Virginia Regulatory Town Hall

Proposed Text

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Action:
Nonresident pharmacy renewal date and access by suspended ...
Stage: Fast-Track
 
18VAC110-20-20

18VAC110-20-20. Fees.

A. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Unless otherwise provided, any fees for taking required examinations shall be paid directly to the examination service as specified by the board.

C. Initial application fees.

1. Pharmacist license

$180

2. Pharmacy intern registration

$15

3. Pharmacy technician registration

$25

4. Pharmacy permit

$270

5. Permitted physician licensed to dispense drugs

$270

6. Medical equipment supplier permit

$180

7. Humane society permit

$20

8. Nonresident pharmacy

$270

9. Controlled substances registrations

$90

10. Innovative program approval.

If the board determines that a technical consultant is required in order to make a decision on approval, any consultant fee, not to exceed the actual cost, shall also be paid by the applicant in addition to the application fee.

$250

11. Approval of a pharmacy technician training program

$150

12. Approval of a continuing education program

$100

13. Approval of a repackaging training program

$50

D. Annual renewal fees.

1. Pharmacist active license – due no later than December 31

$90

2. Pharmacist inactive license – due no later than December 31

$45

3. Pharmacy technician registration – due no later than December 31

$25

4. Pharmacy permit – due no later than April 30

$270

5. Physician permit to practice pharmacy – due no later than February 28

$270

6. Medical equipment supplier permit – due no later than February 28

$180

7. Humane society permit – due no later than February 28

$20

8. Nonresident pharmacy – due no later than April 30 the date of initial registration

$270

9. Controlled substances registrations – due no later than February 28

$90

10. Innovative program continued approval based on board order not to exceed $200 per approval period.

 

11. Approval of a pharmacy technician training program

$75 every two years

12. Approval of a repackaging training program

$30 every two years

E. Late fees. The following late fees shall be paid in addition to the current renewal fee to renew an expired license within one year of the expiration date or within two years in the case of a pharmacy technician training program. In addition, engaging in activities requiring a license, permit, or registration after the expiration date of such license, permit, or registration shall be grounds for disciplinary action by the board.

1. Pharmacist license

$30

2. Pharmacist inactive license

$15

3. Pharmacy technician registration

$10

4. Pharmacy permit

$90

5. Physician permit to practice pharmacy

$90

6. Medical equipment supplier permit

$60

7. Humane society permit

$5

8. Nonresident pharmacy

$90

9. Controlled substances registrations

$30

10. Approval of a pharmacy technician training program

$15

11. Approval of a repackaging training program

$10

F. Reinstatement fees. Any person or entity attempting to renew a license, permit, or registration more than one year after the expiration date, or more than two years after the expiration date in the case of a pharmacy technician training program, shall submit an application for reinstatement with any required fees. Reinstatement is at the discretion of the board and, except for reinstatement following license revocation or suspension, may be granted by the executive director of the board upon completion of an application and payment of any required fees.

1. Pharmacist license

$210

2. Pharmacist license after revocation or suspension

$500

3. Pharmacy technician registration

$35

4. Pharmacy technician registration after revocation or suspension

$125

5. Facilities or entities that cease operation and wish to resume shall not be eligible for reinstatement but shall apply for a new permit or registration. Facilities or entities that failed to renew and continued to operate for more than one renewal cycle shall pay the current and all back renewal fees for the years in which they were operating plus the following reinstatement fees:

 

a. Pharmacy permit

$240

b. Physician permit to practice pharmacy

$240

c. Medical equipment supplier permit

$210

d. Humane society permit

$30

e. Nonresident pharmacy

$115

f. Controlled substances registration

$180

g. Approval of a pharmacy technician training program

$75

h. Approval of a repackaging training program

$50

G. Application for change or inspection fees for facilities or other entities.

1. Change of pharmacist-in-charge

$50

2. Change of ownership for any facility

$50

3. Inspection for remodeling or change of location for any facility

$150

4. Reinspection of any facility

$150

5. Board-required inspection for a robotic pharmacy system

$150

6. Board-required inspection of an innovative program location

$150

7. Change of pharmacist responsible for an approved innovative program

$25

H. Miscellaneous fees.

1. Duplicate wall certificate

$25

2. Returned check

$35

18VAC110-20-190

18VAC110-20-190. Prescription department enclosures; access to prescription department.

A. The prescription department of each pharmacy shall be provided with enclosures subject to the following conditions:

1. The enclosure shall be constructed in such a manner that it protects the prescription drugs from unauthorized entry and from pilferage at all times whether or not a pharmacist is on duty.

2. The enclosure shall be locked and alarmed at all times when a pharmacist is not on duty.

3. The enclosure shall be capable of being locked in a secure manner at any time the pharmacist on duty is not present in the prescription department.

B. The keys or other means of entry into a locked prescription department and the alarm access code shall be restricted to pharmacists practicing at the pharmacy and authorized by the PIC with the following exceptions:

1. The PIC or a pharmacist on duty, for emergency access, may place a key or other means of unlocking the prescription department and the alarm access code in a sealed envelope or other container with the pharmacist's signature across the seal in a safe or vault or other secured place within the pharmacy. This means of emergency access shall only be used to allow entrance to the prescription department by other pharmacists, or by a pharmacy technician in accordance with subsection D of this section. In lieu of the pharmacist's signature across a seal, the executive director for the board may approve other methods of securing the emergency access to the prescription department.

2. Pharmacy interns, pharmacy technicians, and other persons authorized by the PIC or pharmacist on duty may possess a key or other means of entry into a locked prescription department only when a pharmacist is on duty. Such key or other means of entry shall not allow entry when a pharmacist is not on duty.

C. The prescription department is restricted to pharmacists who are practicing at the pharmacy. Pharmacy interns, pharmacy technicians, and other persons designated by the pharmacist on duty may be allowed access by the pharmacist but only when the pharmacist is on duty. Each pharmacist while on duty shall be responsible for the security of the pharmacy, including provisions for effective control against theft or diversion of prescription drugs and devices.

D. A PIC or pharmacist on duty shall not permit access to the prescription department or controlled substances by a pharmacist, pharmacy intern, or pharmacy technician whose license or registration is currently suspended or revoked.

D. E. Upon a request by a patient to obtain an already-dispensed prescription, a pharmacy technician may enter the pharmacy for the sole purpose of retrieving filled prescriptions that have already been reviewed and certified for accuracy by a pharmacist and deemed ready for delivery to the patient if:

1. There is an unforeseen, unplanned absence of a pharmacist scheduled to work during regular prescription department hours;

2. Alternate pharmacist coverage cannot immediately be obtained;

3. The technician is accompanied by a member of the pharmacy's management or administration; and

4. All requirements of subsection E F of this section are met.

E. F. Requirements for entry into the prescription department in the absence of a pharmacist.

1. The requirements for prescriptions awaiting delivery in subsection A of 18VAC110-20-200 are followed.

2. Prior to entry into the prescription department, the pharmacy technician shall obtain verbal permission from the PIC or another pharmacist regularly employed by that pharmacy to obtain and use the emergency key or other access and alarm access code and enter the pharmacy.

3. A record shall be made by the pharmacy technician of the entry to include the date and time of entry; the name and signature of the pharmacy technician; the name, title, and signature of the person accompanying the pharmacy technician; the pharmacist's name granting permission to enter and telephone number where the pharmacist was reached; the name of the patient initially requesting needed medication and the nature of the emergency; a listing of all prescriptions retrieved during that entry; and the time of exit and re-securing of the prescription department.

4. The pharmacy technician shall reseal the key and alarm access code after the pharmacy is re-secured, and the PIC shall have the alarm access code changed within 48 hours of such an entry and shall document that this has been accomplished on the record of entry.

5. All records related to entry by a pharmacy technician shall be maintained for a period of one year on premises.