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College of Pharmacy

Washington State University

Review Questions about State Laws & Regulations

William E. Fassett, Ph.D., R.Ph.

Dean and Professor

I believe the following table covers two types of questions regarding the laws and regulations governing pharmacy in most states. Some cover the general structure for regulating practice in the state, but most deal with practical issues facing pharmacists. If a pharmacist or student can find the answer to most of these questions as it pertains to the law of a state in which he or she wishes to be licensed, then he or she should be prepared for a large percentage of the questions that are typically found on state pharmacy law examinations. This is not a complete list of possible questions, however. Also, some of these questions or situations are not specifically addressed by pharmacy regulations in some states.

If you have suggestions for additional questions I should add to the following list, please e-mail me at fassett@wsu.edu

My recommendations for preparing for a state law exam:

Read completely whatever material the Board of Pharmacy provides to all applicants.
Review a text or other material on federal law, and pay particular attention to regulations dealing with controlled substances.
Obtain and review the DEA publication, “Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act of 1970,” March 2001. This is available from any DEA regional office, or is available on the website of the DEA’s Office of Diversion Control (http://www.deadiversion.usdoj.gov/pubs/manuals/index.html) .
Attend, if desired, an update or review session covering recent changes in the state law.
Attempt to find answers to at least each of the following questions as they apply to the state you are attempting to become registered in. If you find specific questions that don’t seem to be covered in your state law material, check with a pharmacist from your state to see if they can tell you what the practice would be. You may also find that the state board will respond to a limited number of questions about specific situations.
In my experience, states emphasize ambulatory or community practice in their examinations, so this list does not include much concerning institutional, long-term care, home i.v., nuclear pharmacy, or other specialized practices. If your state has extensive regulations for any or all of these settings, be sure to learn how the regulations differ in each setting. It may be helpful to create a comparison chart concerning at least the following areas: labeling of containers dispensed or administered to patients; controlled substance record keeping; rules for access to the pharmacy if a pharmacist is not present; special requirements to practice or supervise the practice site; type of license binding; rules for use of technicians; and special policies or procedures that must be developed.
Talk with other pharmacists who have taken the state law examination recently and determine any areas they remember that surprised them or that they were unprepared for.
Get a good night’s sleep prior to the exam.
My students in recent years have had above a 90% pass rate on their first attempt at law exams. If you have done well in your rotations, and have taken time to review for the law exam, you should expect to pass. So relax, and prepare to enjoy your future as a licensed pharmacist.

General Review Questions to Prepare for State Pharmacy Law Exams

No.	Questions	Your Notes
1.	How many members serve on the Board of Pharmacy? How many are public members?
2.	Which of the following can prescribe legend drugs: O.D., Nurse Practitioner, Clinical Nurse Specialist, Physician’s Assistant, Midwife, Nurse Midwife, Chiropractor, Naturopath, Pharmacist?
3.	Which of the following can prescribe CSA drugs (and which classes): O.D., Nurse Practitioner, Clinical Nurse Specialist, Physician’s Assistant, Midwife, Nurse Midwife, Chiropractor, Naturopath, Pharmacist?
4.	How long are prescriptions for legend drugs valid from the date issued?
5.	Is there a maximum number of refills allowed for legend drugs? What is it?
6.	How long are prescriptions for each of the following valid: C-2s, C-3s, C-4s, C-5s?
7.	Is there a maximum number of refills allowed for C-5s? What is it? Are the number of refills for C-3s and C-4s the same as federal or less?
8.	Which of the following must be on the label of an outpatient prescription: Pt. address, Quantity, Expiration Date, Lot number, Name of drug, RPh initials, Technician initials, Pharmacy telephone number?
9.	Can the prescribed brand name be placed on the label when a generic is dispensed? If so, what wording is required?
10.	Is generic substitution subject to: positive formulary, negative formulary, other requirements?
11.	Must generic savings be passed on to patients? If so, what proportion, and how determined?
12.	How can a prescriber indicate that substitution is or is not permitted?
13.	Do patients have the option of demanding the brand name when substitution is permitted? How about patients whose prescriptions are paid for by public funds?
14.	What documentation is required of the pharmacist when product interchange is performed?
15.	Under what conditions, if any, is therapeutic substitution allowed?
16.	What minimum sets of references, products, or equipment are required in all community pharmacies?
17.	Do pharmacy hours have to be posted? Where?
18.	Can the store be open but the pharmacy department closed? Under what requirements?
19.	Do pharmacist licenses have to be on display? The original or official copy? Is a photocopy ok?
20.	Are there any required notices that must be displayed to the public?
20a.	Is a separate patient counseling area required?
21.	Is OBRA counseling required for Medicaid only or all patients?
22.	How must the offer to counsel be made?
23.	Does the offer to counsel need to be documented? Does the refusal of the offer need to be documented? How?
24.	Is counseling required on new prescriptions, refills, or both?
25.	Can printed materials satisfy the counseling requirement? Under what circumstances?
26.	What about prescriptions that are delivered or mailed to the patient?
27.	Are there any special requirements for mail order pharmacies?
28.	Under what circumstances may a pharmacist fill prescriptions written in another state?
29.	Is there any provision for dispensing an emergency refill supply of legend drugs when there are no refills left and the prescriber cannot be contacted? What is allowed/required?
30.	Are patient profiles required for all patients?
31.	What information is required on the profile?
32.	What use of the profile is required? Review prior to dispensing new Rx’s? Review prior to refills?
33.	What is expected to be looked for during profile review?
34.	Can a patient refuse to give certain information for the profile? If so, must the refusal be documented, and how?
35.	What are the requirements for use of computers to process prescriptions?
36.	What must be done if the computer system goes down?
37.	Is there any requirement for a daily printout of prescriptions that were entered into the computer? Who must sign the printout?
38.	Can a pharmacist legally repackage another pharmacy’s prescription? Under what circumstances?
39.	Can legend drug prescriptions be FAXed? Under what circumstances and requirements?
40.	Can legend drug prescriptions be transferred electronically (ie, by computer)? Under what circumstances and requirements?
41.	Under what circumstances are FAXed CSA prescriptions allowed?
42.	Can refills of legend drugs be transferred from one pharmacy to another? Can they be transferred back?
43.	Can an intern transfer refills?
44.	Must information regarding the transfer of legend drugs be recorded on the hard copy of the original prescription, or can it merely be recorded in the computer?
45.	What information must be recorded by the transferring pharmacy?
46.	What information must be placed on the original copy of the transferred prescription by the receiving pharmacy?
47.	Is it possible for pharmacies under a common ownership to share a single patient/prescription database? If so, what are the rules for prescription transfers?
48.	How long must the pharmacy maintain the following records: original prescriptions, refill records, drug purchase records, patient profiles? Are any of these different for CSAs? If any of these can be maintained on computer, how long do they need to be maintained "on-line?"
49.	Must every pharmacy have a pharmacist-in-charge?
50.	Are there any special requirements to be pharmacist-in-charge?
51.	May a person be pharmacist-in-charge for more than one pharmacy?
52.	When must the Board of Pharmacy be notified of any of the following? Change of pharmacist-in-charge, change of pharmacy address, closing or sale of a pharmacy, change of pharmacy telephone number, change of an individual pharmacist’s address, change of an intern’s address, change of a technician’s address, change of a person’s name?
53.	What must be on the label of a unit-dose or single-dose package of a legend drug dispensed for a patient in a hospital or nursing home?
54.	What must be on the label of a multiple-dose container dispensed for a patient in a hospital? In a nursing home?
55.	What is required on the label of a parenteral solution dispensed for a patient in a hospital?
56.	What is required on the label of a parenteral solution dispensed to a patient for home infusion therapy?
57.	What is required on the label of a radiopharmaceutical agent?
58.	What are special requirements, if any, to be a nuclear pharmacist?
59.	Can transfers of refill information be faxed between pharmacies?
60.	How rapidly must a pharmacy respond to a patient’s request to amend the information in his or her medication record?
61.	May a pharmacy transmit a patient’s prescription claim information electronically to a third party payor without the patient having provided written consent to the payor or the pharmacy?
62.	When must a pharmacy provide a copy of its Notice of Privacy Practices to a patient or other person requesting one?
63.	How can changes in the NOPP be communicated to patients?
64.	Can a non-custodial parent act on behalf of a minor to authorize disclosure of information in the patient medication record?
65.	What is the maximum amount of pseudoephedrine that can be sold OTC to an individual in a given day?