(a) Drugs dispensed to patients in health care facilities
or institutions.
(1) Destruction by the consultant pharmacist. The consultant
pharmacist, if in good standing with the Texas State Board of Pharmacy,
is authorized to destroy dangerous drugs dispensed to patients in
health care facilities or institutions. A consultant pharmacist may
destroy controlled substances as allowed to do so by federal laws
or rules of the Drug Enforcement Administration. Dangerous drugs may
be destroyed provided the following conditions are met.
(A) A written agreement exists between the facility
and the consultant pharmacist.
(B) The drugs are inventoried and such inventory is
verified by the consultant pharmacist. The following information shall
be included on this inventory:
(i) name and address of the facility or institution;
(ii) name and pharmacist license number of the consultant
pharmacist;
(iii) date of drug destruction;
(iv) date the prescription was dispensed;
(v) unique identification number assigned to the prescription
by the pharmacy;
(vi) name of dispensing pharmacy;
(vii) name, strength, and quantity of drug;
(viii) signature of consultant pharmacist destroying
drugs;
(ix) signature of the witness(es); and
(x) method of destruction.
(C) The signature of the consultant pharmacist and
witness(es) to the destruction and the method of destruction specified
in subparagraph (B) of this paragraph may be on a cover sheet attached
to the inventory and not on each individual inventory sheet, provided
the cover sheet contains a statement indicating the number of inventory
pages that are attached and each of the attached pages are initialed
by the consultant pharmacist and witness(es).
(D) The drugs are destroyed in a manner to render the
drugs unfit for human consumption and disposed of in compliance with
all applicable state and federal requirements.
(E) The actual destruction of the drugs is witnessed
by one of the following:
(i) a commissioned peace officer;
(ii) an agent of the Texas State Board of Pharmacy;
(iii) an agent of the Texas Health and Human Services
Commission, authorized by the Texas State Board of Pharmacy to destroy
drugs;
(iv) an agent of the Texas Department of State Health
Services, authorized by the Texas State Board of Pharmacy to destroy
drugs; or
(v) any two individuals working in the following capacities
at the facility:
(I) facility administrator;
(II) director of nursing;
(III) acting director of nursing; or
(IV) licensed nurse.
(F) If the actual destruction of the drugs is conducted
at a location other than the facility or institution, the consultant
pharmacist and witness(es) shall retrieve the drugs from the facility
or institution, transport, and destroy the drugs at such other location.
(2) Destruction by a waste disposal service. A consultant
pharmacist may utilize a waste disposal service to destroy dangerous
drugs dispensed to patients in health care facilities or institutions.
A consultant pharmacist may destroy controlled substances as allowed
to do so by federal laws or rules of the Drug Enforcement Administration.
Dangerous drugs may be transferred to a waste disposal service for
destruction provided the following conditions are met.
(A) The waste disposal service is in compliance with
applicable rules of the Texas Commission on Environmental Quality
and United States Environmental Protection Agency relating to waste
disposal.
(B) The drugs are inventoried and such inventory is
verified by the consultant pharmacist prior to placing the drugs in
an appropriate container, and sealing the container. The following
information must be included on this inventory:
(i) name and address of the facility or institution;
(ii) name and pharmacist license number of the consultant
pharmacist;
(iii) date of packaging and sealing of the container;
(iv) date the prescription was dispensed;
(v) unique identification number assigned to the prescription
by the pharmacy;
(vi) name of dispensing pharmacy;
(vii) name, strength, and quantity of drug;
(viii) signature of consultant pharmacist packaging
and sealing the container; and
(ix) signature of the witness(es).
(C) The consultant pharmacist seals the container of
drugs in the presence of the facility administrator and the director
of nursing or one of the other witnesses listed in paragraph (1)(E)
of this subsection as follows:
(i) tamper resistant tape is placed on the container
in such a manner that any attempt to reopen the container will result
in the breaking of the tape; and
(ii) the signature of the consultant pharmacist is
placed over this tape seal.
(D) The sealed container is maintained in a secure
area at the facility or institution until transferred to the waste
disposal service by the consultant pharmacist, facility administrator,
director of nursing, or acting director of nursing.
(E) A record of the transfer to the waste disposal
service is maintained and attached to the inventory of drugs specified
in subparagraph (B) of this paragraph. Such record shall contain the
following information:
(i) date of the transfer;
(ii) signature of the person who transferred the drugs
to the waste disposal service;
(iii) name and address of the waste disposal service;
and
(iv) signature of the employee of the waste disposal
service who receives the container.
(F) The waste disposal service shall provide the facility
with proof of destruction of the sealed container. Such proof of destruction
shall contain the date, location, and method of destruction of the
container and shall be attached to the inventory of drugs specified
in subparagraph (B) of this paragraph.
(3) Record retention. All records required in this
subsection shall be maintained by the consultant pharmacist at the
health care facility or institution for two years from the date of
destruction.