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 email@example.com.
Questions Related to
Questions Related to Facility Licensing
Questions Related to Pharmacy Practice
Questions Related to Pharmacy Technician Registration
Questions Related to Physicians Dispensing Drugs Licensing and Practice
Questions Related to Prescription Blank Changes
Questions Related to New Inspection Process
Where may an individual having completed an ACPE-approved school of pharmacy find information on how to obtain a pharmacist license in Virginia?
Please refer to Guidance Document 110-2 for information on obtaining a pharmacist license by examination, or by reciprocity from another state, also called "licensure by endorsement" or "license transfer".
What are the requirements for a graduate of a foreign school of pharmacy to become licensed in Virginia?
Please refer to Guidance Document 110-17 for more complete information on eligibility for a graduate of a foreign college of pharmacy to become licensed as a pharmacist in Virginia. Prior to application as a pharmacy intern for the purpose of obtaining practical experience and prior to application for a pharmacist license, a graduate of a foreign school of pharmacy must first complete the Foreign Pharmacy Graduate Equivalency Committee certification process (FPGEC), which includes an education equivalency review and approval, passage of the FPGEE and a passing score on the TOEFL-iBT, or both the TOEFL and TSE. More information on this process is on the National Association of Boards of Pharmacy website at www.nabp.net
The Virginia Board of Pharmacy has no authority to waive the requirements for the FPGEC and does not approve any alternative educational credentials or alternative tests. Please do not contact the Board to request an exception to the FPGEC requirements.
Does Virginia require the FPGEC for graduates of Canadian colleges of pharmacy?
In accordance with the ACPE recognition of accreditation by the Canadian Council for Accreditation of Pharmacy Programs (CCAPP), with respect to professional programs leading to the baccalaureate degree in pharmacy for the time period since the establishment of CCAPP in 1993 through June 30, 2004, Virginia will also deem these programs equivalent and not require the FPGEC for those persons graduating from a CCAPP accredited college of pharmacy during this time period only. Persons graduating prior to 1993 or after June 30, 2004 must obtain the FPGEC.
Does Virginia require the tests of written and spoken English for applicants from foreign colleges of pharmacy where English is the primary language in that country, such as the United Kingdom and parts of Canada?
The Board has no authority to waive the requirements for the tests of English for those persons graduating from a foreign college of pharmacy even if English is the primary language.
How does a pharmacist currently licensed in another state reciprocate his license to Virginia?
A pharmacist must first complete the licensure transfer application process through the National Association of Boards of Pharmacy (NABP) by visiting www.nabp.net.A review of his educational credentials and licensure status, to include any possible disciplinary action, will be performed to ensure compliance with Virginia's requirements. Once this application to NABP has been approved, NABP will provide the pharmacist with a partially-completed NABP Official Application For Transfer of Pharmacist License to the state of Virginia. The pharmacist must then fully complete this application and submit it to the Virginia Board of Pharmacy. Once the Board reviews and approves this application, provided no grounds exist to deny the license, the Board will notify the pharmacist of his eligibility to sit for the Virginia Federal and State Drug Law Examination (FSDLE). Virginia does not participate in the Multistate Pharmacy Jurisprudence Examination (MPJE).
More information regarding this process may be found in Guidance Document 110-2. Additionally, the study guide for the Virginia Federal and State Drug Law Examination (FSDLE) should be carefully reviewed, along with the laws and regulations specified in the guide before attempting to take this examination. Many applicants have found the examination difficult to pass without studying. An applicant should not rely on his assumed knowledge of pharmacy law to pass this examination, especially if practicing in another state, as state laws may differ significantly.
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.
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.
How many practical experience hours are required in Virginia prior to applying for a license?
An applicant for licensure as a pharmacist shall attain a minimum of 1,500 hours of practical experience. Practical experience that is gained within an ACPE-accredited school of pharmacy, that conforms to the current ACPE standards, and that allows the student to gain at least 1,500 hours of practical experience, shall meet the board's practical experience requirements for licensure as a pharmacist. Virginia no longer requires 300 hours of the 1,500 hours of the practical experience to be gained outside the college of pharmacy experiential program. Reference: Regulation 18VAC110-20-30
How does an applicant register for the Virginia Federal and State Drug Law Examination (FSDLE)?
Once an applicant has been notified by the Board that he is eligible to sit for the Virginia Federal and State Drug Law Examination (FSDLE), he may register and find a preferred testing center location by visiting Iso-Quality Testing’s (IQT) website at www.isoqualitytesting.com or by calling their toll free number 866-773-1114. At the time of registration he will be asked a series of questions:
- When – The day and time he wishes to take the exam.
- Where – The location of the Testing Center.
- Payment – He may be able to pay the $112 Testing Fee with a personal credit card over the phone or he may contact Iso-Quality Testing for other means of payment.
- Full Legal Name – His official name on record given to the Virginia Board of Pharmacy.
- Social Security number or Virginia DMV control number – This is his personal identification number that will be used by both the Virginia Board of Pharmacy and Iso- Quality Testing.
More specific information regarding the registration process for this exam may be found in the Study Guide (Examination Handbook) for Virginia Federal and State Drug Law Exam (Word .doc)
Does an applicant have to travel to Virginia to take the Federal and State Drug Law Examination (FSDLE)?
No. This computer-based examination is administered at testing sites throughout the United States. Please visit Iso-Quality Testing’s (IQT) website at www.isoqualitytesting.com or call their toll free number 866-773-1114 to find a preferred testing center location.
Are there sample questions or a preparatory class offered for the Virginia Federal and State Drug Law Examination (FSDLE)?
No. However, applicants are strongly encouraged to use the Study Guide (Examination Handbook) for Virginia Federal and State Drug Law Exam (Word .doc) as a study guide when preparing to take this exam.
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 amount of CE that would have been required during that time period up to a maximum of 60 hours total. However, the hours 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. One problem with inactive status, is that pharmacists who have been inactive for more than 5 years, and then want to reactivate, must take and pass the Virginia pharmacy law examination again, and if they cannot provide documentation that they have been practicing in another jurisdiction, must also perform 160 hours as a pharmacy intern in order to be eligible to reactivate.
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 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
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?
Yes. Regulation 18VAC110-20-355 D 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 shall 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: Regulation 18VAC110-20-355
What changes does DEA allow a pharmacist to make to a prescription written for a CII controlled substance?
See Board Guidance Document 110-41 and the following link to DEA's website: http://www.deadiversion.usdoj.gov/faq/general.htm#rx-7
What changes does DEA allow a pharmacist to make to a prescription written for a CIII-V controlled substance?
Refer to DEA's website: http://www.deadiversion.usdoj.gov/faq/general.htm#rx-8
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. Additionally, a pharmacist may administer influenza vaccine to minors when acting in accordance with guidelines developed pursuant to § 32.1-46.02. Pharmacists 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 of any age. Reference: §54.1-3408 and §54.1-3401
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 record keeping, 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
What are the prerequisites for being eligible for registration?
There are two methods for obtaining registration as a pharmacy technician. Either of the following methods is acceptable.
- If an individual holds current certification from the Pharmacy Technician Certification Board (PTCB), then he may submit the online Application for Registration as a Pharmacy Technician to the Board for review. Information regarding obtaining certification from PTCB may be accessed at www.ptcb.org and the Board’s online application may be accessed at www.license.dhp.virginia.gov/apply/.
- An individual must satisfactorily complete a Virginia Board of Pharmacy approved training program, pass a Board of Pharmacy approved examination, and then submit the online Application for Registration as a Pharmacy Technician to the Board for review. There are many Board approved pharmacy technician training programs from which to choose. A complete list may be found by here. Additionally, there are currently two Board approved examinations. An individual may either take and pass the Virginia Pharmacy Technician Exam or the ExCPT exam. Information for the Virginia Pharmacy Technician Exam may be accessed at www.smttest.com/vapt and information for the ExCPT exam may be accessed at www.nationaltechexam.org
Where can I get an application form?
The paper application for registration as a pharmacy technician has been replaced with an online application. The online application may be accessed on our website at www.license.dhp.virginia.gov/apply/.
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 sign up for the Virginia examination?
Visit the SMT (current exam vendor) website at http://www.smttest.com/vapt to locate a testing site near you and make a test reservation.
Where may I learn more about the Virginia Pharmacy Technician exam?
Visit the SMT (current exam vendor) website at http://www.smttest.com/vapt for complete information regarding testing sites, test reservations, frequently asked questions specific to this exam, study guide, self-assessment questions, and more.
Where may I learn more on how to register for the ExCPT exam?
For complete information regarding the ExCPT exam, please visit the ICPT website at www.nationaltechexam.org.
How do I request to take the PTCB test?
Information about applying to take the PTCB can be found at www.ptcb.org.
What is the cost for taking the Virginia Pharmacy Technician Examination, ExCPT examination, and PTCB examination?
As of January 1, 2009, the cost for the Virginia examination is $70.25. Current fee information for the ExCPT examination and PTCB examination may be obtained from visiting their websites at www.nationaltechexam.org and www.ptcb.org, respectively.
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. Reference: Regulation 18VAC110-20-111
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 contacts 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 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. The Board has approved standard sanctions for CE non-compliance which can be found in guidance document 110-42.
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:
Store your original certificates in a safe place where they are unlikely to be thrown out by mistake.
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.
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.
Where may a physician learn more information regarding licenses issued to physicians for dispensing drugs?
Refer to guidance document 110-29 of the Virginia Board of Pharmacy entitled “Physicians Dispensing Drugs” for specific reference to the statutes and regulations governing this practice. www.dhp.virginia.gov/Pharmacy/pharmacy_guidelines.htm
If a physician wishes to dispense a drug that is also available in the local pharmacy, does the physician need to obtain a license from the Board of Pharmacy to dispense?
Yes, the physician must obtain from the Board of Pharmacy a license to dispense. There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. The more commonly issued license is the “practitioners of the healing arts to sell controlled substances” license and it authorizes a physician to dispense drugs to his own patients only.
Is a cosmetic prescription drug considered a controlled substance?
Yes. The term “controlled substance” as defined in 54.1-3401 of the Drug Control Act includes all prescription drugs.
Does a physician wanting to dispense drugs from multiple offices need to obtain a dispensing license at each location?
No. The physician must only obtain one dispensing license and he may dispense from any Board-approved selling location.
A physician wishing to dispense drugs has an office in Town A and in Town B. Neither office has been inspected and approved by the Board of Pharmacy as an approved selling location. What must the physician do to obtain authorization to dispense drugs to his own patients in both Town A and Town B?
The physician must submit to the Board of Pharmacy the “Application for a License for a Practitioner of the Healing Arts to Sell Controlled Substances” found at http://www.dhp.virginia.gov/pharmacy/pharmacy_forms.htm#Physicians, designating the Town A address on the application. A check or money order made payable to the “Treasurer of Virginia” for $240 must accompany the application. A second application designating the Town B address must also be submitted to authorize dispensing at the Town B location. The fee for inspecting and approving this second location is $150. An inspector of the Department of Health Professions must perform an initial inspection of each location and approve each location prior to the physician being authorized to dispense drugs from either location. Inspectors require 14 days from the date of receipt of the complete application to schedule the inspection date.
A physician practices in a group of five physicians: Physicians A, B, C, D, and E. Only Physician A has obtained from the Board of Pharmacy a license to dispense. Are Physicians B, C, D, and E permitted to dispense relying on Physician A’s license?
No. Each physician must obtain his own license to dispense. The license authorizes the physician to dispense but does not authorize another physician to dispense for or in the absence of that physician.
What is a limited-use license?
Pursuant to Regulation 18VAC110-30-20 and the delegation of authority to the Executive Director as set forth in Bylaws of the Board, a physician may apply for a limited-use license, when the scope, degree or type of services provided to the patient is of a limited nature. Under a limited-use license, a waiver of the square footage requirement for the controlled substances selling and storage area may be provided. Additionally, a waiver of the security system may be provided when storing and selling multiple strengths and formulations of no more than five different topical Schedule VI drugs intended for cosmetic use.
Physician A has decided to file an application for a practitioner of the healing arts to sell controlled substances license to dispense cosmetic drugs. Physician A wishes to seek a waiver for the requirements for an alarm system and the minimum square footage requirement. What is the recommended course of action?
It is recommended that the physician complete the application for licensure. Additionally, it is recommended that the physician file a waiver request with the Board of Pharmacy regarding the security system and storage area at the time the application is filed. An inspector of the Department of Health Professions will come to the physician’s office to conduct an initial inspection. No drugs may be dispensed until the Board has issued the license.
Physician A files an application with the Board of Pharmacy for a license to dispense. Physician A does not have a security system or the required square footage. Physician A forgets to file the request for waiver. An inspector from the Board of Pharmacy appears at the physician’s office. The physician tells the inspector that he intends to file for a waiver at some point in the future. Will the physician be granted a license to dispense?
No. The inspector will cite the deficiency of the security system and the required square footage. The physician must then submit a written response within 14 days of the inspection to the Board office indicating the corrective action taken or a request to have the applicable regulatory requirements waived.
Physician A practices with a nurse practitioner and a physician assistant. Physician A has obtained a dispensing license from the Board of Pharmacy. Is the nurse practitioner or physician assistant permitted to dispense under that license?
No, only the licensed physician may dispense drugs. The physician assistant or nurse practitioner may not dispense drugs.
Physician A arrives at the office and provides his nurse, trained in assisting him in dispensing, with a key to access the approved drug selling area where cosmetic drugs are stored. Physician A completes his work for the day and tells his nurse that he is leaving the office and will not be back for a week. May the registered nurse keep the key in case access to the drug selling area is needed while the physician is absent?
No. Nurses, office managers, physician assistants, and other office personnel may not have access to the approved drug selling area while the physician is not present on site.
Physician A has a cabinet in his private office that is secured with a lock and key. Physician A is the only person who has access to the cabinet. Would this example of a secured area be appropriate?
Yes. The selling and storage area may be in an office that is exclusively used by the licensee and to which only the licensee has access provided the portion of the office used exclusively for controlled substances storage and preparation is at least 60 square feet; provided the drugs are stored in a cabinet, closet or other lockable area which can be locked when the practitioner is using the office for purposes other than dispensing; and provided the office meets all other requirements of 18VAC110-30-90, 18VAC110-30-120, and 18VAC110-30-130.
Physician A maintains a current active dispensing license and dispenses a drug to Patient Jones in the examination room. Does the drug have to be labeled with the patient’s name and address?
Yes. A drug dispensed by a physician under a dispensing license should leave the physician’s office with a label containing the following minimal information:
- The name and address of the practitioner and the name of the patient;
- The date of the dispensing;
- The drug name and strength, when strength is applicable:
a. For any drug product possessing a single active ingredient, the generic name of the drug shall be included on the label.
b. If a generic drug is dispensed when a prescription is written for a brand name drug, the label shall contain the generic name followed by the words "generic for" followed by the brand name of the drug prescribed, and the label shall also contain the generic's brand name or the manufacturer or distributor of the drug dispensed; and
- The number of dosage units or, if liquid, the number of millimeters dispensed.
Physician A must post a sign informing patients of their right to their right to choose where they have their prescriptions filled. If the physician posts a sign only at the registration desk in view of the public is that sufficient?
No. A sign must be conspicuously displayed in the public area of the office, such as the registration desk, and in each patient examination room advising patients of their right to choose where they have their prescriptions filled.
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. 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
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.
Tamper-Resistant Prescription Pads: Effective April 1, 2008, certain outpatient written prescriptions are required to be on tamper-resistant prescription pads. This includes enrollees of Medicaid, MEDALLION, FAMIS, and FAMIS Plus fee-for-service, and "dual eligibles" when Medicare Part D is the primary payor and Medicaid the secondary. This is the result of a federal law passed last year that affects certain prescriptions paid for by the Centers for Medicare and Medicaid Services (CMS). This is not a Board of Pharmacy initiative or requirement. Prescribers and pharmacists may find information about this new requirement from these two websites:
When will the Board begin using this new inspection process?
The Board began piloting the new inspection process in community pharmacies in February 2010 and in hospital/compounding pharmacies in July 2010. As of July 1, 2011, the new inspection process will be live in all pharmacies.
How can a pharmacist prepare for a pharmacy inspection?
While not required, it is strongly suggested that each pharmacy perform a self-inspection using the applicable sections of the inspection report (pdf file). Performing a self-inspection will assist the pharmacist-in-charge in identifying possible areas of noncompliance that need correcting. Additionally, the creation of a notebook or folder containing all required inventories, along with information indicating the location of all required documents for an inspector to review, is essential in ensuring that all staff, including floater staff who may be on duty at the time of an unannounced inspection, know where to locate required documents. This level of organization will decrease the citing of unnecessary deficiencies, for example, citing a deficiency for not performing and maintaining a biennial inventory when in reality the inventory had been performed, but could not be located during the inspection.
What documents will the pharmacist receive at the conclusion of the routine inspection?
The inspector will provide the pharmacist-in-charge or pharmacist on-duty with an inspection summary which may be maintained in the pharmacy records. If no deficiencies were found, then this will be indicated on the summary. If deficiencies were identified, then it will state the inspector's observations regarding the cited deficiencies. If the cited deficiencies warrant a monetary penalty, then the inspector will also leave the pharmacist a modified consent order. This legal document will offer the pharmacy permit holder options for resolution of the inspection deficiencies which may require signing and returning this document to the Board office. It will then become a public document and therefore, this document should be kept clean at all times.
What should the pharmacist do if he disagrees with the inspector's findings?
If the pharmacy permit holder does not agree with the inspector's findings, then he may contact the Board office within 14 days to submit documentation contesting the inspector's findings, or within 30 days, he may request, in writing, an informal conference to further discuss this matter before a committee of the Board.
May the pharmacy be subject to additional monetary penalties if it requests an informal conference?
It is possible that a pharmacy may be subject to lesser or greater monetary penalties during an informal conference should additional findings warrant these changes.
How much are the monetary penalties?
The Board identified a list of egregious or “major” deficiencies that independently warrant a monetary penalty if cited. Additionally, the Board identified many “minor” deficiencies that alone do not warrant a monetary penalty; however, if three of these minor deficiencies are cited during a routine inspection, then a $250 monetary penalty will be imposed. For each additional minor deficiency after the original three, another $100 penalty will be added. The list of major and minor deficiencies, and associated monetary penalties, is found in Guidance Document 110-9.
Will the pharmacist on-duty have to pay the inspector the monetary penalties at the conclusion of the inspection?
No. The pharmacy permit holder must submit payment, along with the signed consent order, to the Board office for any monetary penalties within 30 days from the date of inspection.
Was this new inspection process created to generate revenue for the Board of Pharmacy?
No. The new inspection process was created to expedite the disciplinary process resulting from routine inspections and decrease travel costs associated with requiring Board members to attend informal conferences to resolve disciplinary cases associated with inspections. Additionally, the law requires that all monetary penalties imposed by the Board must be transferred to the Literary Fund of Virginia and cannot remain with the Virginia Board of Pharmacy.
During the testing phase of this new inspection process, what deficiencies, as listed in guidance document 110-9, were identified in various pharmacies?
- Major 8, "Refrigerator/freezer temperature out of range greater than +/- 4 degrees". A refrigerator is required to be maintained thermostatically between 2° and 8°C (36° and 46°F). A freezer is required to be maintained thermostatically between -20° and -10°C (-4° and 14°F).- In addition, to the $100 monetary penalty, drugs may be embargoed if they are not appropriately stored.
- Minor 5, "No thermometer or non-functioning thermometer in refrigerator/freezer, but within range, +/-4 degrees". Compliance will be determined by the inspector's calibrated thermometer.
- Major 20, "Pharmacist not checking and documenting repackaging, compounding, or bulk packaging". Specifically, the bin filling record for the automated counting device did not include the pharmacist’s initials verifying the accuracy of the process at the time the bin is refilled by a pharmacy technician.
- Major 14, "No incoming change of PIC inventory taken within 5 days".
- Minor 13, "Unable to locate invoices for Schedule VI drugs".
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