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CSB Repackaging- DRAFT 3/9/10 (BOP)


CSB Repackaging- DRAFT_3_9_2010.doc (DOC — 76 KB)               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$1802. Pharmacy intern registration$153. Pharmacy technician registration$254. Pharmacy permit$2705. Permitted physician licensed to dispense drugs$2706. Medical equipment supplier permit$1807. Humane society permit$208. Nonresident pharmacy$2709. Controlled substances registrations $9010. 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.$25011. Approval of a pharmacy technician training program$15012. Approval of a continuing education program$10013. Approval of a repackaging training program$50   D. Annual renewal fees.   1. Pharmacist active license$902. Pharmacist inactive license$453. Pharmacy technician registration$254. Pharmacy permit$2705. Physician permit to practice pharmacy$2706. Medical equipment supplier permit$1807. Humane society permit$208. Nonresident pharmacy$2709. Controlled substances registrations$9010. 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 years12. 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$302. Pharmacist inactive license$153. Pharmacy technician registration$104. Pharmacy permit$905. Physician permit to practice pharmacy$906. Medical equipment supplier permit$607. Humane society permit$58. Nonresident pharmacy$909. Controlled substances registrations$3010. Approval of a pharmacy technician training program$1511. 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$2102. Pharmacist license after revocation or suspension$5003. Pharmacy technician registration$354. Pharmacy technician registration after revocation or suspension$1255. 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$240b. Physician permit to practice pharmacy$240c. Medical equipment supplier permit$210d. Humane society permit$30e. Nonresident pharmacy$115f. Controlled substances registration$180g. Approval of a pharmacy technician training program$75h. 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$502. Change of ownership for any facility$503. Inspection for remodeling or change of location for any facility1504. Reinspection of any facility$1505. Board-required inspection for a robotic pharmacy system$1506. Board-required inspection of an innovative program location$1507. Change of pharmacist responsible for an approved innovative program$25     H. Miscellaneous fees.   1. Duplicate wall certificate$252. Returned check$35 I. For the annual renewal due on the stated dates, the following fees shall be imposed for a license, permit or registration: 1. Pharmacist active license – December 31, 2009$502. Pharmacist inactive license – December 31, 2009$253. Pharmacy technician registration – December 31, 2009$154. Pharmacy permit – April 30, 2010$2105. Physician permit to practice pharmacy – February 28, 2010$2106. Medical equipment supplier permit – February 28, 2010$1407. Humane society permit – February 28, 2010$208. Nonresident pharmacy – April 30, 2010$2109. Controlled substances registrations – February 28, 2010$50 18VAC110-20-275. Delivery of dispensed prescriptions. A. Pursuant to §54.1-3420.2 B of the Code of Virginia, in addition to direct hand delivery to a patient or patient's agent or delivery to a patient's residence, a pharmacy may deliver A dispensed prescription drug order for Schedule VI  controlled substances to another pharmacy, to a practitioner of the healing arts licensed to practice pharmacy or to sell controlled substances, or to an authorized person or entity holding a controlled substances registration issued for this purpose in compliance with this section and any other applicable state or federal law. Prescription drug orders for Schedule II through Schedule V controlled substances may not be delivered to an alternate delivery location unless such delivery is authorized by federal law and regulations of the board. B. Delivery to another pharmacy. 1. One pharmacy may fill prescriptions and deliver the prescriptions to a second pharmacy for patient pickup or direct delivery to the patient provided the two pharmacies have the same owner, or have a written contract or agreement specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which each pharmacy will comply with all applicable federal and state law. 2. Each pharmacy using such a drug delivery system shall maintain and comply with all procedures in a current policy and procedure manual that includes the following information: a. A description of how each pharmacy will comply with all applicable federal and state law; b. The procedure for maintaining required, retrievable dispensing records to include which pharmacy maintains the hard-copy prescription, which pharmacy maintains the active prescription record for refilling purposes, how each pharmacy will access prescription information necessary to carry out its assigned responsibilities, method of recordkeeping for identifying the pharmacist or pharmacists responsible for dispensing the prescription and counseling the patient, and how and where this information can be accessed upon request by the board; c. The procedure for tracking the prescription during each stage of the filling, dispensing, and delivery process; d. The procedure for identifying on the prescription label all pharmacies involved in filling and dispensing the prescription; e. The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information; f. The policy and procedure for ensuring accuracy and accountability in the delivery process; g. The procedure and recordkeeping for returning to the initiating pharmacy any prescriptions that are not delivered to the patient; and h. The procedure for informing the patient and obtaining consent for using such a dispensing and delivery process. 3. Drugs waiting to be picked up at or delivered from the second pharmacy shall be stored in accordance with subsection A of 18VAC110-20-200. C. Delivery to a practitioner of the healing arts licensed by the board to practice pharmacy or to sell controlled substances or other authorized person or entity holding a controlled substances registration authorized for this purpose. 1. A prescription may be delivered by a pharmacy to the office of such a practitioner or other authorized person provided there is a written contract or agreement between the two parties describing the procedures for such a delivery system and the responsibilities of each party.  2. Each pharmacy using this delivery system shall maintain a policy and procedure manual that includes the following information: a. Procedure for tracking and assuring security, accountability, integrity, and accuracy of delivery for the dispensed prescription from the time it leaves the pharmacy until it is handed to the patient or agent of the patient; b. Procedure for providing counseling; c. Procedure and recordkeeping for return of any prescription medications not delivered to the patient; d. The procedure for assuring confidentiality of patient information; and e. The procedure for informing the patient and obtaining consent for using such a delivery process. 3. Prescriptions waiting to be picked up by a patient at the alternate site shall be stored in a lockable room or lockable cabinet, cart, or other device which cannot be easily moved and which shall be locked at all times when not in use.  Access shall be restricted to the licensed practitioner of the healing arts or the responsible party listed on the application for the controlled substances registration, or other person as authorized in 18VAC110-20-700 C. D. The contracts or agreements and the policy and procedure manuals required by this section for alternate delivery shall be maintained both at the originating pharmacy as well as the alternate delivery site. E. A controlled substances registration as an alternate delivery site shall only be issued to an entity without a prescriber or pharmacist present at all times the site is open if there is a valid patient health or safety reason not to deliver dispensed prescriptions directly to the patient and if compliance with all requirements for security, policies, and procedures can be reasonably assured.   Part XVI. Controlled Substances Registration for Other Persons or Entities   18VAC110-20-685. Definitions.   For purposes of this part, the following definitions shall apply.   "CSB" means a community services board facility licensed by the Department of Behavioral Health and Developmental Services that holds a controlled substances registration issued by the Board.    "BHA" means a behavioral health authority facility licensed by the Department of Behavioral Health and Developmental Services that holds a controlled substances registration issued by the Board.  A. A person or entity which maintains or intends to maintain a supply of Schedule II through Schedule VI controlled substances, other than manufacturers' samples, in accordance with provisions of the Drug Control Act (§54.1-3400 et seq. of the Code of Virginia) may apply for a controlled substances registration on forms approved by the board. B. Persons or entities which may be registered by the board shall include, but not be limited to, hospitals without in-house pharmacies, nursing homes without in-house pharmacies that use automated drug dispensing systems, ambulatory surgery centers, outpatient clinics, alternative delivery sites, crisis stabilization units, and emergency medical services agencies provided such persons or entities are otherwise authorized by law and hold required licenses or appropriate credentials to administer the drugs for which the registration is being sought. C. In determining whether to register an applicant, the board shall consider factors listed in subsections A and D of §54.1-3423 of the Code of Virginia and compliance with applicable requirements of this chapter. 1. The proposed location shall be inspected by an authorized agent of the board prior to issuance of a controlled substances registration. 2. Controlled substances registration applications that indicate a requested inspection date, or requests that are received after the application is filed, shall be honored provided a 14-day notice is allowed prior to the requested inspection date. 3. Requested inspection dates that do not allow a 14-day notice to the board may be adjusted by the board to provide 14 days for the scheduling of the inspection. 4. Any person wishing to change an approved location of the drug stock, make structural changes to an existing approved drug storage location, or make changes to a previously approved security system shall file an application with the board and be inspected consistent with subsection B of this section. 5. Drugs shall not be stocked within the proposed drug storage location or moved to a new location until approval is granted by the board. D. The application shall be signed by a person who will act as a responsible party for the controlled substances. The responsible party may be a prescriber, nurse, pharmacist, or pharmacy technician for alternate delivery sites,or other person approved by the board who is authorized to administer controlled substances . E. The board may require a person or entity to obtain a controlled substances registration upon a determination that Schedule II through VI controlled substances have been obtained and are being used as common stock by multiple practitioners and that one or more of the following factors exist: 1. A federal, state, or local government agency has reported that the person or entity has made large purchases of controlled substances in comparison with other persons or entities in the same classification or category. 2. The person or entity has experienced a diversion, theft, or other unusual loss of controlled substances which requires reporting pursuant to §54.1-3404 of the Drug Control Act. 3. The person or entity has failed to comply with recordkeeping requirements for controlled substances. 4. The person or entity or any other person with access to the common stock has violated any provision of federal, state, or local law or regulation relating to controlled substances. A. A practitioner licensed in Virginia shall provide supervision for all aspects of practice related to the maintenance and use of controlled substances as follows: 1. In a hospital or nursing home without an in-house pharmacy, a pharmacist shall supervise. 2. In an emergency medical services agency, the operational medical director shall supervise. 3. For any other type of applicant or registrant, a pharmacist or a prescriber whose scope of practice is consistent with the practice of the applicant or registrant and who is approved by the board may provide the required supervision. B. The supervising practitioner shall approve the list of drugs which may be ordered by the holder of the controlled substances registration; possession of controlled substances by the entity shall be limited to such approved drugs. The list of drugs approved by the supervising practitioner shall be maintained at the address listed on the controlled substances registration. C. Access to the controlled substances shall be limited to the supervising practitioner or to those persons who are authorized by the supervising practitioner and who areauthorized by law to administer drugs in Virginia, or to such other persons who have successfully completed a training program for repackaging of prescription drug orders in a CSB or BHA as authorized in § 54.1-3420.2, or to other such persons as designated by the supervising practitioner or the responsible party to have access in an emergency situation. If approved by the supervising practitioner, pharmacy technicians may have access for the purpose of delivering controlled substances to the registrant, stocking controlled substances in automated dispensing devices, conducting inventories, audits and other recordkeeping requirements, overseeing delivery of dispensed prescriptions at an alternate delivery site, and repackaging of prescription drug orders retained by a CSB or BHA as authorized in § 54.1-3420.2.  Access to stock drugs in a crisis stabilization unit shall be limited to prescribers, nurses, or pharmacists.  D. The supervising practitioner shall establish procedures for and provide training as necessary to ensure compliance with all requirements of law and regulation, including, but not limited to, storage, security, and recordkeeping. E. Within 14 days of a change in the responsible party or supervising practitioner assigned to the registration, either the responsible party or outgoing responsible party shall inform the board and a new application shall be submitted indicating the name and license number, if applicable, of the new responsible party or supervising practitioner. 18VAC110-20-725.  Repackaging by a CSB or BHA. A. Definition. For purposes of this section, "repackaging" shall mean removing a drug from a container already dispensed and labeled by a pharmacy or medical practitioner authorized to dispense, for a particular client of a CSB or BHA, and placing it in a container that is designed for a person to be able to repackage his own dispensed prescription medications to assist with self-administration and compliance with dosage instructions. Such repackaging shall not include the preparation of a patient-specific label which includes drug name, strength, or directions for use or any other process restricted to a pharmacist or pharmacy technician under the direct supervision of a pharmacist. B. Persons authorized to repackage. Repackaging shall be performed by a pharmacist, pharmacy technician, nurse, or such other person who has successfully completed a board-approved training program for repackaging of prescription drug orders as authorized in § 54.1-3420.2.  A CSB or BHA using such other persons shall maintain documentation of completion of an approved training program for at least one year from date of termination of employment or cessation of repackaging activities.    C. Requirements for repackaging. 1. The repackaging of a dispensed prescription drug order pursuant to § 54.1-3420.2 shall only be done at a CSB or BHA. 2. The repackaging of dispensed prescription drugs shall be restricted to solid oral dosage forms and a maximum of a 14-day supply of drugs. 3. The drug container used for repackaging pursuant to this section shall bear a label containing the client’s first and last name, and name and 24-hour contact information for the CSB or BHA. 4. A clean, well-closed container that assists the client with self-administration shall be used when multiple doses of a repackaged drug are provided to the client at one time.  5. A prescription drug order shall not be repackaged beyond the assigned expiration date noted on the prescription label of the dispensed drug, if applicable, or beyond one year from the date the drug was originally dispensed by a pharmacy, whichever date is earlier.   D. Written information for client.   At the time a repackaged drug is initially given to a client, and upon any subsequent change in the medication order, the client shall be provided written information about the name and strength of the drug and the directions for use.  Such written information shall have been prepared by a pharmacy or by a nurse at the CSB or BHA.  E. Retention, storage and destruction of repackaged drugs. 1. Any portion of a client’s prescription drug order not placed into a container intended to assist with self-administration may be either given to the client or retained by the CSB or BHA for subsequent repackaging. If retained by the CSB or BHA, the remaining portion shall be stored within the board-approved drug storage location in the original labeled container, and shall only be used for the client for whom the drug was originally dispensed. 2. Any portion of a prescription drug order remaining at the CSB or BHA that has exceeded any labeled expiration date or one year from the original pharmacy dispensing date on the label shall be separated from unexpired drugs, stored within a designated area of the board-approved drug storage location, and destroyed within 30 days of expiration with the written agreement of the client.  Remaining portions of discontinued prescription drug orders retained by the CSB or BHA shall also be separated from active stock and either returned to the client or destroyed within 30 days of discontinuance with the written agreement of the client. F. Recordkeeping. 1. A record of repackaging shall be made and maintained for one year from the date of repackaging and shall include the following: a. Date of repackaging; b. Name of client; c. Prescription number of the originally dispensed prescription drug order; d. Pharmacy name; e. Drug name and strength; f. Quantity of drug repackaged; and g. Initials of the person performing the repackaging and verifying the accuracy of the repackaged drug container. 2. A record of destruction shall be made and maintained for one year for any prescription drug orders destroyed by the CSB or BHA and shall include the following: a. Date of destruction: b. Name of client; c. Prescription number of the originally dispensed prescription drug order; d. Drug name and strength; e. Quantity of drug destroyed; and f. Initials of the person performing the destruction.  18VAC110-20-726. Criteria for approval of repackaging training programs. A. Application. Any person wishing to apply for approval of a repackaging training program shall submit the application fee prescribed in 18VAC110-20-20 and an application on a form approved by the board and shall meet the criteria established in this section.  The application shall name a program director who is responsible for compliance with this section. B. Curriculum. The curriculum for a repackaging training program shall include instruction in current laws and regulations applicable to a CSB or BHA for the purpose of assisting a client with self-administration pursuant to §54.1-3420.2, and in the following repackaging tasks: a. Selection of an appropriate container; b. Proper preparation of a container in accordance with instructions for administration; c. Selection of the drug; d. Counting of the drug; e. Repackaging of the drug within the selected container; f. Maintenance of records; g. Proper storage of drugs; h. Translation of medical abbreviations; i. Review of administration records and prescriber's orders for the purpose of identifying any changes in dosage administration; j. Reporting and recording the client's failure to take medication; k. Identification, separation and removal of expired or discontinued drugs; and l. Prevention and reporting of repackaging errors.    C.  Instructors and program director. Instructors for the program shall be either (i) a pharmacist with a current license in any jurisdiction and who is not currently suspended or revoked in any jurisdiction in the United States; or (ii) a pharmacy technician with at least one year of experience performing technician tasks who holds a current registration in Virginia or current PTCB certification and who is not currently suspended or revoked in any jurisdiction in the United States. The program director shall maintain a list of instructors for the program. D. Program requirements. 1. The length of the program shall be sufficient to prepare a program participant to competently perform repackaging consistent with §54.1-3420.2 and 18 VAC 110-20-725. 2. The program shall include a post-training assessment to demonstratethe knowledge and skills necessary for repackaging with safety and accuracy.    3. A program shall provide a certificate of completion to participants who successfully complete the program and provide verification of completion of the program for a participant upon request by a CSB or BHA or by the board. 4. The program shall maintain records of training completion by persons authorized to repackage in accordance with §54.1-3420.2.  Records shall be retained for two years from date of completion of training or termination of the program. 5. The program shall report within 14 days any substantive change in the program to include a change in program name, program director, name of institution or business if applicable, address, program content, length of program, or location of records. E.  Expiration and renewal of program approval. A repackaging training program approval expires after two years, after which the program may apply for renewal.  For continued approval, the program shall submit the renewal application, renewal fee, and a self-evaluation report on a form provided by the board at the time of renewal notification. Renewal of a program's approval is at the discretion of the board, and the decision to renew shall be based on documentation of continued compliance with the criteria set forth in this section.  18VAC110-20-727.  Pharmacists repackaging for clients of a CSB or BHA   As an alternative to repackaging as defined in 18 VAC 110-20-725, a pharmacist at a CSB or BHA may repackage a client's prescription drugs that have been dispensed by another pharmacy into compliance packaging that complies with the requirements of 18 VAC 110-20-340 B and 18 VAC 110-20-725, subsections G, H, and J.  A primary provider pharmacy may also provide this service in compliance with the provisions of 18 VAC 110-20-535.   18VAC110-20-728.  Drugs for immediate treatment in crisis stabilization units.   A. In accordance with § 54.1-3423, a crisis stabilization unit shall apply and obtain a controlled substances registration in order to maintain a stock of Schedule VI controlled substances for immediate treatment of patients in crisis.  Schedule II-V controlled substances shall not be stocked.  The responsible party listed on the application shall be a nurse who regularly administers controlled substances at the crisis stabilization unit and the supervising practitioner shall be either the medical director for the unit or a pharmacist from a provider pharmacy.    B. In consultation with a provider pharmacist, the medical director for the unit shall determine the list of controlled substances to be stocked at the crisis stabilization unit.  The list shall be limited to Schedule VI controlled substances and only those drugs routinely used for treatment of patients admitted for crisis stabilization.  Only drugs on this drug list may be stocked.    C. A nurse administering a drug from this stock pursuant to an oral order of a prescriber in accordance with § 54.1-3423, shall record such order in the patient's medical record.     D.  Records.   1. A record shall be maintained of all drugs received as stock by the crisis stabilization unit.   2. A record shall be made documenting administration or other authorized disposition of stocked drugs that includes the following:   a. Name of patient;   b. Date and time of administration;   c. Drug name, strength, and quantity administered;   d. Name or initials of person administering; and   e. Prescriber name.     3. Records shall be maintained at the same location listed on the controlled substances registration or, if maintained in an off-site database, retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.  Any computerized system used to maintain records shall also provide retrieval via computer monitor display or printout of the history for drugs administered during the past two years.  It shall also have the capacity of producing a printout of any data which the registrant is responsible for maintaining.   4. Manual records may be maintained as an electronic image that provides an exact image of the document and is clearly legible.                 

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