Title of Regulation: 18VAC150-20. Regulations Governing the Practice of Veterinary Medicine (amending 18VAC150-20-190).

Statutory Authority: §§ 54.1-2400 and 54.1-3804 of the Code of Virginia.

Effective Date: September 18, 2019.

Agency Contact: Leslie L. Knachel, Executive Director, Board of Veterinary Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 597-4130, FAX (804) 527-4471, or email leslie.knachel@dhp.virginia.gov.

Summary:

The amendment adds requirements mandated by Chapter 686 of the 2019 Acts of Assembly that every veterinary establishment licensed by the Board of Veterinary Medicine (i) maintain records of the dispensing of feline buprenorphine and canine butorphanol, (ii) reconcile such records monthly, and (iii) make such records available for inspection upon request.

18VAC150-20-190. Requirements for drug storage, dispensing, destruction, and records for all establishments.

A. All drugs shall be maintained, administered, dispensed, prescribed, and destroyed in compliance with state and federal laws, which include § 54.1-3303 of the Code of Virginia, the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), applicable parts of the federal Food, Drug, and Cosmetic Control Act (21 USC § 301 et seq.), the Prescription Drug Marketing Act (21 USC § 301 et seq.), and the Controlled Substances Act (21 USC § 801 et seq.), as well as applicable portions of Title 21 of the Code of Federal Regulations.

B. All repackaged tablets and capsules dispensed for companion animals shall be in approved safety closure containers, except safety caps shall not be required when any person who requests that the medication not have a safety cap, or in such cases in which the medication is of such form or size that it cannot be reasonably dispensed in such containers (e.g., topical medications, ophthalmic, or otic). An owner request for nonsafety packaging shall be documented in the patient record.

C. All drugs dispensed for companion animals shall be labeled with the following:

1. Name and address of the facility;

2. First and last name of owner;

3. Animal identification and species;

4. Date dispensed;

5. Directions for use;

6. Name, strength (if more than one dosage form exists), and quantity of the drug; and

7. Name of the prescribing veterinarian.

D. All veterinary establishments shall maintain drugs in a secure manner with precaution taken to prevent theft or diversion. Only the veterinarian, veterinary technician, pharmacist, or pharmacy technician shall have access to Schedules II through V drugs, with the exception provided in subdivision 6 of this subsection.

1. In a stationary establishment, the general stock of Schedules II through V drugs shall be stored in a securely locked cabinet or safe that is not easily movable.

2. The establishment may also have a working stock of Schedules II through V drugs that shall be kept in (i) a securely locked container, cabinet, or safe when not in use or (ii) direct possession of a veterinarian or veterinary technician. A working stock shall consist of only those drugs that are necessary for use during a normal business day or 24 hours, whichever is less.

3. Whenever the establishment is closed, all general and working stock of Schedules II through V drugs and any dispensed prescriptions that were not delivered during normal business hours shall be securely stored as required for the general stock.

4. Prescriptions that have been dispensed and prepared for delivery shall be maintained under lock or in an area that is not readily accessible to the public and may be delivered to an owner by an unlicensed person, as designated by the veterinarian.

5. Whenever a theft or any unusual loss of Schedules II through V drugs is discovered, the veterinarian-in-charge, or in his absence, his designee, shall immediately report such theft or loss to the Board of Veterinary Medicine and the Board of Pharmacy and to the DEA. The report to the boards shall be in writing and sent electronically or by regular mail. The report to the DEA shall be in accordance with 21 CFR 1301.76(b). If the veterinarian-in-charge is unable to determine the exact kind and quantity of the drug loss, he shall immediately take a complete inventory of all Schedules II through V drugs.

6. Access to drugs by unlicensed persons shall be allowed only under the following conditions:

a. An animal is being kept at the establishment outside of the normal hours of operation, and a licensed practitioner is not present in the facility;

b. The drugs are limited to those dispensed to a specific patient; and

c. The drugs are maintained separately from the establishment's general drug stock and kept in such a manner so they are not readily available to the public.

E. Schedules II through V drugs shall be destroyed by (i) transferring the drugs to another entity authorized to possess or provide for proper disposal of such drugs or (ii) destroying the drugs in compliance with applicable local, state, and federal laws and regulations. If Schedules II through V drugs are to be destroyed, a DEA drug destruction form shall be fully completed and used as the record of all drugs to be destroyed. A copy of the destruction form shall be retained at the veterinarian practice site with other inventory records.

F. The drug storage area shall have appropriate provision for temperature control for all drugs and biologics. If drugs requiring refrigeration are maintained at the facility, they the drugs shall be kept in a refrigerator with the interior thermometer maintained between 36°F and 46°F. If a refrigerated drug is in Schedules II through V, the drug shall be kept in a locked container secured to the refrigerator, or the refrigerator shall be locked. Drugs stored at room temperature shall be maintained between 59°F and 86°F.

G. The stock of drugs shall be reviewed frequently, and expired drugs shall be removed from the working stock of drugs at the expiration date and shall not be administered or dispensed.

H. A distribution record shall be maintained in addition to the patient's record, in chronological order, for the administration and dispensing of all Schedules II through V drugs.

This record is to be maintained for a period of three years from the date of transaction. This distribution record shall include the following:

1. Date of transaction;

2. Drug name, strength, and the amount dispensed, administered, and wasted;

3. Owner and animal identification; and

4. Identification of the veterinarian authorizing the administration or dispensing of the drug.

I. Original invoices for all Schedules II through V drugs received shall be maintained in chronological order on the premises where the stock of drugs is held, and the actual date of receipt shall be noted. All drug records shall be maintained for a period of three years from the date of transaction.

J. A complete and accurate inventory of all Schedules II through V drugs shall be taken, dated, and signed on any date that is within two years of the previous biennial inventory. Drug strength must be specified. This inventory shall indicate if it was made at the opening or closing of business and shall be maintained on the premises where the drugs are held for three years from the date of taking the inventory.

K. Inventories and records, including original invoices, of Schedule II drugs shall be maintained separately from all other records, and the establishment shall maintain a continuous inventory of all Schedule II drugs received, administered, or dispensed, with reconciliation at least monthly. Reconciliation requires an explanation noted on the inventory for any difference between the actual physical count and the theoretical count indicated by the distribution record. A continuous inventory shall accurately indicate the physical count of each Schedule II drug in the general and working stocks at the time of performing the inventory.

L. Veterinary establishments shall (i) maintain records of the dispensing of feline buprenorphine and canine butorphanol, (ii) reconcile such records monthly, and (iii) make such records available for inspection upon request.

L. M. Veterinary establishments in which bulk reconstitution of injectable, bulk compounding, or the prepackaging of drugs is performed shall maintain adequate control records for a period of one year or until the expiration, whichever is greater. The records shall show the name of the drugs used; strength, if any; date repackaged; quantity prepared; initials of the veterinarian verifying the process; the assigned lot or control number; the manufacturer's or distributor's name and lot or control number; and an expiration date.

M. N. If a limited stationary or ambulatory practice uses the facilities of another veterinary establishment, the drug distribution log shall clearly reveal whose Schedules II through V drugs were used. If the establishment's drug stock is used, the distribution record shall show that the procedure was performed by a visiting veterinarian who has the patient record. If the visiting veterinarian uses his own stock of drugs, he shall make entries in his own distribution record and in the patient record and shall leave a copy of the patient record at the other establishment.