Part IV. Drug Inventory and Records
18VAC110-20-240. Manner of maintaining records, prescriptions, inventory records.
A. Each pharmacy shall perform and maintain the inventories and records of drugs as follows:
1. Inventories and records of all drugs listed in Schedules I and II shall be maintained separately from all other records of the pharmacy. Inventories of drugs in Schedules I and II shall be performed by physically counting the drugs. Each pharmacy shall maintain a perpetual inventory of all Schedule II drugs received and dispensed that accurately indicates the physical count of each Schedule II drug "on-hand" at the time of performing the inventory. The perpetual inventory shall include a reconciliation of each Schedule II drug at least monthly with a written explanation for any difference between the physical count and the theoretical count. Electronic monitoring at the pharmacy or by another entity that provides alerts for discrepancies between drugs received and drugs dispensed is acceptable provided such alerts are reviewed at least monthly.
2. Inventories and records of drugs listed in Schedules III, IV, and V may be maintained separately or with records of Schedule VI drugs but shall not be maintained with other records of the pharmacy. Inventories of drugs in Schedules III, IV, and V may be performed by estimating the count of drugs in Schedules III, IV, and V unless the container contains greater than 1,000 tablets or capsules or there has been a theft or any other unusual loss of drug and the exact kind and quantity of the drug loss is unknown.
3. All executed order forms, prescriptions, and inventories of Schedules II through V drugs shall be maintained at the same address as the stock of drugs to which the records pertain. If authorized by DEA, other records pertaining to Schedules II through V drugs, such as invoices, may be maintained in an off-site database or in secured storage. All records in off-site storage shall be retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.
4. All inventories required by § 54.1-3404 of the Code of Virginia shall be signed and dated by the person taking the inventory and shall indicate whether the inventory was taken prior to the opening of business or after close of business. A 24-hour pharmacy with no opening or closing of business shall clearly document whether the receipt or distribution of drugs on the inventory date occurred before or after the inventory was taken.
5. Invoices or other records showing receipts of Schedule VI drugs shall be maintained but may be stored in an electronic database or record as an electronic image that provides an exact, clearly legible image of the document or in secured storage either onsite or offsite. All records in off-site storage or database shall be retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.
6. All records required by this section shall be filed chronologically and maintained for a period of not less than two years from the date of transaction.
B. Prescriptions.
1. A hard copy prescription shall be placed on file for every initial prescription dispensed and be maintained for two years from the date of last refill. All prescriptions shall be filed chronologically by date of initial dispensing or by date of initial entry into the automated data processing system in compliance with 18VAC110-20-250 if such a system is employed by the pharmacy.
2. Schedule II drugs. Prescriptions for Schedule II drugs shall be maintained in a separate prescription file.
3. Schedules III, IV, and V drugs. Prescriptions for Schedules III, IV, and V drugs shall be maintained either in a separate prescription file for drugs listed in Schedules III, IV, and V only or in such form that they are readily retrievable from the other prescriptions of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than one inch high and filed in the prescription file for drugs listed in the usual consecutively numbered prescription file for Schedule VI drugs. However, if a pharmacy employs an automated data processing system or other electronic recordkeeping system for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived.
C. Chart orders.
1. A chart order written for a patient in a hospital or long-term care facility, a patient receiving home infusion services, or a hospice patient pursuant to § 54.1-3408.01 A of the Code of Virginia shall be exempt from having to contain all required information of a written prescription provided:
a. This information is contained in other readily retrievable records of the pharmacy; and
b. The pharmacy maintains and complies with a current policy and procedure manual that sets out where this information is maintained, how to retrieve it, and the minimum requirements for chart orders consistent with state and federal law and accepted standard of care.
2. A chart order may serve as the hard copy prescription for those patients listed in subdivision 1 of this subsection. When a chart order is intended for out-patient dispensing, it shall comply with requirements for a prescription in 18VAC110-20-286.
3. Requirements for filing of chart orders.
a. Chart orders shall be filed chronologically by date of initial dispensing with the following exception: If dispensing data can be produced showing a complete audit trail for any requested drug for a specified time period and each chart order is readily retrievable upon request, chart orders may be filed using another method. Such alternate method shall be clearly documented in a current policy and procedure manual.
b. If a single chart order contains both an order for a Schedule II drug and one or more orders for a drug in another schedule, where the Schedule II drug is not floor stocked but is dispensed from the pharmacy pursuant to this order for the specific patient, the original order must be filed with records of dispensing of Schedule II drugs and a copy of the order placed in the file for other schedules.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 5.1, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 12, Issue 21, eff. August 7, 1996; Volume 15, Issue 8, eff. February 3, 1999; Volume 19, Issue 20, eff. July 16, 2003; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 30, Issue 10, eff. February 12, 2014; Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-250. Automated data processing records of prescriptions.
A. An automated data processing system may be used for the storage and retrieval of original and refill dispensing information for prescriptions instead of manual recordkeeping requirements, subject to the following conditions:
1. A prescription shall be placed on file as set forth in 18VAC110-20-240 B with the following provisions:
a. In lieu of a hard copy file for Schedule VI prescriptions, an electronic image of a prescription may be maintained in an electronic database provided it preserves and provides an exact image of the prescription that is clearly legible and made available within 48 hours of a request by a person authorized by law to have access to prescription information. Storing electronic images of prescriptions for Schedules II through V controlled substances instead of the hard copy shall only be authorized if such storage is allowed by federal law.
b. If the pharmacy system's automated data processing system fields are automatically populated by an electronic prescription, the automated record shall constitute the prescription and a hard copy or electronic image is not required.
c. For Schedules II through V controlled substances, electronic prescriptions shall be maintained in accordance with federal law and regulation.
2. Any computerized system shall provide retrieval (via computer monitor display or printout) of original prescription information for those prescriptions which are currently authorized for dispensing.
3. Any computerized system shall also provide retrieval via computer monitor display or printout of the dispensing history for prescriptions dispensed during the past two years.
4. Documentation indicating that the information entered into the computer system is correct for each on-hold prescription or for each prescription that is dispensed shall be provided by the individual pharmacist who makes use of such system. If a printout is maintained of each day's prescription dispensing data or data entry of an on-hold prescription, the printout shall be verified, dated, and signed by the individual pharmacist who dispensed the prescription or verified the accuracy of the data entry. The individual pharmacist shall verify that the data indicated is correct and then sign the document in the same manner as his name appears on his pharmacist license (e.g., J. H. Smith or John H. Smith).
If a bound log book or separate file is maintained rather than a printout, each individual pharmacist involved in dispensing shall sign a statement each day in the log, in the manner previously described, attesting to the fact that the dispensing information and data entry of on-hold prescriptions entered into the computer that day have been reviewed by him and are correct as shown.
B. Printout of dispensing data requirements. Any computerized system shall have the capability of producing a printout of any dispensing data which the user pharmacy is responsible for maintaining under the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia) and any data entry of on-hold prescriptions. Such printout shall be provided within 48 hours of a request of an authorized agent.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 5.2, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 20, Issue 23, eff. August 25, 2004; Volume 26, Issue 22, eff. August 4, 2010; Volume 30, Issue 10, eff. February 12, 2014.
18VAC110-20-255. Other dispensing records.
Pursuant to § 54.1-3412 of the Code of Virginia, any other record used to record the date of dispensing or the identity of the pharmacist dispensing shall be maintained for a period of two years on premises. A pharmacy using such an alternative record shall maintain a current policy and procedure manual documenting the procedures for using the record, how the record is integrated into the total dispensing record system, and how the data included in the record shall be interpreted.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 19, Issue 20, eff. July 16, 2003.
18VAC110-20-260. (Repealed.)
Historical Notes
Derived from VR530-01-1 § 5.2, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 12, Issue 21, eff. August 7, 1996; repealed, Virginia Register Volume 15, Issue 8, eff. February 3, 1999.