22 Tex. Admin. Code § 303.1 - Destruction of Dispensed Drugs
(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, including any dangerous drugs comingled with the
controlled substances in a shared container, as allowed to do so by federal
laws or rules of the Drug Enforcement Administration. Dangerous drugs not
comingled with controlled substances 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 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.
(C) 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.
(D) A record of the transfer to the waste
disposal service is maintained. 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.
(E) 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.
(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.
(b) Drugs
returned to a pharmacy. A pharmacist in a pharmacy may accept and destroy
dangerous drugs that have been previously dispensed to a patient and returned
to a pharmacy by the patient or an agent of the patient. A pharmacist may
accept controlled substances that have been previously dispensed to a patient
as allowed by federal laws of the Drug Enforcement Administration. The
following procedures shall be followed in destroying dangerous drugs.
(1) The dangerous drugs shall be destroyed in
a manner to render the drugs unfit for human consumption and disposed of in
compliance with all applicable state and federal requirements.
(2) Documentation shall be maintained that
includes the following information:
(A) name
and address of the dispensing pharmacy;
(B) unique identification number assigned to
the prescription, if available;
(C)
name and strength of the dangerous drug; and
(D) signature of the pharmacist.
Notes
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No prior version found.