Controlled Substance Administration

CONTROLLED SUBSTANCES FAQ
For California Licensed Veterinarians

  1. Who is required to keep records and file reports?
    1. Any “registrant” is required to keep records and inventories. The type of records required depends on the “activity” category. (e.g. – manufacturer, dispenser, researcher) [21 CFR §1304.03]
  2. What activities must be recorded?
    1. A “registered individual practitioner” is required to keep records of controlled substances which are dispensed [21 CFR §1304.03(b)] or administered [21 CFR §1304.03(d)].
    2. Federal regulations do NOT require records of controlled substances that are prescribed, however State regulations require a record of all prescribed medications, including dose, frequency and quantity in the patient medical record. (e.g. – written/electronic prescription filled by a pharmacy) [21 CFR §1304.03(c) ; 16 CCR §2032.3; 16 CCR §2032.2]
  3. How must records be kept?
    1. Each registered individual practitioner must keep the following two separate and distinct records: [21 CFR §1304.04(g)]
      1. One set of all Schedule I and II controlled substances, [21 CFR §1304.04(f)(1)] and
      2. One set of all Schedule III, IV, and V controlled substances. [21 CRF §1304.04(f)(2)]
    2. Records must be kept for at least 2 years from the date of each inventory or record [21 CFR §1304.04(a)] OR 3 years from the date of the animal’s last visit [21 CCR §2032.3(b)], whichever is greater, and must be available for inspection and copying by authorized Drug Enforcement Administration or Board personnel.
  4. What record keeping is required for inventory records?
    1. Each registered location must contain a complete and accurate record of all controlled substances on hand at the registered location and indicate whether the inventory was as of “close of business” or “opening of business.” [21 CFR §1304.11(a)]
      1. An initial inventory must be taken on the date the registrant first commences practice at the registered location. [21 CFR §1304.11(b)]
      2. After the initial inventory, a new and complete inventory must be taken every two years (biennially). [21 CFR §1304.11(c)]
      3. Shipping/ purchase records must be kept showing the number of units of finished forms and/or commercial containers acquired from other persons, including the name, address and registration number of the person (e.g. – sales receipts from drug vendors) [21 CFR §1304.22(a)(2(iv)];
    2. Veterinarians treating patients must maintain records specified in 21 CFR §1304.11(e)(3).
      1. Veterinarians are “dispensers” for the purposes of complying with Federal Controlled Substances requirements. [B&P §4024]
      2. The inventory shall include: [21 CFR §1304.11(e)(1)(iii)]
        1. The name of the substances,
        2. Each finished form (e.g. – 10 mg tab or 10 mg/ml)
        3. The number of units or volume of each finished form e.g. – 100 tablet bottles or 3 ml vials)
        4. The number of commercial containers of each finished form (e.g. – pack of 4 100-tablet bottles, or pack of six 3-ml vials)
      3. For any other controlled substances not included above (e.g. – expired drugs): [21 CFR §1304.11(e)(iv)]
        1. The name of the substance,
        2. The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and
        3. The reason the substance is being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substances in finished form.
  5. What records are required for dispensing and administration of controlled substances?
    1. Every registrant is required to keep records of each controlled substance that is dispensed, administered or disposed of, in any manner. [21 CFR §1304.21(a)]
    2. Practicing veterinarians are classified as dispensers. [21 CFR §1304.22(c)] and must keep records (i.e. – the Controlled Drug Log) for each controlled substance in finished form that include:
      1. The name of each substance [21 CFR §1304.22(a)(2)(i);
      2. Each finished form and the number of units or volume of finished form [21 CFR §1304.22(a)(2)(ii)];
      3. The number of units of finished forms and/or commercial containers acquired from other persons, including the name, address and registration number of the person (e.g. – sales receipts from drug vendors) [21 CFR §1304.22(a)(2(iv)];
      4. The number of commercial containers distributed to other persons, including the name, address and registration number of the person [21 CFR §1304.22(a)(2)(vii)];
      5. The number of units of finished forms and/or commercial containers distributed or disposed of (e.g. – expired drugs) in any other manner [21 CFR §1304.22(a)(2)(ix)];
      6. The number of units or volume of such finished form dispensed, including: [21 CFR §1304.22(c)]
        1. The number of units or volume of such finished form dispensed;
        2. The name and address of the person to whom it was dispensed;
        3. The date of dispensing;
        4. The number of units or volume dispensed;
        5. The name or initials of the person dispensing or administering the substance on behalf of the registrant.
    3. The medical record must include the dosage, quantity and frequency of all drugs dispensed or administered. [16 CCR §2032.3(a)(8,12)]
  6. Reporting requirements.
    1. All Schedule II, III, and IV substances which are dispensed must be reported weekly to the Controlled Substance Utilization Review and Evaluation System (“CURES”). [B&P §4170; Health & Safety Code §11190]
    2. The CURES log must contain:
      1. The prescriber’s name, address, telephone number, State license number and DEA number;
      2. Date of dispensing;
      3. Numeric quantity of controlled substance dispensed;
      4. Drug name;
      5. National Drug Code (NDC) number;
      6. Strength of the prescription (e.g. – 10 mg tab, 10 mg/ml);
      7. Client’s full name;
      8. Client’s date of birth
      9. Client’s gender code;
      10. Client’s address;
      11. Animal patient’s name;
      12. Reporting Month/Year;
      13. Date submitted.
    3. Theft & Loss
      1. A registrant must report the “significant” theft or loss of any controlled substance within one business day of discovery of the theft or loss to the local Field Office of the DEA. [21 CFR §1301.76(b)]

The Bureau of Narcotics Enforcement (BNE) has created a reporting tool for use by veterinarians specifically. More information is located on the BNE website at ag.ca.gov/bne/cures.php. Additional information about CURES may also be obtained from that website.

The terms used in this bulletin are defined either by federal law or California law or both. Definitions can be found at 21 USC 801, 21 CFR 1300, Health and Safety Code sections 11000 – 11033, and throughout the Veterinary Medical Practice Act and the Pharmacy Law found in the Business and Professions Code.

Veterinarians are specifically covered under the definitions pertaining to dispensing and administering in both federal and state law. Veterinarians may be covered under other definitions, such as researcher, depending upon the nature of their work. All DEA registration holders are subject to record keeping and reporting requirements and the Board has specific authority to enforce state pharmacy laws through B&P section 4170(b). State pharmacy law incorporates federal law enforcement through numerous sections (e.g. section 4052 requiring registration with DEA and 4066 requiring conformity with 21 CFR 1301.28) which the Board is also authorized to enforce through section 4170(b).

Resources:
California Veterinary Medical Board website www.vmb.ca.gov
California Pharmacy Board website www.pharmacy.ca.gov
CURES ag.ca.gov/bne/cures.phpp
NDC drug number www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM070829

Federal Law: www.deadiversion.usdoj.gov
Controlled Substances Act, 21 USC 801 – 904
Code of Federal Regulations. 21 CFR Part 1300 – 1399

California Law: www.leginfo.ca.gov or www.oal.ca.gov
Veterinary Practice Act, Business & Professions Code section 4800 - 4917
Veterinary Medical Board Regulations, Title 16 Code of Regulations sections 2000 - 2085.13
Pharmacy Laws, Business & Professions Code section 4000 through 4426.
Pharmacy Board Regulations, Title 16 Code of Regulations sections 1700-1795
Controlled Substances Act, Health and Safety Code section 11000-11717