PTCB Pharmacy Technician (PTCE) — All Questions

A prescription sig reads: 1 tab PO qid ac & hs. Which set of patient directions is correct?

• a.Take 1 tablet by mouth every six hours around the clock with food
• b.Take 1 tablet by mouth after each meal and again at bedtime
• c.Take 1 tablet by mouth four times a day as needed for symptoms
• d.Take 1 tablet by mouth before each meal and at bedtime✓

qid is four times daily, ac is ante cibum or before meals, and hs is hora somni or at bedtime, so the four doses fall before each of the three meals and once at bedtime. Reading the doses as coming after meals swaps ac for pc, post cibum, which moves every dose to the wrong side of the meal and matters for drugs that must be taken on an empty stomach. Doses spaced every six hours around the clock would be written q6h, which detaches them from meals, and nothing in this sig makes the drug an as-needed one.

A prescription reads: hydrocortisone 1% ung, apply to the affected area bid. The shelf holds both a cream and an ointment of that drug and strength. Which product should be pulled?

• a.Either product, because a cream and an ointment of the same strength are interchangeable
• b.The ointment, because ung abbreviates unguentum✓
• c.The lotion, because ung indicates a pourable topical preparation
• d.The cream, because ung marks a water-washable topical base

ung is the abbreviation for unguentum, the Latin word for ointment, so the ointment is the dosage form the prescriber ordered. Treating the cream as equivalent is the tempting error, because both are semisolid topicals of the same drug and strength, but the base changes how the drug is delivered and how long it stays on the skin, and a change of dosage form needs the prescriber's authorisation. A cream would be written crm, and a lotion is a separate pourable dosage form altogether.

Why must the NDC transmitted on a third-party claim match the NDC on the stock bottle actually used to fill the prescription?

• a.A mismatched NDC changes the product's therapeutic equivalence rating and blocks substitution
• b.Federal law requires the dispensing label to print the same NDC that the claim carries
• c.The NDC sets the price the pharmacy paid the wholesaler
• d.The plan pays for the exact package billed and audits compare it to the stock used✓

The NDC on a claim is the pharmacy's statement of whose package, in what size, was dispensed; reimbursement is calculated from that number and an auditor reconciles it against the bottles on the shelf and the purchase invoices, so billing one manufacturer's NDC while dispensing another's produces a recoverable overpayment even when the drug is identical. The labelling answer is the closest wrong one, because the NDC often does print on the dispensing label, but that is pharmacy and state practice rather than what makes the match matter on the claim. Therapeutic equivalence ratings come from the Orange Book, and the NDC identifies a package rather than a price.

A prescriber leaves the substitution line open on a brand-name prescription that has an AB-rated generic, the patient asks for nothing in particular, and the pharmacy dispenses the generic. Which DAW code belongs on the claim?

• a.DAW 3, substitution allowed and the pharmacist selected the brand
• b.DAW 0, no product selection indicated✓
• c.DAW 2, substitution allowed but the patient requested the brand
• d.DAW 1, substitution not allowed by the prescriber

DAW 0 is the code for a claim on which nobody indicated a product selection, which is exactly what a routine generic fill is. The pharmacist-selected code is the closest wrong answer, because a pharmacist did choose the product here, but that code is reserved for the case where the pharmacist dispenses the brand although substitution was allowed. The prescriber code applies only when the prescriber blocks substitution, and the patient code only when the patient asks for the brand and pays the difference.

A prescriber wants to transmit controlled-substance prescriptions to the pharmacy electronically. Under the federal EPCS rules, what must be true of that transmission?

• a.The prescription must be followed by a signed paper copy delivered to the pharmacy within seven days
• b.The prescriber signs each prescription with two-factor authentication in a certified application✓
• c.Office staff may transmit the prescription under the prescriber's shared log-in
• d.Only Schedule III through V prescriptions may be sent electronically

Electronic prescribing of controlled substances is open to every schedule the prescriber may write, but the practitioner has to sign the record inside an application certified for the purpose, using two of the three permitted identity factors. The paper follow-up is the closest wrong answer, because an emergency oral order for a Schedule II drug really does have to be covered by a written prescription within seven days, while a compliant electronic prescription is the legal record on its own. A shared log-in defeats the whole point of the signing credential, which is personal to the prescriber and may not be delegated.21 CFR part 1311

A patient asks a second pharmacy to pick up the remaining refills on an alprazolam prescription. The two pharmacies do not share a real-time online database. What does federal law allow?

• a.The remaining refill information may be transferred one time only✓
• b.The refill information may be transferred as often as refills remain
• c.Transfer is barred for every controlled substance, whatever its schedule
• d.Transfer requires a new prescription from the prescriber

Alprazolam is a Schedule IV drug, and federal rules let the refill information on a Schedule III, IV or V prescription be transferred between pharmacies on a one-time basis. Repeated transfers are the closest wrong answer, because pharmacies that share a real-time online database may indeed transfer up to the number of refills authorised, and this pair does not qualify for that exception. A blanket ban would be right only for Schedule II, which carries no refills at all, and asking the prescriber for a new prescription is always an option but is not what the transfer rule permits.21 CFR 1306.25

A patient leaving the country for a month asks to refill a maintenance drug early, and the claim rejects as refill too soon. What is the correct step?

• a.Contact the plan and request a vacation supply override✓
• b.Change the day supply on the claim until the refill goes through
• c.Resubmit the claim each morning until it pays
• d.Sell the early refill as a cash prescription without telling the plan

Plans build a vacation or extended-travel override into their refill-too-soon edits, and the pharmacy obtains it by calling the help desk with the travel dates. The cash sale is the closest wrong answer, because a patient may legitimately choose to pay cash, but doing it silently costs the patient a benefit they are entitled to and leaves the early supply off the plan's profile. Altering the day supply to force payment is a false claim, and resubmitting an unchanged claim does not move the refill date the plan is measuring against.

A new prescription rejects with the message that the product is not on the plan's formulary. Which step by the technician is most likely to resolve it?

• a.Submit a prior authorisation request, since every non-formulary reject is cleared that way
• b.Substitute a drug from the same class that the plan does cover and bill for it
• c.Send the plan's preferred alternatives to the prescriber and ask for a new prescription✓
• d.Tell the patient the drug is not covered and charge the cash price

A formulary reject is a coverage decision the pharmacy cannot overturn; what it can do is look up what the plan covers in that class and put those options in front of the prescriber, who is the only person able to write the new prescription. Prior authorisation is the closest wrong answer, and some plans do cover a non-formulary drug through an exception request, but that request also has to come from the prescriber with clinical justification and many plans exclude non-formulary products outright. Switching the drug inside the pharmacy dispenses something that was not prescribed, and quoting the cash price without offering a covered route gives the patient nowhere to go.

A claim rejects with 'prior authorisation required'. Which statement describes how that authorisation is actually obtained?

• a.The pharmacist approves it after documenting the need in the profile
• b.The prescriber submits clinical justification to the plan✓
• c.The patient telephones the plan and requests the authorisation
• d.The pharmacy forwards the patient's chart notes to the plan

Prior authorisation is a coverage decision the plan makes on the prescriber's clinical evidence, so the prescriber's office is the only party that can complete it; a technician may start the paperwork, notify the office and track the outcome. The patient's call is the closest wrong answer, because members can and do reach the plan's help desk, but the plan still turns to the prescriber for the clinical information before approving anything. The pharmacy does not hold the chart notes, and no pharmacist has authority over a plan's coverage decisions.

A claim rejects with a message that the patient must first try a preferred agent in the same class before this product will be covered. What is this plan requirement called?

• a.A prior authorisation requirement
• b.Therapeutic interchange by the pharmacy
• c.A step-therapy requirement✓
• d.A quantity limit

Step therapy makes coverage of the requested product conditional on a documented trial of the plan's preferred agent first. Prior authorisation is the closest wrong answer, and the two are often worked through the same help desk, but a prior authorisation asks for clinical justification of this drug while step therapy asks for evidence that a cheaper one was tried and failed. A quantity limit caps how much may be dispensed in a period, and therapeutic interchange is a substitution made under a protocol inside a health system rather than a claim reject.

Which piece of information belongs on the label of a prescription dispensed to a patient but is not required on the manufacturer's stock bottle it was counted from?

• a.The patient's name and the directions for use✓
• b.The product's National Drug Code in 11-digit format
• c.The name and address of the drug's manufacturer
• d.The lot number the manufacturer assigned to the production run

A dispensing label is a patient-specific document: it names the patient and carries the directions the prescriber wrote, and neither can appear on a manufacturer's bulk container that has no patient attached to it. The lot number is the closest wrong answer, because pharmacies do record lot numbers for repackaged products and immunizations, but the manufacturer must print it on the stock bottle while a retail dispensing label is not required to show it. The National Drug Code and the manufacturer's name and address are elements of the manufacturer's own labelling.

A pharmacy's cost of goods sold for the year was $1,200,000 and its average inventory value was $100,000. What is the inventory turnover rate?

• a.0.08 times a year
• b.12 times a year✓
• c.120 times a year
• d.1 time a year

Inventory turnover is the cost of goods sold divided by the average inventory value: $1,200,000 / $100,000 = 12, so the pharmacy sells and replaces the value of its shelf stock twelve times a year. Checking the same figure another way, $100,000 of stock turned twelve times supplies $1,200,000 of goods. Dividing in the opposite direction, $100,000 / $1,200,000, gives 0.08, using one month's cost of goods, $100,000 / $100,000, gives 1, and shifting the decimal one place gives 120.

What does a perpetual inventory of Schedule II drugs give a pharmacy?

• a.A record the wholesaler keeps for the pharmacy's audits
• b.A monthly reconciliation of purchases against the DEA Form 222 file
• c.A count of the entire controlled stock taken once every two years
• d.A running balance updated with every transaction✓

A perpetual inventory is a live running balance: every receipt adds, every dispensing subtracts, and the recorded quantity of a Schedule II drug can be compared with the shelf at any moment. The biennial count is the closest wrong answer, because federal law does require a complete controlled-substance inventory every two years, but that is a snapshot taken once every two years and it cannot show a loss in the week it happens. Reconciling against the Form 222 file covers only what was ordered, and the wholesaler's records document what was shipped rather than what left the pharmacy.

A stock bottle is labelled EXP 09/2026, with no day shown. What does that date mean for dispensing?

• a.Once the bottle is opened the printed date no longer applies and a six-month limit takes over
• b.The product may be dispensed through the last day of September 2026✓
• c.The product should have been pulled at the end of August 2026
• d.The product may be dispensed only through 1 September 2026

A manufacturer's expiration date printed as a month and a year runs through the last day of that month, so this bottle may be used up to and including 30 September 2026. Reading it as the first of the month is the closest wrong answer, and it errs on the safe side, but it discards a month of usable stock on every bottle in the pharmacy. An unopened manufacturer's container stored as labelled keeps its printed date; the shorter dating that starts when a container is opened belongs to products the pharmacy repackages or compounds.

A pharmacy sends expired Schedule II tablets to a DEA-registered reverse distributor. What documents that transfer of the drugs?

• a.A DEA Form 41 completed by the pharmacy when the courier collects them
• b.A signed inventory sheet kept in the pharmacy for two years
• c.A DEA Form 222 issued to the pharmacy by the reverse distributor✓
• d.The credit memo the reverse distributor returns

A transfer of a Schedule II substance moves on a DEA Form 222, executed by the registrant receiving the drugs, and that applies to expired stock going to a reverse distributor just as it does to a purchase. Form 41 is the closest wrong answer, because it is the controlled-substance disposal record, but it documents the actual destruction and is completed by the registrant who destroys the drugs rather than by the pharmacy handing them over. A credit memo and an internal inventory sheet are business records with no standing under the controlled-substance rules.

A technician repackages tablets from a bulk bottle into unit-dose blisters for a hospital's cabinets. Besides the blister labels, what must the repackaging record capture?

• a.The name of every patient who later receives one of the repackaged doses
• b.The source lot number and expiration date and the run's control number
• c.The drug name, strength and the number of packages produced
• d.The wholesaler's invoice number for the bulk bottle✓

A repackaging record has to make it possible to walk any unit-dose package back to the container it came from, so it captures the manufacturer's lot number and expiration date of the source bottle together with the internal control number placed on the run. Recording drug, strength and count is the closest wrong answer, because those details do belong in the log, but without the source lot number a recall cannot be traced and every package from that run has to be destroyed. Patient names belong to dispensing records, and an invoice number tracks a purchase rather than a package on a cart.

A hospital outpatient pharmacy fills prescriptions from 340B-purchased inventory. What has to be true before a given prescription may be filled from that stock?

• a.The patient must be enrolled in Medicaid on the day of the fill
• b.The prescription must be for a generic product with an AB rating
• c.The patient must be an eligible patient of the covered entity✓
• d.The patient must be uninsured, or below a stated income level

340B pricing follows the patient relationship: the drug has to go to a patient of the covered entity on a prescription arising from care the entity provided, and diverting that inventory to anyone else is exactly what program audits look for. Income or insurance status is the closest wrong answer, because 340B entities do serve low-income populations, but the discount is conditioned on the patient relationship and not on the patient's means. Medicaid enrolment matters only for the separate rule that stops a manufacturer paying a rebate on a drug already sold at the 340B price, and the program covers brand products as well as generics.

A mail-order pharmacy located in one state ships maintenance prescriptions to patients in thirty others. What does shipping into those states require?

• a.A nonresident pharmacy license in each state served✓
• b.Nothing beyond the license held in the pharmacy's home state
• c.Registration with the FDA as an out-of-state dispenser of drugs
• d.A staffed pharmacy location inside every state served

Pharmacy licensure follows the patient, so a mail-order operation needs a nonresident or out-of-state pharmacy license from the board of every state it ships into, on top of the license where it physically sits. Relying on the home-state license is the common misreading, and it is precisely what boards pursue when an unlicensed pharmacy ships across a border. The FDA registers manufacturers, repackagers and outsourcing facilities rather than dispensing pharmacies, and no state makes a physical location a condition of shipping in.

Electronic prescribing takes the prescriber's handwriting out of the process. Which new error should the technician watch for when an e-prescription arrives?

• a.A drug or strength picked from the wrong line of the prescriber's drop-down list✓
• b.The same prescription transmitted twice, so the patient is set up with a duplicate supply
• c.A decimal point misread because the dose was written with a trailing zero
• d.A transcription slip made as the pharmacy re-keys the directions

The characteristic e-prescribing error is a selection error: the prescriber clicks the line above or below the intended product and the pharmacy receives a clean, legible prescription for the wrong drug or the wrong strength, with nothing on its face to signal the mistake. Duplicate transmission is the closest wrong answer, and it does happen, but a duplicate arrives as two identical orders and is caught by the system's duplicate-therapy and refill-too-soon edits. Trailing-zero misreads and re-keying slips belong to handwritten and telephoned orders, which an e-prescription bypasses.

A non-controlled prescription is written for #30 with the note 'refill prn'. In most states, how should the refills be entered?

• a.As refills for two years, the federal limit for non-controlled drugs
• b.As refills sufficient to cover one year from the date written✓
• c.As unlimited refills until the prescriber cancels the prescription
• d.As five refills within six months of the date written

A note to refill as needed is not a license for perpetual refills: in most states a non-controlled prescription may be refilled for one year from the date it was written, so the entry is capped at that horizon, commonly eleven refills on a thirty-day quantity. Unlimited refills is the closest wrong answer, because the prescriber did write prn, but the prescription itself expires under state law whatever the note says. Five refills in six months is the federal limit for Schedules III and IV, and there is no federal two-year refill limit for non-controlled drugs.

Cefdinir 125 mg/5 mL oral suspension is prescribed as 3.75 mL by mouth twice daily for 10 days. What quantity should be dispensed?

• a.112.5 mL
• b.37.5 mL
• c.75 mL✓
• d.7.5 mL

Each day the patient takes 3.75 mL x 2 = 7.5 mL, and over 10 days that is 7.5 mL x 10 = 75 mL. Checking the same figure another way, twice daily for 10 days is 20 doses in all, and 3.75 mL x 20 = 75 mL. Counting one dose a day gives 37.5 mL and counting three a day gives 112.5 mL, while 7.5 mL is a single day's total rather than the quantity for the course.

Warfarin 5 mg tablets are prescribed as: take 1 tablet by mouth on Monday, Wednesday and Friday, and one-half tablet by mouth on each of the other days. Ninety tablets are dispensed. What is the day supply?

• a.90 days
• b.126 days✓
• c.18 days
• d.60 days

One week uses 3 x 1 tablet + 4 x 0.5 tablet = 3 + 2 = 5 tablets, so 90 tablets last 90 / 5 = 18 weeks, and 18 x 7 = 126 days. Checking the same figure another way, 5 tablets per 7 days is 0.714 tablets a day, and 90 / 0.714 = 126 days. Averaging the two dose sizes into 1.5 tablets a day gives 90 / 1.5 = 60 days, counting a whole tablet every day gives 90 days, and 18 is the number of weeks left unconverted.

A wholesaler delivery includes one bottle that expires in six weeks, of a drug the pharmacy dispenses about twice a year. What should the technician do with it?

• a.Shelve it behind the existing stock, which was received earlier
• b.Shelve it in front of the existing stock so it is used first
• c.Return the short-dated bottle to the wholesaler✓
• d.Move it to the quarantine shelf until the date passes

Wholesalers take short-dated stock back within a stated window, and returning it now recovers the money while that credit is still available; at roughly two dispensings a year this bottle will expire untouched on the shelf. Shelving it in front is the closest wrong answer, because first-expired-first-out is the correct rotation rule, but rotation only helps when the product will actually move before the date, which it will not here. Shelving by receipt date ignores expiration altogether, and holding it in quarantine until it expires turns a returnable bottle into waste.

A plan's contract says it pays the lower of the contracted rate or the pharmacy's usual and customary price. What is the usual and customary price?

• a.The average wholesale price less the plan's contracted discount
• b.The maximum allowable cost the plan sets for a multi-source generic
• c.The price a cash customer pays for that prescription✓
• d.The pharmacy's acquisition cost

The usual and customary price is what the pharmacy would charge a cash-paying customer walking in for that same prescription, and the plan pays that figure whenever it is lower than the contracted rate. Maximum allowable cost is the closest wrong answer, because it also caps what a plan will pay, but it is a ceiling the plan sets for a multi-source generic rather than a price the pharmacy sets. Acquisition cost is what the pharmacy paid for the drug and average wholesale price is a published list figure, and a cash customer is charged neither of them.

Which federal law required pharmacies to offer counselling and to carry out a prospective drug utilization review for Medicaid patients?

• a.The Health Insurance Portability and Accountability Act of 1996
• b.The Omnibus Budget Reconciliation Act of 1990✓
• c.The Drug Quality and Security Act of 2013
• d.The Poison Prevention Packaging Act of 1970

The Omnibus Budget Reconciliation Act of 1990 tied federal Medicaid funding to a prospective drug utilization review and an offer to counsel, and the states then extended both duties to patients generally. The privacy statute is the closest wrong answer, because it also governs what happens at the counter, but it controls the use and disclosure of health information rather than requiring any counselling offer. Child-resistant packaging comes from the 1970 packaging law, and drug supply-chain track-and-trace requirements from the 2013 statute.

Under the federal Controlled Substances Act, which of these prescription products is placed in Schedule V?

• a.Methylphenidate tablets for attention-deficit disorder
• b.Diphenoxylate with atropine tablets for diarrhea✓
• c.Alprazolam tablets for anxiety
• d.Buprenorphine film for opioid use disorder

Diphenoxylate combined with a subtherapeutic amount of atropine is a Schedule V product; the atropine is added specifically to discourage abuse of the opioid. Buprenorphine is the closest trap because it is also an opioid used in low doses under tight control, but it is Schedule III. Alprazolam is Schedule IV and methylphenidate is Schedule II.21 CFR 1308.15

Which statement correctly describes how Schedule III differs from Schedule IV under the Controlled Substances Act?

• a.Schedule III substances may be refilled five times, while Schedule IV substances may not be refilled
• b.Schedule III substances must be ordered on a DEA Form 222, while Schedule IV substances need no order form
• c.Schedule III substances have a greater potential for abuse than Schedule IV substances✓
• d.Schedule III substances have no currently accepted medical use in the United States

The schedules are ranked by abuse potential and dependence liability, so Schedule III sits above Schedule IV. Both have accepted medical uses, both are limited to five refills within six months, and only Schedule I and II substances require a DEA Form 222 or a CSOS order. Testosterone and acetaminophen with codeine are typical Schedule III products; alprazolam and zolpidem are Schedule IV.21 USC 812

While preparing a paper DEA Form 222 for a Schedule II order, a technician writes the wrong number of packages on one line. What does federal regulation require?

• a.The technician may line through the entry and initial the change, provided the pharmacist signs the form afterward
• b.The form must be voided and a new one prepared, because a supplier may not fill an order form that shows any alteration or erasure✓
• c.The line may be left as written, and the correct quantity noted on the packing slip when the order is received
• d.The entry may be corrected in ink and initialed if the supplier is telephoned before the form is mailed

A supplier is forbidden to fill an order form that is incomplete, illegible, or that shows any alteration, erasure or change, so the only remedy is to void the defective form and execute a fresh one; the voided form is retained with the pharmacy's Schedule II records. Crossing out and initialing is the tempting answer because that is how most other pharmacy records are corrected, but on an order form it is exactly what makes the document defective.

A pharmacy orders Schedule II products electronically through the Controlled Substance Ordering System (CSOS) instead of on paper. What does federal law require of the person who signs those orders?

• a.The signer must enter the pharmacy's shared CSOS password, which the wholesaler reissues each year
• b.The signer must be the pharmacist-in-charge listed on the pharmacy's DEA registration
• c.The signer must hold an individual CSOS digital certificate issued by the DEA✓
• d.The signer must fax a paper DEA Form 222 to the supplier

A CSOS digital certificate is issued by the DEA to a named individual — the registrant, or a person who holds power of attorney for ordering — and that certificate, not a shared store password, signs the electronic order. Naming the pharmacist-in-charge is tempting because that person usually does hold the power of attorney, but the rule is about who holds a certificate, not about the title. No paper form accompanies a CSOS order.

A pharmacy destroys expired Schedule II tablets on site and records the destruction on DEA Form 41. What does the DEA require about how that destruction is carried out?

• a.A DEA diversion investigator must be present in the pharmacy during the destruction
• b.The pharmacist-in-charge may destroy the drugs alone if their acquisition cost is under five hundred dollars
• c.A licensed reverse distributor must take possession before any Schedule II drug may be destroyed
• d.Two authorized employees must witness the destruction and sign the record✓

The destruction must render the substance non-retrievable, and the Form 41 record is witnessed and signed by two employees the registrant has authorized. Sending expired stock to a licensed reverse distributor is the tempting answer because it is what most community pharmacies actually do, but it is one lawful option rather than a requirement — a registrant may destroy on site and document it on Form 41.

A pharmacy confirms that a significant quantity of controlled substances has been stolen. In addition to completing DEA Form 106, what does federal regulation require?

• a.Written notice to the DEA field division office within one business day of discovering the loss✓
• b.Completing an internal audit first and notifying the DEA once the exact missing quantity is known
• c.Written notice to the DEA field division office within thirty days of discovering the loss
• d.Notifying the local police only, since Form 106 itself serves as notice to the DEA

On discovering a theft or significant loss the registrant must notify the DEA field division office in writing within one business day, and Form 106 follows. Waiting for the audit is the tempting answer, because Form 106 does ask for exact quantities and the pharmacy usually cannot state them on day one — but the notification clock runs from discovery, not from the completed count.21 CFR 1301.76

When a pharmacy takes its biennial controlled substance inventory, how must the quantities on hand be counted?

• a.Schedule II items must be counted exactly; Schedule III through V items may be estimated✓
• b.Every schedule may be estimated as long as a pharmacist signs and dates the inventory record
• c.Only Schedule II items are inventoried; Schedule III through V items are counted when ownership changes
• d.Every schedule must be counted exactly, including opened Schedule V syrups

Federal rules require an exact count of every Schedule II substance on hand. For Schedule III through V an estimated count is acceptable, except that a container holding more than 1,000 tablets or capsules must be counted exactly. Estimating everything is the tempting answer because it is true for most of the shelf, but it fails on the Schedule II requirement.21 CFR 1304.11

Federal law sets a minimum period for keeping controlled substance records at the registered location. What is that period, and how do state requirements interact with it?

• a.Two years, and a state board may require a longer period✓
• b.Two years, and no state may require longer because federal law preempts state record rules
• c.Five years in every state, because HIPAA extended the federal period
• d.Seven years, matching the federal retention period for business tax records

The federal floor is two years, and the records must be kept at the registered location and be readily retrievable. Federal law does not preempt stricter state rules here: many boards of pharmacy require three, five or more years, and the pharmacy follows whichever period is longer. HIPAA governs privacy documentation and does not set the retention period for controlled substance records.21 CFR 1304.04

Federal regulations govern how a pharmacy files the paper prescriptions it has dispensed. How must Schedule II prescriptions be filed?

• a.Interfiled with Schedule III through V prescriptions in one controlled substance file
• b.In a separate file that holds Schedule II prescriptions and nothing else✓
• c.In any arrangement the pharmacy chooses, provided the records can be produced within 72 hours of a DEA request
• d.Interfiled with non-controlled prescriptions and stamped with a red C

Schedule II prescriptions must be maintained in a file separate from every other prescription record. The red C answer describes the alternative available for Schedule III through V prescriptions, which may be kept in their own file or interfiled with non-controlled prescriptions if marked with a red C at least one inch high — an option that does not extend to Schedule II. Pharmacies using an electronic system that makes the records readily retrievable are excused from the red C marking.21 CFR 1304.04

A prescriber telephones an emergency oral prescription for a Schedule II drug and the pharmacist dispenses only the amount needed for the emergency period. What must happen next under federal regulations?

• a.The prescriber must deliver a written, signed prescription to the pharmacy within seven days✓
• b.The pharmacist must obtain a written prescription before the patient leaves the pharmacy
• c.The prescriber must deliver a written, signed prescription to the pharmacy within seventy-two hours
• d.No further paperwork is required once the oral order is entered in the profile

The prescriber has seven days to deliver the written, signed prescription covering the emergency oral order, and if it does not arrive the pharmacist must notify the DEA. Seventy-two hours is the closest wrong answer because that figure does appear in the Schedule II rules — it is the window for supplying the balance of a partially filled prescription, a different situation.21 CFR 1306.11

A pharmacy can supply only part of the quantity written on a Schedule II prescription because of a stock shortage. Under federal rules, what applies to the remaining quantity?

• a.It may be supplied whenever the wholesaler delivers, since the prescription is already on file
• b.It must be supplied within 72 hours, or the pharmacist must notify the prescriber✓
• c.It must be supplied within 30 days of the date the prescription was issued
• d.It requires a new prescription, since Schedule II prescriptions may not be partially filled

When the pharmacist cannot supply the full quantity, the balance may be dispensed within 72 hours; if that passes, the pharmacist must notify the prescriber and no further quantity may go out on that prescription. The 30-day answer is genuinely close, because a partial fill requested by the patient or the prescriber does allow the remainder to be filled up to 30 days after the prescription was written — but that is a requested partial fill, not a stock shortage.21 CFR 1306.13

A resident of a long-term care facility has a Schedule II prescription that the pharmacy dispenses in small amounts as the resident needs them. For how long do federal rules allow that prescription to be partially filled?

• a.Up to 72 hours from the first partial fill, as in a community pharmacy
• b.Up to 90 days from the date it was issued, matching a typical maintenance supply
• c.Up to six months from the date it was issued, as with Schedule III refills
• d.Up to 60 days from the date it was issued✓

For a patient in a long-term care facility, and for a patient the prescriber has documented as terminally ill, a Schedule II prescription may be partially filled for up to 60 days from the issue date unless it is terminated sooner. The 72-hour answer is the tempting one because that limit does govern partial fills in a community pharmacy that is simply out of stock; the long-term care provision is a separate, longer allowance.21 CFR 1306.13

Under federal law, how long after it is written may a Schedule II prescription still be filled?

• a.Federal rules set no fixed limit, and many state boards impose one of their own✓
• b.Federal rules allow six months, as with Schedule III refills
• c.Federal rules allow 90 days when the prescription is for a chronic condition
• d.Federal rules allow 30 days, after which the prescriber must write a new prescription

The DEA has not set a federal expiration date for filling a Schedule II prescription; it must be presented within a reasonable time and the prescriber's intent must still be current, but no number of days appears in the federal rule. Many state boards do set a limit, commonly 30, 60, 90 or 180 days, and the pharmacy follows its own state's rule. The six-month figure belongs to Schedule III through V refills, not to filling a Schedule II.

A patient asks a pharmacy to transfer the remaining refills on a Schedule IV prescription to a different pharmacy. What does federal law allow?

• a.Unlimited transfers, provided both pharmacists record the date and their initials
• b.No transfer at all, since prescriptions for any controlled substance may never be transferred between pharmacies
• c.One transfer of the remaining refills, unless the two pharmacies share a real-time online database✓
• d.Transfers back and forth between the pharmacies as often as the patient asks

Refill information for a Schedule III, IV or V prescription may be transferred one time only, and both pharmacists must document the transfer. Where the two pharmacies share a real-time, online database, transfers may be made up to the maximum number of refills authorized. The blanket no-transfer answer describes Schedule II prescriptions, which carry no refills to transfer in the first place.21 CFR 1306.25

Federal regulations permit certain Schedule V products that are not prescription drugs to be sold at retail without a prescription. What does federal law require of that sale, and what may a state do?

• a.A pharmacist must make the sale to a buyer at least 18 years old; a state may forbid it✓
• b.Any pharmacy employee may make the sale once the buyer signs the pseudoephedrine logbook and shows a photo ID
• c.Any pharmacy employee may make the sale to a buyer at least 21 years old, and no state may forbid it
• d.A pharmacist must make the sale, and only to a buyer already known to the pharmacy

Federal rules let a pharmacist personally sell a limited quantity to a purchaser at least 18 years of age, obtain identification from a purchaser not known to the pharmacist, and record the sale in a bound book. Federal law is only a floor here: many states require a prescription for these products, and where the state is stricter the state rule controls. Requiring the buyer to be already known to the pharmacy inverts the identification rule, which exists precisely for buyers who are not known.21 CFR 1306.26

A customer buys a pseudoephedrine product under the Combat Methamphetamine Epidemic Act. What does federal law require of the record of that sale?

• a.A logbook entry with photo identification, kept until the end of the calendar year
• b.A logbook entry signed by the pharmacist who made the sale, kept six months
• c.A logbook entry with photo identification, kept for two years✓
• d.An electronic record transmitted to the DEA within one business day of each sale

The seller records the product, the quantity, the purchaser's name and address and the date and time of sale, verifies photo identification, obtains the purchaser's signature, and keeps the logbook for at least two years after the last entry. Nothing is transmitted to the DEA at the point of sale, and federal law does not require a pharmacist to ring up the sale, although several states are stricter on that point.

A patient asks that all of her prescriptions be dispensed in easy-open containers because she has arthritis. Under the Poison Prevention Packaging Act, what may the pharmacy do?

• a.Honor the request for one prescription at a time, with a new request at each fill
• b.Refuse, because federal law waives child-resistant packaging only for named exempt drugs
• c.Honor a standing request from the patient that covers all of her prescriptions, and keep it on file✓
• d.Honor the request only if the prescriber writes a waiver on each prescription

The Act, enforced by the Consumer Product Safety Commission rather than the FDA, allows the patient to give a blanket request covering all of her prescriptions, and the pharmacy documents it. A prescriber's request is the narrower one — it applies only to the prescription on which it appears. Exempt products such as sublingual nitroglycerin are a separate provision and do not limit the patient's right to ask.

A manufacturer recalls several lots of a tablet because the outer carton misspells the company's mailing address. The drug itself and the directions for use are unaffected. How does the FDA classify this recall?

• a.Class III, a defect that is not likely to cause an adverse health consequence✓
• b.Class II, a defect that may cause temporary or medically reversible health harm
• c.Class I, since any labeling error creates a reasonable probability of serious harm
• d.A market withdrawal, since the FDA does not regulate carton printing

Class III covers situations where use of the product is not likely to cause any adverse health consequence, which fits a cosmetic misprint that does not touch the drug, its strength or its directions. Class II is the closest wrong answer and would apply if the labeling error could lead to a temporary or reversible harm, such as a wrong strength on the carton. A market withdrawal involves a minor issue that is not a violation the FDA would act on, and printed labeling is very much regulated.

Under the Drug Supply Chain Security Act, a pharmacy receives transaction information and a transaction statement with each shipment of prescription drugs. What must the pharmacy do with those records?

• a.Keep them for six years from the date of the transaction and produce them on request✓
• b.Keep them for two years, which is the period that applies to controlled substance records
• c.Return them to the wholesaler once the shipment has been checked in
• d.Keep them only for the products that are controlled substances

A dispenser must retain the transaction information and transaction statement for at least six years from the date of the transaction and be able to produce them, particularly when investigating a suspect or illegitimate product. The two-year answer is tempting because it is a real retention period in a pharmacy — it is the DEA's period for controlled substance records, a different law with its own clock. The Act covers prescription drug purchases generally, not only controlled substances.

A health plan telephones a pharmacy to ask about one patient's claim for a single medication. Which principle of the HIPAA Privacy Rule governs how much the technician may disclose?

• a.The patient authorization requirement, which bars disclosure without a signed release
• b.The treatment exception, which permits disclosure of the entire medication profile
• c.The minimum necessary standard✓
• d.The public health exception, which permits disclosure to any payer

Disclosures for payment are permitted without patient authorization, but they are limited to the minimum information necessary for the purpose — here, the single claim in question rather than the patient's whole medication history. The authorization answer is the tempting one because a signed authorization really is required for uses such as marketing; it is not required for payment activities.45 CFR 164.502

A patient reports high fever and extensive arm swelling that began the day after receiving an influenza vaccine at the pharmacy. Which federal system is used to report this event?

• a.The FDA MedWatch program, which receives reports on every FDA-regulated product
• b.The Vaccine Adverse Event Reporting System✓
• c.The state board of pharmacy, which forwards vaccine reports to the CDC
• d.The DEA field division office, using its adverse event report form

Adverse events following immunization go to VAERS, which the FDA and the CDC run jointly, and federal law requires health care providers to report certain post-vaccination events. MedWatch is the closest wrong answer because it genuinely does collect adverse events for drugs, biologics and devices, but vaccine events are routed to VAERS instead. The DEA has no role in adverse event reporting.

A pharmacy technician's duties include assisting with immunizations, so the OSHA Bloodborne Pathogens Standard applies. What must the employer make available?

• a.Hepatitis B vaccination at a cost shared equally by the employer and the employee
• b.Hepatitis B vaccination, but only after a documented needlestick injury
• c.Hepatitis B and hepatitis C vaccination at no cost to the employee
• d.Hepatitis B vaccination at no cost to the employee✓

The employer must offer hepatitis B vaccination free of charge, within 10 working days of the employee's initial assignment to work with occupational exposure; an employee who declines signs a declination form and may still accept the vaccine later. The needlestick answer inverts the rule, since the point of the standard is protection before an exposure occurs, and there is no hepatitis C vaccine to offer.29 CFR 1910.1030

The OSHA Hazard Communication Standard covers the hazardous chemicals a pharmacy keeps, such as disinfectants and compounding chemicals. What does it require of the safety data sheets?

• a.They must be kept in a locked cabinet with the pharmacist-in-charge holding the key
• b.They must be requested from the manufacturer only when an exposure occurs
• c.They must be readily accessible to employees on every shift✓
• d.They must be mailed to OSHA each year

Safety data sheets must be available to employees in their work area throughout each work shift, without having to ask permission or wait for someone with a key, which is why locking them away fails the standard even though the sheets are on the premises. Requesting a sheet only after an exposure defeats the purpose, since the sheet is what tells the employee how to respond.29 CFR 1910.1200

A drug's Risk Evaluation and Mitigation Strategy includes elements to assure safe use (ETASU). What does that add beyond a medication guide?

• a.The manufacturer must supply the drug to any pharmacy that orders it and pay for all patient monitoring
• b.Prescribers, pharmacies and patients may have to be certified or enrolled before dispensing✓
• c.The FDA reviews each individual prescription before it may be filled
• d.The drug is placed in a DEA schedule matching the seriousness of the risk it carries

ETASU can require prescriber certification, pharmacy certification, patient enrollment in a registry, documented laboratory monitoring, or dispensing only in certain settings, so a pharmacy that is not certified simply cannot dispense the product. A REMS is an FDA requirement and has no connection to DEA scheduling, and the FDA does not review individual prescriptions.

Two products carry the same AB therapeutic equivalence code in the Orange Book. What determines whether the pharmacy may actually dispense one in place of the other?

• a.The FDA's approval letter, which names the products that may be dispensed in place of the brand
• b.The wholesaler's purchasing contract, which lists the products a pharmacy may interchange
• c.The AB rating by itself, which authorizes substitution in every state
• d.State substitution law, since the AB rating by itself does not authorize a substitution✓

An AB code tells the pharmacy that the FDA considers the products therapeutically equivalent, but the authority to dispense one for the other comes from state substitution law, which varies on points such as patient notification, prescriber consent, and whether substitution is mandatory or permissive. The AB rating is a necessary condition in most states rather than the permission itself, which is why relying on the rating alone is the tempting error.