Part IV. Written Prescription and Record Keeping Standards
18VAC110-30-170. Sign and written prescription requirements.
A. The licensee shall conspicuously display a sign in the public area of the office and in each patient examination room advising patients of their right to choose where they have their prescriptions filled.
B. The licensee shall advise patients of their right to obtain the controlled substance from him or from a pharmacy.
C. If the patient chooses to obtain the controlled substance from a pharmacy, the licensee shall either provide the patient with a written prescription or transmit the prescription orally, electronically or by fax to a pharmacy of his choice.
D. If the patient chooses to purchase the controlled substance from the licensee, the licensee shall either:
1. Have the patient sign the written prescription and return it to the licensee. If the licensee chooses to use the hard copy prescription as his record of sale, he shall record all information and file as required by 18VAC110-30-190. If the licensee chooses to record the sale in book form or maintain it in an automated data system, he shall mark the prescription void, file chronologically, and maintain for a period of two years; or
2. In lieu of a written prescription, have the patient sign a separate waiver form to be maintained for at least two years with the dispensing records according to date of dispensing. The waiver form may not be kept in the patient's chart.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 4.1, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006.
18VAC110-30-180. Manner of maintaining inventory records for licensees selling controlled substances.
Each licensee shall maintain the inventories and records of controlled substances as follows:
1. Inventories and records of all controlled substances listed in Schedule II shall be maintained separately from all other records of the licensee;
2. Inventories and records of controlled substances listed in Schedules III, IV and V may be maintained separately or with records of Schedule VI controlled substances but shall not be maintained with other records of the licensee;
3. All records of Schedule II through V controlled substances shall be maintained at the same location as the stock of controlled substances to which the records pertain except that records maintained in an off-site database shall be retrieved and made available for inspection within 48 hours of a request by the board or an authorized agent;
4. In the event that an inventory is taken as the result of a theft of controlled substances pursuant to § 54.1-3404 of the Drug Control Act of the Code of Virginia, the inventory shall be used as the opening inventory within the current biennial period. Such an inventory does not preclude the taking of the required inventory on the required biennial inventory date;
5. 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; and
6. All records required by this section shall be filed chronologically.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 4.2, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 22, Issue 10, eff. February 22, 2006.
18VAC110-30-190. Manner of maintaining records for Schedule II through VI controlled substances sold.
A. A hard copy prescription shall be placed on file for every new prescription dispensed and be maintained for two years from date of last refill. All prescriptions shall be filed chronologically from date of initial dispensing. In lieu of a hard copy prescription, a licensee may have an alternative record of all drugs sold maintained for two years from date of dispensing or of refilling an order. Such record shall be in chronological order by date of initial dispensing with refills listed with initial dispensing information or by date of dispensing.
B. The hard copy prescription or records of sale for Schedule II controlled substances shall be maintained as follows:
1. They shall be maintained separately from other records; and
2. They shall be maintained in chronological order and shall show the selling date, a number which identifies the sale, the name and address of the patient, the name and strength of the controlled substance, the initials of the licensee, and the quantity sold.
C. The hard copy prescription or records of sale for Schedule III through V controlled substances shall be maintained as follows:
1. They shall be maintained in the manner set forth in subsection A of this section; and
2. The hard copy prescription or records of sale for Schedule III through V controlled substances may be maintained separately from other selling records or may be maintained with selling records for Schedule VI controlled substances provided the Schedule III through V controlled substance records are readily retrievable from the selling records for Schedule VI controlled substances. The records shall be deemed readily retrievable if a red "C" is placed uniformly on the record entry line for each Schedule III through V controlled substance sold. However, if the licensee 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 record with a red "C" is waived.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 4.3, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006.
18VAC110-30-200. Automated data processing records of sale.
A. An automated data processing system may be used for the storage and retrieval of the sale of controlled substances instead of manual recordkeeping requirements, subject to the following conditions:
1. Any computerized system shall also provide retrieval via computer monitor display or printout of the sale of all controlled substances during the past two years, the listing to be in chronological order and shall include all information required by the manual method; and
2. If the system provides a printout of each day's selling activity, the printout shall be verified, dated and signed by the licensee. The licensee shall verify that the data indicated is correct and then sign the document in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). In place of such printout, the licensee shall maintain a bound log book, or separate file, in which the licensee shall sign a statement each day, in the manner previously described, attesting to the fact that the selling information entered into the computer that day under his initials has been reviewed by him and is correct as shown.
B. Any computerized system shall have the capability of producing a printout of any selling data which the practitioner is responsible for maintaining under the Drug Control Act and 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 VR530-01-2 § 4.4, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006.