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Virginia Board of Pharmacy
Frequently Asked Questions

The Board receives frequent questions from pharmacists, consumers, and other health care professionals concerning laws and regulations related to the lawful possession, administration, dispensing, distribution, delivery, prescribing, and other disposition of prescription drugs in Virginia.  Answers to some of the most frequently asked questions will be posted here for your convenience, so keep checking back here as we build Pharmacy's FAQ content. Please feel free to send your suggested FAQ for posting to pharmbd@dhp.virginia.gov.

Most of the listed references may be found either under
 Laws and Regulations or Guidelines.

 

Questions Related to Pharmacist Licensing

What is the benefit of having an inactive license?

If a pharmacist does not plan to practice pharmacy in Virginia, taking inactive status will cost less in renewal fee and the pharmacist does not have to obtain 15 hours continuing education (CE) each year. If a pharmacist decides to reactivate an inactive license, he or she will need pay the difference between the active and inactive fee and to obtain the total amount of CE that would have been required during that time period. However, it may be obtained at any time between the date inactive status is taken and the date of reactivation. For example, if a pharmacist has been inactive for 3 years, 45 hours of CE is due to reactivate, but all 45 hours may have been obtained the week prior to the reactivation request, rather than 15 hours dated within each year.  Reference: Law- §54.1-3314.1 (I) and Regulation- 18 VAC 110-20-90 (F)

How many practical experience hours are required in Virginia prior to applying for a license?

If enrolled in pharmacy school prior to January 1, 1999, 1000 hours are required. For students enrolled after January 1, 1999, 1500 hours are required, and at least 300 must be obtained outside the school practical experience program. At least 300 hours must be in the area of "compounding and dispensing" within a pharmacy.  Reference: Regulation- 18 VAC 110-20-30.

Does Virginia allow reciprocity with Florida?

Virginia allows any pharmacist who holds a current and unrestricted license in another state, including Florida, to be licensed in Virginia provided that pharmacist meets all Virginia requirements for licensure by examination including a passing score on the national licensing examination developed by the National Association of Boards of Pharmacy (NABP) and on Virginia's law examination, and provided no grounds exist to deny the license.  Reference: §§54.1-3313 and 54.1-3316

Does Virginia participate in NABP's score transfer program for transfer of NAPLEX scores when the examination is taken in another state?

Yes. For details refer to NABP's NAPLEX registration bulletin.  Reference: NAPLEX registration bulletin

What are the requirements for a graduate of a foreign school of pharmacy to become licensed in Virginia?

First a graduate of a foreign school of pharmacy must have his or her education certified as being equivalent to a school of pharmacy which has been accredited by the American Council on Pharmaceutical Education (ACPE). This is done by a committee of the National Association of Boards of Pharmacy (NABP) and application must be first made to NABP using the NABP application form. This review and certification of education by the NABP committee may take several months. In addition, NABP and the Virginia Board of Pharmacy require a passing score on the Test of English as a Foreign Language (TOEFL) and the Test of Spoken English (TSE). Once these requirements are met, a graduate of a foreign school of pharmacy may then be approved by NABP to take the Foreign Pharmacy Graduate Equivalency Examination (FPGEE). The FPGEE has just been converted to a computerized examination format. Once approved the candidate may schedule the examination at his or her convenience. Also prior to applying for licensure in Virginia, a pharmacy school graduate must have completed a period of practical experience in the United States as an intern. If the experience is gained in Virginia, the applicant must be registered with this Board as a pharmacy intern. Any hours earned in another state must be certified by that state. For persons who were enrolled in a school of pharmacy prior to January 1, 1999, 1000 hours practical experience must be obtained. For persons enrolled in pharmacy school after January 1, 1999, 1500 hours are required. After the above listed requirements are met (1. certification of education, 2. TOEFL, 3. TSE, 4. FPGEE, and 5. practical experience), the person may apply to the Virginia Board of Pharmacy using the Virginia application for licensure as a pharmacist by examination. The application is reviewed and if approved, then the applicant may sit for the North American Pharmacist Licensing Examination (NAPLEX) and the Virginia examination of state and federal law. Once a passing score is achieved on these last two examinations, an applicant is licensed.  Reference: Law- §54.1-3312, Regulation- 18 VAC 110-20-30 through 70, Guidance Document 110-17

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Questions Related to Facility Licensing

Does the Board provide advice or review plans related to the construction of a new pharmacy or the remodeling of an existing pharmacy?

The Board does not give construction advice other than the requirements listed in regulations, nor does it review and approve plans. Application is required for any new pharmacy or for any remodeling or change of location of an existing pharmacy. Current regulations must be met in any new construction and the new construction must be inspected prior to stocking prescription drugs. Reference: Law- §54.1-3434 and Regulation- 18 VAC 110-20-110 through 200

How many days notice need to be given on closing of a pharmacy?

A pharmacy owner may provide notice to the public in one of two ways. A sign may be conspicuously posted at least 30 days prior to closing or a notice may be mailed to all active refill customers at least 14 days prior to closing. Such notice shall include the expected date of closing, and the name of the pharmacy to which prescriptions and other records will be transferred. In addition, a notice must be provided to the Board at least 14 days prior to closing giving the information provided to the public, an explanation as to how the public notice was given (if by mail, send in a copy of the notice showing date), and notification as to where drugs will be transferred. Reference: Law- §54.1-3434.01 and Regulation- 18 VAC 110-20-130

I need a copy of the Drug Control Act and the pharmacy regulations.

Both are available on this website under Laws and Regulations, or you can call the Board office at (804) 367-4456 and a paper copy will be mailed to you.  Reference: N/A

What is the earliest date that the Board will schedule an inspection once an application has been submitted for a new permit, a change of location or for the remodeling of a pharmacy?

Board regulation 18VAC110-20-140 states that applications submitted to the Board which indicate a requested inspection date, or requests which are received after the application is filed, shall be honored provided a 14-day notice is allowed prior to the requested inspection date. Occasionally, the inspectors may be able to accommodate an earlier date, but this is dependent on their previously scheduled obligations. Additionally, please note that if the applicant needs to reschedule a previously agreed upon inspection date due to construction delays, vacations, etc., then this may result in an additional delay of 14 days depending upon the inspectors' prior commitments.

Does an out-of-state supplier of medical equipment and supplies need a Virginia permit in order to be reimbursed by Medicaid?

Virginia law restricts the dispensing of prescription devices and oxygen, sterile water and saline, and hypodermic needles and syringes to either a permitted pharmacy or a permitted medical equipment supplier, therefore, the Department of Medical Assistance Services (DMAS) which administers the Medicaid program in Virginia usually requires proof of Virginia licensure in order for a company to be credentialed as a Medicaid provider. The application for a medical equipment supplier or for a non-resident pharmacy can be downloaded from the forms section of this web page.  Reference: Law- §§54.1-3401, 54.1-3434.1, and 54.1-3435.2

Does an out-of-state pharmacy need to be registered in Virginia in order to be reimbursed by Medicaid?

If the out-of-state pharmacy is shipping, mailing, or otherwise delivering prescription drugs into Virginia to Virginia residents, registration as a non-resident pharmacy is required. However, if the out-of-state pharmacy is not mailing, shipping, or delivering into Virginia and is only dispensing to Virginia residents who come into the pharmacy to have prescriptions filled, Virginia law does not require registration. The Department of Medical Assistance Services (DMAS) which administers the Medicaid program in Virginia may ask for documentation of Virginia registration as part of the credentialing process to be a Medicaid provider since is has no way of determining if a claim is the result of a mail-order prescription or a walk-in prescription. According to DMAS officials, in lieu of providing a non-resident pharmacy registration, an out-of-state pharmacy may certify to DMAS in writing that it is not a mail-order pharmacy and only fills "walk-in" prescriptions. Proximity of the pharmacy to the Virginia border may also be requested by DMAS.  Reference: Law- §54.1-3434.1

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Questions Related to Pharmacy Practice

If a pharmacist is not physically present in the prescription department (helping a patient, taking a break, etc.), does the prescription department have to be locked and alarmed?

No one can be present in the prescription department of a pharmacy, and that prescription department must be locked and alarmed, unless a pharmacist is on duty. The term "on duty" as defined in 18 VAC 110-20-10 means that a pharmacist is on the premises at the address of the permitted pharmacy and is available as needed. Further, 18 VAC 110-20-190 (C) provides the pharmacist on duty the discretion to at all times authorize persons to be present in the prescription department or to disallow any person to be in the prescription department.

Can a pharmacy set up an answering machine or voice-mail for prescribers and their authorized agents to leave oral prescriptions or refill authorizations?

Yes, the Board recently considered this issue and determined that an oral prescription may be left by a prescriber on a voice recording device or on voice mail provided the pharmacist personally takes the prescription information off the recorder or voice mail and transcribes the oral prescription to a written hard copy. Reference: Board Minutes, 6/11/98

Can a pharmacy return dispensed prescriptions from "will call" to stock if the patient never picks up the prescription?

The Board has established a guidance document that allows the restocking of drugs from will-call provided the pharmacy places an expiration date on the label which in the absence of stability data to the contrary, shall not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed, whichever date is earlier. The restocked drug should be used to fill the next prescription received for that product. In the event that the drug is not dispensed prior to the new assigned expiration date, it will be removed from stock and destroyed or otherwise disposed of in accordance with regulations. If there is no lot number on the label of a drug returned to stock or on the prescription records which can be cross referenced from the prescription label, the drug will be removed from stock upon any recall of that drug product and returned to the manufacturer or otherwise disposed of in accordance with regulations. Reference: Guidance Document 110-16

If a prescription is dispensed in multiple containers, for example at a parent's request to have an extra container to send to school, how must the prescription be labeled? May only the school instructions be placed on the school container?

All containers should be labeled with the same instructions and must reflect the prescriber's complete instructions. Reference: Minutes-June 10, 1997, §54.1-3410 (A)(3) and (B)(2), §54.1-3463 (A)

May a pharmacist administer a vaccine?

Yes. A pharmacist may administer vaccines to adults pursuant to a protocol approved by the Board of Nursing. A pharmacist may also dispense (to include administering) a vaccine, which is a Schedule VI controlled substance, pursuant to a prescription written by a prescriber for a specific patient.  Reference: §54.1-3408

What is a Board approved innovative (pilot) program?

As explained in §54.1-3307.2, any person who proposes to use a process or procedure related to the dispensing of drugs or devices or to the practice of pharmacy not specifically authorized by Chapter 33 (§ 54.1-3300 et seq.) of this title or by a regulation of the Board of Pharmacy may apply to the Board for approval to use such process or procedure. The submitted application may only contain suggested processes or procedures which are within the current scope of the practice of pharmacy, that relate to the form or format of prescriptions, the manner of transmitting prescriptions or prescription information, the manner of required recordkeeping, the use of unlicensed ancillary personnel in the dispensing process, and the use of new technologies in the dispensing process. An innovative (pilot) program shall not expand the current scope of practice of pharmacists. The Board may choose to deny the proposed program, approve the program as submitted, or approve the program based on specific terms and conditions. For more information regarding innovative (pilot) programs or for a copy of a Consent Order related to an innovative program, please contact the Board office directly. Reference: §54.1-3307.2 and 18VAC110-20-121

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Pharmacy Sudafed Log Guidance

Can a pharmacy use the paraphernalia log to record sales of ephedrine and pseudoephedrine as required by the new methamphetamine precursor order, or does this have to be a separate log?

No, this must be a separate log for the following reasons. The information required by the Virginia Department of Health order on the ephedrine/pseudoephedrine sales log is different from the information required on the paraphernalia log. The retention time for maintaining this log is one year and the paraphernalia log is two years. The disclosure of the ephedrine/pseudoephedrine log is to be made available to law enforcement personnel whereby the paraphernalia log would not be available to all law enforcement personnel but limited to designated state police agents.

 

 

Questions Related to Pharmacy Technician Registration

What are the prerequisites for being eligible for registration?

A pharmacy technician must either hold current certification from the Pharmacy Technician Certification Board (PTCB) or satisfactorily complete a Virginia Board of Pharmacy approved training program and pass a Board of Pharmacy approved examination. An applicant must also submit an application form with fee to the board for review.

Where can I get an application form?

Applications on our website on the applications and forms page or by contacting the board office at 804-367-4456.

What is the fee for registration?

A person who wishes to register as a pharmacy technician must submit a completed application and a $25 fee to the Board of Pharmacy. Checks are to be made payable to the “Treasurer of Virginia”. The application will usually be reviewed and verified, and processed within 7 to 10 business days. A pharmacy technician must maintain their registration in order to continue performing technician tasks. This requires a $25 annual renewal fee and the completion of 5 hours of pharmacy continuing education annually.

How do I know if the board has approved a training program?

Approved training programs may be identified by checking our website for a listing. Click on the “Technicians” link then on “List of Approved Pharmacy Technician Training Programs.” A person who has completed a training program prior to board approval need not retake the entire program after it is approved provided there have been no significant changes in the program or provided the person receives additional training on the portion that has been changed.

How do I request to take the PTCB test?

Information about applying to take the PTCB can be found at www.ptcb.org.

How do I sign up for the Virginia examination?

The Virginia Pharmacy Technician Exam can be scheduled by contacting LaserGrade at 1-800-211-2754 to register for the exam. A Study Guide for the exam can be downloaded from the www.nationaltechexam.org/va/ website.

Where and how often will the Virginia examination be offered?

Testing for the Virginia examination will be held at a LaserGrade Computer Testing, Inc. facility. There are currently 11 testing locations in Virginia offering exams six days a week during normal business hours; some offer exams on Sundays and some evenings as well. As a general rule, an exam will be scheduled within 10-14 days of receiving the application. The link on the Board of Pharmacy website will allow you to locate the testing facility closest to you.

What is the cost to take the PTCB or the Virginia examination?

Check the PTCB website for current fee information for their exam. As of July 1, 2008, the cost for the Virginia examination is $70.

Do persons newly hired to be pharmacy technicians have a “grace period” before they need to be registered with the Board of Pharmacy?

Provided a person is enrolled in an approved pharmacy technician training program, that person can work as a pharmacy technician for up to nine months while going through the process to become registered. After the nine months, registration is required in order to continue working as a pharmacy technician. Every pharmacy using such a person shall have documentation on site and available for inspection showing that the person is currently enrolled in an approved training program, and the start date for the training.

The pharmacist to technician ratio must be considered in this scenario. The new ratio is 1 pharmacist to 4 technicians. Of the 4 technicians only 2 may be “technicians in training” as described above.

May I work in a pharmacy as a technician if I plan to take the PTCB exam in the future?

Applying to take the PTCB is not considered to be enrollment in a Board approved training program. You may not work as a pharmacy technician unless you are registered or enrolled in a Board approved training program (see above). If you want to work while waiting to take the PTCB, you must be enrolled in an approved program.

What are the requirements for continuing education?

Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians

Registered Pharmacy Technicians are required to obtain a minimum of 5 contact hours of continuing pharmacy education (CPE) per calendar year in order to maintain an active registration. This brochure is intended to help pharmacy technicians to better understand the CPE requirements. The Board of Pharmacy prepared this document as a guide in order to promote compliance with the statutes and regulations concerning CPE.

Q. What is the minimum number of CPE hours required? When do I have to take them?

A. The law requires a minimum of 5 contact hours per calendar year. You should receive all your certificates prior to sending in the license renewal in order to properly attest that you have met the requirements. The certificates should be dated between January 1 and December 31, inclusive, of the calendar year they are used.

Q. May I carry over my extra hours to next year? What if I’m licensed in another state?

A. No. The law does not allow any carryover. Although some states permit courses to be taken over a two-year period, Virginia does not. This means a pharmacy technician registered in Virginia must obtain at least 5 CPE hours each and every calendar year.

Q. May I get an extension?

A. Yes. A one-time extension may be possible if the request is made in writing to the Board prior to renewal.

Q. I obtained my license in Virginia earlier this year. Do I need CPE credits now to renew my license for next year?

A. Yes.

Q. Do I have to obtain credits from any particular providers?

A. Yes. In order to meet the CPE requirements, courses must be either ACPE approved or certain Category 1 CME or a program approved by the Virginia Board of Pharmacy. Any credits taken that do not meet these requirements cannot be used to satisfy CPE hours.

Q. I’ve lost my certificates. What should I do?

A. You should obtain a replacement from the course provider. ACPE approved providers must keep this information for at least five years. Some providers make it possible to print duplicates from their web sites.

Q. Do I have to keep my certificates at work?

A. No. Pharmacy technicians must keep their original certificates at their address of record. Pharmacy technicians are encouraged to keep an extra copy elsewhere, as a precaution, in the event the originals cannot be located.

Q. I’ve taken a course near the end of the year and didn’t get my certificate until the next calendar year. How are the hours applied?

A. The date the certificate is issued controls unless it is a “live” course. Live courses are counted on the date of attending the course.

Q. What should I do if the Board audits me?

A. Whenever the Board may contact you, you should respond promptly. Failure to respond may cause the Board to pursue disciplinary action. If the Board audits your continuing pharmacy education credits, find your original certificates and make a copy for yourself. Send the originals to the Board office by the deadline in the letter. Although not required, you may want to send your response by certified mail so that you have proof of mailing. If you do not have enough credits for the year(s) in question, you may send an explanation to the Board with your certificates. Your explanation will be taken into account when the Board determines whether disciplinary action should be pursued. If you have lost some or all of your certificates, you should immediately contact the respective providers for a replacement certificate and inform the Board of your actions. Current Board guidelines call for a monetary penalty of $100 for each missing hour of CPE, and $300 for each renewal falsely attesting to CPE compliance.

Q. What can I do to keep my records better organized?

A. Here are some suggestions that may help you to keep your CPE records organized and avoid disciplinary action:

  1. 1. Store your original certificates in a safe place where they are unlikely to be thrown out by mistake.

  2. 2. Keep a copy of your certificates, or at least a record of the course number, provider and date, in a secondary safe location (not with the originals). These are a back-up if you lose the originals.

  3. 3. BEFORE YOU RENEW YOUR LICENSE, look at your original certificates and verify compliance with the CPE requirements:

  • 5 contact hours in pharmacy continuing education (some courses may carry a different number of credits for other professions)

  • ACPE approved (look for the logo), or Category 1 CME courses focused on pharmacy, pharmacology or drug therapy, or a program approved by the Virginia Board of Pharmacy

  • Each of your CPE certificates show a “date issued” on or prior to December 31 for the year in question.

Note that it is your responsibility to maintain your CPE records for the current and two previous calendar years. You must complete the hours before you send in the licensure renewal.

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Prescription Blank Requirements

In 2003, the General Assembly eliminated the Virginia Voluntary Formulary as the standard for generic substitution for several reasons, and put into place the FDA "Orange Book" as the new standard. For this reason, the prescription blank requirement for a check box "Voluntary Formulary Permitted" had to be removed from law. There is now no set form for a written prescription blank. Because the term "brand medically necessary" is a nationally accepted term and one that is required by Medicaid in order to ensure payment for a branded product, this phrase was adopted in Virginia law as the required term to prohibit generic substitution. The new law did give prescribers three years to use up all their "old" prescription blanks before the new requirement took effect. After July 1, 2006, checking an old "dispense as written" box will not prohibit generic substitution.

Below are some frequently asked questions on the subject:

Q. When ordering new prescription pads, should the prescriber remove the Dispense as Written and Virginia Voluntary Formulary boxes from new prescription pads?

A. Yes. After July 1, 2006, the Dispense as Written box will not prohibit substitution with a therapeutically equivalent drug, and the Virginia Voluntary Formulary is no longer recognized as the standard of therapeutic equivalence. The new standard is FDA's Orange Book which can be found on-line. http://www.fda.gov/cder/ob/default.htm

Q. Can the prescriber put the phrase” Brand Medically Necessary” in the form of a check-box on the prescription pad or "stamp" the phrase on the prescription?

A. Yes. The law does not state in what form the phrase should appear. However, the prescriber must handwrite the phrase in order to ensure payment for a branded product for Medicaid patients when there are generics available in the marketplace.

Q. Can prescribers continue to use and deplete their current stock of the old two-check-box formatted prescription blanks after July 1, 2006?

A. Yes. However, after this date, checking the "dispense as written" box will not prevent substitution. Prescribers will still need to indicate “Brand Medically Necessary” on the prescription when they do not want a generic dispensed.

Q. Does this law that allows a pharmacist to substitute a "therapeutically equivalent" drug mean that a pharmacist can substitute a different drug within a therapeutic class?

A. No. This law refers to what is commonly called generic substitution. The terminology used in the law is somewhat confusing, but the definition of "therapeutically equivalent drug product" in the law means a drug that contains the same active ingredient(s) identical in strength, concentration, and dosage form, and has been evaluated by FDA and deemed to be therapeutically equivalent to the brand name drug.

Q. Do prescriptions have to be written on special security paper to assist in preventing forgeries?

A. No. Virginia law does not require this at this time.

Q. What are other requirements for prescriptions?

A. See Board of Pharmacy, Guidance Document 110-35 (word .doc) available on the Board's website under guidance documents.

Statutes related to generic substitution requirements with relevant phrases bolded:
excerpt from §54.1-3401. Definitions
"Therapeutically equivalent drug products" means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the United States Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

§ 54.1-3408.03. Dispensing of therapeutically equivalent drug product permitted.

A. A pharmacist may dispense a therapeutically equivalent drug product for a prescription that is written for a brand-name drug product unless (i) the prescriber indicates such substitution is not authorized by specifying on the prescription, "brand medically necessary" or (ii) the patient insists on the dispensing of the brand-name drug product.

In the case of an oral prescription, the prescriber's oral dispensing instructions regarding substitution shall be followed.

B. Prescribers using prescription blanks printed in compliance with Virginia law in effect on June 30, 2003, having two check boxes and referencing the Virginia Voluntary Formulary, may indicate, until July 1, 2006, that substitution is not authorized by checking the "Dispense as Written" box. If the "Voluntary Formulary Permitted" box is checked on such prescription blanks or if neither box is checked, a pharmacist may dispense a therapeutically equivalent drug product pursuant to such prescriptions.

C. If the pharmacist dispenses a drug product other than the brand name prescribed, he shall so inform the purchaser and shall indicate, unless otherwise directed by the prescriber, on both his permanent record and the prescription label, the brand name or, in the case of a therapeutically equivalent drug product, the name of the manufacturer or the distributor. Whenever a pharmacist dispenses a therapeutically equivalent drug product pursuant to a prescription written for a brand-name product, the pharmacist shall label the drug with the name of the therapeutically equivalent drug product followed by the words "generic for" and the brand name of the drug for which the prescription was written.

D. When a pharmacist dispenses a drug product other than the drug product prescribed, the dispensed drug product shall be at a lower retail price than that of the drug product prescribed. Such retail price shall not exceed the usual and customary retail price charged by the pharmacist for the dispensed therapeutically equivalent drug product.


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