20 Regulatory & Administrative Practice Questions & Answers

1. 1. A patient completes a contact lens fitting and the practice is willing to sell her lenses. She never asks for her prescription. Under the FTC Contact Lens Rule, what must the prescriber do at that visit?

   • A.Provide the prescription only after she buys her first supply of lenses from the office.
   • B.Send the prescription directly to an outside seller when that seller contacts the office.
   • C.Hold the prescription in the chart and release it only after a written request arrives.
   • D.Give her a copy of the prescription at that visit even though she never asked for one.✓ Answer

   The FTC Contact Lens Rule requires the prescriber to give the patient a copy of the contact lens prescription at the completion of the fitting, automatically and whether or not the patient asks for it. A fitting is complete once a successful fit is achieved, and FTC guidance treats a willingness to sell the patient lenses as proof the fitting is complete, so the copy cannot be held back.

   Source: FTC Contact Lens Rule, 16 CFR 315.3(a)(1) — automatic prescription release at completion of the fittingReport a problem with this question

2. 2. A practice wants patients to sign a form saying the office is not responsible for the accuracy of the eye examination before it hands over the contact lens prescription. How does the FTC Contact Lens Rule treat that form?

   • A.The office may use the waiver if the patient is told that signing it is optional.
   • B.The office may use the waiver whenever the patient intends to buy lenses online.
   • C.The office must release the prescription with no liability waiver attached to it.✓ Answer
   • D.The office may require the waiver before it answers a seller's verification telephone call.

   The Contact Lens Rule bars a prescriber from placing on the prescription, requiring the signature of, or delivering any form that waives or disclaims liability for the accuracy of the eye examination. The same part of the Rule also forbids conditioning release or verification on the purchase of lenses or on any payment beyond the examination and fitting fee.

   Source: FTC Contact Lens Rule, 16 CFR 315.8 (prohibited waiver of liability) and 16 CFR 315.3(b)Report a problem with this question

3. 3. At the end of a fitting the technician hands the patient her prescription and asks her to sign a statement confirming she received it. The patient refuses to sign. What does the FTC Contact Lens Rule require next?

   • A.Note the refusal on the confirmation document, sign it, and let her keep the prescription.✓ Answer
   • B.Keep the prescription copy in the chart until she returns and signs the confirmation.
   • C.Have the office manager sign the patient's name and file the statement as complete.
   • D.Ask her to sign the same confirmation wording in the intake paperwork at her next visit.

   The Rule requires the prescriber to request a signed confirmation that the patient received the prescription, but the patient's signature is never a condition of release. If the patient declines, the prescriber notes the refusal on the document and signs it, and the record is kept for the Rule's retention period. The request must also come after the prescription is handed over, not inside pre-appointment intake paperwork.

   Source: FTC Contact Lens Rule, 16 CFR 315.3(c) — confirmation that the prescription was providedReport a problem with this question

4. 4. A staff member checks that a written contact lens prescription is complete before it is handed to the patient. Which item does the FTC Contact Lens Rule require the prescription to carry?

   • A.The expiration date of the prescription together with its date of issue.✓ Answer
   • B.The keratometry readings recorded for each eye at the fitting visit.
   • C.The brand of care solution the patient was told to use with the lenses.
   • D.The patient's vision insurance policy number and the plan's group number.

   The Rule defines what a contact lens prescription must contain: the patient's name, the examination date, the issue and expiration dates, the prescriber's name, address, telephone and fax numbers, the power, the material or manufacturer, the base curve or an appropriate designation, the diameter where appropriate, and private-label details where they apply. Keratometry, insurance data and solution brand belong in the chart, not on the prescription.

   Source: FTC Contact Lens Rule, 16 CFR 315.2 — definition of a contact lens prescriptionReport a problem with this question

5. 5. A prescriber wants a contact lens prescription to expire six months after it is issued. Under the FTC Contact Lens Rule, when is an expiration shorter than one year permitted?

   • A.When the state board of optometry sets a shorter standard period for all prescriptions.
   • B.When the prescriber's medical judgment about the patient's ocular health supports it and is documented.✓ Answer
   • C.When the patient is new to lens wear and the office schedules a six-month follow-up visit.
   • D.When the lens ordered is a custom made-to-order design rather than a stock replacement lens.

   The Rule sets a one-year floor: a prescription expires on the date state law provides if that date is one year or more after issue, and otherwise no sooner than one year after issue. A shorter period is allowed only on the prescriber's medical judgment about the patient's ocular health, with the specific reasons documented in the record and retained. State rules that shorten expiration below a year are preempted, while a longer state period governs.

   Source: FTC Contact Lens Rule, 16 CFR 315.6 — prescription expiration, and 16 CFR 315.11 preemptionReport a problem with this question

6. 6. An online seller sends a complete verification request to the prescriber's office and gets no answer of any kind within eight business hours. Under the FTC Contact Lens Rule, what may the seller do?

   • A.Fill the order only after the patient signs a statement accepting the risk.
   • B.Cancel the order, because silence from a prescriber blocks the sale entirely.
   • C.Substitute a lens from another manufacturer with the same parameters listed.
   • D.Fill the order as submitted, because the prescription counts as verified.✓ Answer

   If the prescriber does not communicate with the seller within eight business hours of a complete verification request, the prescription is verified by operation of law — passive verification — and the seller may fill the order as written. The way to stop the sale is to respond inside the window stating that the prescription is inaccurate, expired or otherwise invalid, and the prescriber carries no liability for lenses dispensed on a passively verified prescription.

   Source: FTC Contact Lens Rule, 16 CFR 315.5(c) — verification and passive verificationReport a problem with this question

7. 7. A seller's verification request reaches a prescriber's office at 7 p.m. on a Tuesday. In counting the eight business hours allowed for a response, which clock governs?

   • A.Whatever hours the office posts on its door, weekend clinic sessions included.
   • B.Hours from 9 a.m. to 5 p.m. on weekdays in the time zone of the seller.
   • C.Every hour the seller's website takes orders, counted straight through the night.
   • D.Hours from 9 a.m. to 5 p.m. on weekdays in the prescriber's own time zone.✓ Answer

   The Rule defines a business hour as an hour between 9 a.m. and 5 p.m. on a weekday, excluding federal holidays, measured in the prescriber's time zone. A request that arrives after hours starts the clock at 9 a.m. on the next qualifying weekday, so a 7 p.m. Tuesday request runs during Wednesday's business hours. Saturday hours count only at the seller's option and only when the seller actually knows the office's regular Saturday hours.

   Source: FTC Contact Lens Rule, 16 CFR 315.2 — definition of business hourReport a problem with this question

8. 8. A patient's sister, acting as the patient's designated agent, telephones and asks for a copy of the contact lens prescription. Under the FTC Contact Lens Rule, how fast must the office respond?

   • A.Within three business days, once the caller has mailed a signed release to the practice.
   • B.Within thirty calendar days, the deadline that applies to a request for medical records.
   • C.Within eight business hours, the same window the Rule gives for answering a verification request.
   • D.Within forty business hours, by sending the copy or reporting that it is no longer valid.✓ Answer

   A request from a person the patient has designated must be answered within forty business hours by providing or verifying the prescription, or by stating that it is inaccurate, expired or otherwise invalid. That forty-hour window for a copy is a different clock from the eight-business-hour window a seller's verification request starts. The record should also note the requester's name and the date and time the prescription was released.

   Source: FTC Contact Lens Rule, 16 CFR 315.3(a)(2)-(a)(3) — release to a patient-designated personReport a problem with this question

9. 9. An online retailer telephones to verify a prescription the patient asked it to fill. A new employee wants to refuse until the patient signs a HIPAA authorization. What is the correct handling?

   • A.Answer the verification request, because disclosure to a patient-chosen seller needs no authorization.✓ Answer
   • B.Refuse the call until a signed HIPAA authorization form arrives from the patient by mail or fax.
   • C.Refer the seller to the practice's privacy officer, the one person who may confirm parameters.
   • D.Answer only the parts of the request that repeat what the seller has already stated correctly.

   FTC guidance on the Contact Lens Rule explains that the HIPAA Privacy Rule permits use and disclosure without patient authorization for treatment and where a disclosure is required by law, and providing, confirming or correcting a prescription for a seller the patient designated is both. Refusing to verify until an authorization is signed is not privacy compliance; it breaches the verification and release duties the Rule imposes.

   Source: FTC Contact Lens Rule verification duties, 16 CFR 315.5, with FTC guidance on the HIPAA Privacy RuleReport a problem with this question

10. 10. An office is setting a retention period for the records the FTC Contact Lens Rule makes it keep, such as signed release confirmations and verification logs. How long must those records be kept?

    • A.At least ten years, the period used for hospital chart retention.
    • B.At least one year, running to the prescription's expiration date.
    • C.At least three years from the date each record was made.✓ Answer
    • D.At least six years, the period set for HIPAA policy documents.

    The Contact Lens Rule requires prescribers to keep the records it creates — signed confirmations that the prescription was provided, evidence of consented digital delivery, and documentation supporting an expiration shorter than one year — for at least three years and to make them available to the FTC. The six-year clock is HIPAA's policy and documentation retention, a separate requirement, and medical-record retention itself is set by state law.

    Source: FTC Contact Lens Rule recordkeeping, 16 CFR Part 315, contrasted with HIPAA documentation retention, 45 CFR 164.530(j)Report a problem with this question

11. 11. A costume shop plans to sell plano colored contact lenses that carry no refractive power. How does federal law treat those lenses?

    • A.They are cosmetics and may be sold over the counter to any adult buyer.
    • B.They are medical devices and may be sold only on a valid prescription.✓ Answer
    • C.They are exempt devices as long as no corrective power is built into them.
    • D.They are restricted only in states that license contact lens fitters.

    Federal law deems all contact lenses medical devices, including plano decorative and cosmetic lenses that correct nothing, so they need FDA clearance and a valid prescription and the FTC Contact Lens Rule applies to them just as it does to corrective lenses. Contact lens care solutions are regulated as medical devices as well, which is why their labeled directions have to be followed exactly as written.

    Source: FD&C Act provision deeming all contact lenses, including decorative plano lenses, medical devices; FTC Contact Lens Rule coverage of decorative lensesReport a problem with this question

12. 12. In the FDA classification of the soft (hydrophilic) contact lens, what decides whether a particular lens is a Class II or a Class III device?

    • A.The wear schedule intended for it, daily wear against extended wear.✓ Answer
    • B.The water content of the hydrogel material the lens is made from.
    • C.The oxygen transmissibility the finished lens reaches on the eye.
    • D.The replacement interval the manufacturer prints on the carton label.

    Under the FDA classification regulation for the soft (hydrophilic) contact lens, a lens intended for daily wear only is a Class II device cleared through the 510(k) substantial equivalence route, while a lens intended for extended, overnight wear is Class III and requires premarket approval. Classification follows the intended wear schedule, not the material, the water content or the oxygen transmissibility.

    Source: FDA device classification for the soft (hydrophilic) contact lens, 21 CFR 886.5925Report a problem with this question

13. 13. A manufacturer recalls a lot of contact lenses after reports that using them could cause serious permanent injury, and the notice calls it a Class I recall. What does that class describe?

    • A.The number of production lots the firm has pulled back from sale.
    • B.The severity of the health hazard that the recalled product presents.✓ Answer
    • C.The marketing pathway the lens used, either 510(k) clearance or PMA.
    • D.The device risk category under which the lens was cleared by FDA.

    FDA recall classes describe how dangerous the problem is, not how the device itself is classified. A Class I recall means there is a reasonable probability that use will cause serious adverse health consequences or death, Class II means temporary or medically reversible harm, and Class III means harm is unlikely. Device Classes I, II and III are a separate scheme of regulatory controls, so a Class II device can be subject to a Class I recall.

    Source: FDA recall classification (Class I, II, III recalls) contrasted with device classification under 21 CFR Part 886Report a problem with this question

14. 14. A recall notice arrives naming specific lot numbers of a lens the practice dispenses. What is the practice's first step?

    • A.Wait for patients to call with symptoms before searching the dispensing log for lots.
    • B.Keep dispensing the remaining stock until the manufacturer ships replacement lenses.
    • C.Pull the named lots from stock and stop dispensing them while patients are identified.✓ Answer
    • D.Discard every diagnostic lens held in the office, since lot numbers cannot identify them.

    A recall is actionable only because inventory is tracked by lot and serial number. The named lots are quarantined and dispensing stops at once, the dispensing log identifies which patients received lenses from those lots so they can be contacted, and the manufacturer's return or replacement instructions are followed and documented. Device-related patient injuries are reported to FDA through the MedWatch program.

    Source: FDA recall handling and device tracking by lot/serial number; adverse event reporting under 21 CFR Part 803 (MedWatch)Report a problem with this question

15. 15. A patient brings in a current spectacle prescription and asks the office to supply contact lenses using the powers written on it. What is the correct response?

    • A.Contact lenses can be ordered from spectacle powers once vertex distance is applied.
    • B.Contact lenses are dispensed only on their own prescription, with base curve and diameter.✓ Answer
    • C.Contact lenses are supplied when the spectacle prescription was written within the past year.
    • D.Contact lenses take the spherical equivalent of the spectacle powers as written on the form.

    A spectacle prescription is issued under the FTC Eyeglass Rule and describes lenses worn away from the eye, so it carries no base curve, diameter, material or brand and says nothing about how a lens behaves on the cornea. A contact lens prescription is a separate document issued under the FTC Contact Lens Rule only after a fitting and an on-eye evaluation, which is why the two are never interchangeable.

    Source: FTC Contact Lens Rule, 16 CFR Part 315, contrasted with the FTC Eyeglass Rule, 16 CFR Part 456Report a problem with this question

16. 16. A technician spends fifteen minutes teaching a new wearer insertion, removal, the wearing schedule and warning signs, but writes none of it in the chart. Why does that omission matter?

    • A.Education time sets the fitting fee that may be billed to the patient's vision plan.
    • B.Education must be recorded before the lens order can go to the manufacturer.
    • C.Education notes are the only chart entry the FTC reviews in a records audit.
    • D.Education that is not recorded is treated afterward as education never given.✓ Answer

    The contact lens record is the practice's evidence of what was fitted, dispensed and advised. Instruction in application and removal, the wearing and replacement schedule, lens care, and the warning signs that call for removing the lenses and telephoning the office are all part of the duty to warn, and an entry that does not exist cannot later show the warning was given. The chart should also carry each parameter change and the reason for it.

    Source: Contact lens practice standards on charting and duty to warn; NCLE Contact Lens Registry Examination content outline, Regulatory and Administrative domainReport a problem with this question

17. 17. Before an order for a patient's lenses is transmitted to the manufacturer, what should the staff member compare the order against?

    • A.The written prescription, checking eye, power, base curve, diameter, brand and quantity.✓ Answer
    • B.The manufacturer's promotional pricing on annual supplies of that lens brand.
    • C.The patient's last order, so that the parameters stay the same over time.
    • D.The trial lens the patient wore during the diagnostic fitting appointment.

    Every order is checked against the written prescription — patient name and eye, power, base curve, diameter, material or brand, and quantity — before it leaves the office, because a transcription error becomes a lens on a patient's eye. The order is also checked against the manufacturer's available parameter range: a value outside the stock range means a custom made-to-order lens, which is usually non-returnable.

    Source: NCLE Contact Lens Registry Examination content outline, Regulatory and Administrative domain — ordering procedures and order verificationReport a problem with this question

18. 18. A custom lens is being returned to the manufacturer for warranty exchange. Which handling reflects sound office procedure?

    • A.Credit the patient from petty cash and discard the lens without notifying anyone.
    • B.Log the return with its lot number and reason, then follow the exchange terms.✓ Answer
    • C.Hold the lens in the chart envelope until the patient's annual examination is due.
    • D.Place the returned lens into the diagnostic set for the next similar patient.

    A warranty return is a tracked process rather than a discard: the lens is logged with its parameters, lot or serial number and the clinical reason for the exchange, the manufacturer's authorization and return instructions are followed, and the replacement is recorded when it arrives so the chart shows every parameter the patient has worn. A lens that has been on a patient's eye never goes back into diagnostic inventory.

    Source: NCLE Contact Lens Registry Examination content outline, Regulatory and Administrative domain — inventory techniques and product orderingReport a problem with this question

19. 19. A single-use soft trial lens has been worn by a patient during a diagnostic fitting and removed after the evaluation. What should be done with that lens?

    • A.Rinse it with sterile saline and return it to the trial set for the next patient.
    • B.Discard it, because a single-use trial lens never goes on a second patient's eye.✓ Answer
    • C.Run it through the office thermal unit and put it back in its labeled stock drawer.
    • D.Store it in fresh disinfecting solution labeled with the patient's name for later.

    Single-use diagnostic lenses are supplied sterile for one patient and are discarded after that patient's evaluation; only lenses the manufacturer labels as reusable diagnostic lenses may be disinfected according to the labeled instructions and used again. Standard precautions apply around them: hand hygiene before handling any lens, and disinfection between patients of surfaces the patient touches, such as the slit lamp chin rest and forehead band.

    Source: Infection control for diagnostic contact lenses: manufacturer labeling plus CDC standard precautions and OSHA bloodborne pathogens standard, 29 CFR 1910.1030Report a problem with this question

20. 20. A wearer telephones the dispensary with pain, redness that does not clear after she removes the lenses, and light sensitivity. Her prescription is current. What is the correct action?

    • A.Send a fresh supply of lenses and ask her to try the new pair for a week.
    • B.Change her to a flatter base curve from stock and recheck her in two weeks.
    • C.Advise a rewetting drop every hour and reassess if symptoms last past the weekend.
    • D.Tell her to keep the lenses out and arrange a same-day visit with the prescriber.✓ Answer

    Pain, redness that persists after the lenses come out, photophobia, reduced vision or discharge are red flags for corneal infection or inflammation, so the lenses stay out and the patient is seen the same day by the prescriber. A fitter dispenses and educates within the prescriber's direction and within his or her own state's requirements; changing a parameter, re-fitting or extending a prescription is the prescriber's decision.

    Source: Contact lens follow-up red flags and referral to the original prescriber; NCLE Contact Lens Registry Examination content outline, Regulatory and Administrative domainReport a problem with this question

Practice questions based on the ABO-NCLE Contact Lens Registry Exam content domains and standard contact lens references, together with the FTC Contact Lens Rule and FDA device classification. This site is not affiliated with or endorsed by ABO-NCLE. Contact lens fitting is regulated state by state — scope of practice, supervision and licensure requirements vary, so confirm your own state's rules and work under the prescriber's direction. Verify current exam requirements with ABO-NCLE before testing. About the ABO-NCLE exams →