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

1. (1) The following definitions shall be used in administering this rule:

   1. (A) Controlled substances administration record—the form used to record information when administering individual drug doses to patients;
   2. (B) Hospital—as defined in section 195.010(17), RSMo;
   3. (C) Hospital employee—a nurse, physician, pharmacist or other responsible patientcare employee;
   4. (D) Inventory record—the pharmacy record that documents the current inventory 19 CSR 30-1

level of controlled substances in the pharmacy;

1. (E) Nurse—registered or licensed practical nurse licensed under Chapter 335, RSMo; and
2. (F) Patient care areas—any area of a hospital where medical attention is rendered to a patient.

1. (2) A registrant in possession of any controlled substances and desiring or required to destroy the controlled substances beyond reclamation shall notify the Bureau of Narcotics and Dangerous Drugs (BNDD), the Drug Enforcement Administration (DEA) or other persons authorized by state or federal law or regulation to destroy controlled substances. If notification is to DEA, the federal procedures are to be followed. If notification is to the BNDD, the following procedures shall be used:

   1. (A) Notification by the registrant shall consist of the name and address of registrant; registrant’s BNDD and DEA number; the drug name, strength and amount to be destroyed; and
   2. (B) The BNDD shall instruct the registrant to dispose of the controlled substance in one

2. (1) of the following ways:

   1. 1. By delivery in person or registered

mail to the BNDD office closest to the registrant;

1. 2. By destruction at the registrant’s

work address by a BNDD employee or designee; or

1. 3. By other means as the BNDD shall

determine is sufficient to ensure that the substance will not become available to unauthorized personnel.

1. (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

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 (2) years and available for inspection by Department of Health investigators; and

1. 6. All other controlled substances which

are not patient contaminated but which are to be destroyed shall be returned to the pharmacy for destruction; and

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; and

1. 2. In the presence of the director or

assistant director of security, or the director or assistant director of nursing, or the hospital administrator or assistant administrator, the director of pharmacy or designated pharmacist may destroy beyond reclamation any other unwanted controlled substances provided—the BNDD of the Department of Health is notified in writing by certified mail fifteen (15) calendar days prior to the proposed destruction date using the registrant’s inventory of drugs destroyed or surrendered (Form NDD 12) stating the drug name and strength, the amount to be destroyed and the proposed destruction date and method of destruction. If the BNDD does not object, destruction shall occur on the proposed date. The pharmacist shall destroy the previously identified drugs, complete Form NDD 12 with the signature of the witness included and return a copy to the BNDD. The original shall be maintained at the hospital for two (2) years with other controlled substances records.

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 dosage unit just prior to use is to be destroyed, in the presence of another employee, by the registrant or designee authorized to administer;
   3. (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;
   4. (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 (2) years and available for inspection by Department of Health investigators; and
   5. (E) All other controlled substances which are not patient-contaminated but are to be destroyed shall be placed in a suitable container for storage, and the BNDD notified of the need for destruction.

AUTHORITY: section 195.050.6, RSMo 1986.* Original rule filed Jan. 18, 1989, effective April 27, 1989. *Original authority 1939, amended 1971, 1989.