PURPOSE: This rule establishes procedures for disposing of unwanted controlled substances.

1. (1) A registrant in possession of any controlled substance(s) and desiring or required to dispose of such substance(s) shall:

   1. (A) Return the controlled substances to the original supplier;
   2. (B) Transfer the controlled substances to a distributor authorized to accept controlled substances for the purpose of disposal;
   3. (C) Submit a DEA Form 41 to the federal Drug Enforcement Administration requesting authorization to dispose of the controlled substances in compliance with federal regulations;
   4. (D) Contact the Bureau of Narcotics and Dangerous Drugs (BNDD), Department of Health for information pertaining to subsections (1)(A), (B) or (C).
2. (2) The return, transfer or disposal of any controlled substance shall be documented in accordance with 19 CSR 30-1.044.

3. (3) In the event the registrant is a hospital, the following procedures are to be used for the destruction of controlled substances:

   1. (A) When disposal of controlled substances is in patient care areas—

      1. 1. Controlled substances which are con-

taminated by patient body fluids are to be destroyed by a physician, nurse or a pharmacist in the presence of another hospital employee;

1. 2. An excess volume of a controlled sub-

stance which must be discarded from a dosage unit just prior to use shall be destroyed by a nurse, pharmacist or physician in the presence of another hospital employee;

1. 3. The remaining contents of opened 19 CSR 30-1

glass ampules of controlled substances shall be destroyed by a nurse, pharmacist or physician in the presence of another hospital employee;

1. 4. Single units of single dose packages

of controlled substances which are contaminated other than by patient body fluids and are not an infectious hazard, or have been removed from their original or security packaging, or are partially used, or are otherwise rendered unsuitable for patient use shall be destroyed by a nurse, pharmacist or physician in the presence of another hospital employee or returned to the pharmacy for destruction;

1. 5. The following shall be entered in the

controlled substance administration record or a separate controlled substance destruction record when the controlled substance is destroyed in the patient care area: the date and hour of destruction, the drug name and strength, the amount destroyed, the reason for destruction and the patient’s name and room number. The nurse, pharmacist or physician and the witnessing hospital employee shall sign the entry. The drug shall be destroyed so that it is beyond reclamation. The controlled substance administration or destruction records are to be retained for two years and available for inspection by Department of Health investigators;

1. 6. All other controlled substances which

are not patient contaminated but which are to be disposed of shall be returned to the pharmacy for disposal;

1. (B) When disposal of controlled substances is in the pharmacy—

   1. 1. Single units of controlled substances

which are contaminated other than by patient body fluids and are not an infectious hazard, or have been removed from their original or security packaging, or are partially used, or are otherwise rendered unsuitable for patient use shall be destroyed by a pharmacist in the presence of another hospital employee or held for later destruction;

1. 2. All other controlled substances which

are not patient contaminated but are to be disposed of shall be placed in a suitable container for storage and disposed of as described in section (1) of this rule.

1. (4) If the registrant administers controlled substances and is not a hospital, the following procedures are to be used for the destruction of controlled substances:

   1. (A) Controlled substances which are contaminated by patient body fluids are to be destroyed, in the presence of another employee, by the registrant or designee authorized to administer;
   2. (B) An excess volume of a controlled substance which must be discarded from a AND SENIOR SERVICES

dosage unit just prior to use is to be destroyed, in the presence of another employee, by the registrant or designee authorized to administer;

1. (C) The remaining contents of opened glass ampules of controlled substances which are not patient contaminated are to be destroyed, in the presence of another employee, by the registrant or designee authorized to administer;
2. (D) When the controlled substance is destroyed by the registrant or designee authorized to administer, the following shall be entered in the controlled substances administration records or a separate controlled substances destruction record: the date and amount destroyed, the reason for destruction and the registrant’s name and address. The registrant or designee doing the destruction and the witnessing employee shall sign the entry. The drug shall be destroyed so that it is beyond reclamation. The controlled substances administration or destruction records are to be retained for two years and available for inspection by Department of Health investigators;
3. (E) All other controlled substances which are not patient-contaminated but are to be disposed of shall be placed in a suitable container for storage and disposed of as described in section (1) of this rule.

AUTHORITY: sections 195.050 and 195.195, RSMo 1994.* Original rule filed April 14, 2000, effective Nov. 30, 2000. *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, 1993.