individual is given a written statement of the reason and the new date. Ten business days and sixty days are not the rule's figures, only one extension is allowed, and a patient's right of access to her own record does not depend on the prescriber's permission.45 CFR 164.524

Beyond the daily limit, federal law caps how much pseudoephedrine base a person may purchase at retail during a 30-day period. What is that cap?

• a.3.6 grams
• b.7.5 grams
• c.9 grams in any 30-day period✓
• d.24 grams

21 U.S.C. 844(a) makes it unlawful to knowingly purchase at retail more than 9 grams of ephedrine, pseudoephedrine or phenylpropanolamine base in a 30-day period, and provides that of those 9 grams no more than 7.5 may be shipped by a private or commercial carrier or the Postal Service. The 3.6 gram figure is the single-day limit in 21 CFR 1314.20, 7.5 grams alone is only the mail-order portion, and 24 grams appears nowhere in the statute.21 U.S.C. 844(a)