(i) Prescription drug orders for Schedules III-V controlled
substances may not be refilled more than five times or after six months
from the date of issuance of the original prescription drug order,
whichever occurs first.
(ii) If a prescription drug order for a Schedule III,
IV, or V controlled substance has been refilled a total of five times
or if six months have expired from the date of issuance of the original
prescription drug order, whichever occurs first, a new and separate
prescription drug order shall be obtained from the prescribing practitioner
prior to dispensing any additional quantities of controlled substances.
(D) Pharmacist unable to contact prescribing practitioner.
If a pharmacist is unable to contact the prescribing practitioner
after a reasonable effort, a pharmacist may exercise his or her professional
judgment in refilling a prescription drug order for a drug, other
than a Schedule II controlled substance, without the authorization
of the prescribing practitioner, provided:
(i) failure to refill the prescription might result
in an interruption of a therapeutic regimen or create patient suffering;
(ii) the quantity of prescription drug dispensed does
not exceed a 72-hour supply;
(iii) the pharmacist informs the patient or the patient's
agent at the time of dispensing that the refill is being provided
without such authorization and that authorization of the practitioner
is required for future refills;
(iv) the pharmacist informs the practitioner of the
emergency refill at the earliest reasonable time;
(v) the pharmacist maintains a record of the emergency
refill containing the information required to be maintained on a prescription
as specified in this subsection;
(vi) the pharmacist affixes a label to the dispensing
container as specified in §291.33(c)(7) of this title (relating
to Operational Standards); and
(vii) if the prescription was initially filled at another
pharmacy, the pharmacist may exercise his or her professional judgment
in refilling the prescription provided:
(I) the patient has the prescription container, label,
receipt or other documentation from the other pharmacy that contains
the essential information;
(II) after a reasonable effort, the pharmacist is unable
to contact the other pharmacy to transfer the remaining prescription
refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his or her professional judgment,
determines that such a request for an emergency refill is appropriate
and meets the requirements of clause (i) of this subparagraph; and
(IV) the pharmacist complies with the requirements
of clauses (ii) - (vi) of this subparagraph.
(E) Natural or man-made disasters. If a natural or
man-made disaster has occurred that prohibits the pharmacist from
being able to contact the practitioner, a pharmacist may exercise
his or her professional judgment in refilling a prescription drug
order for a drug, other than a Schedule II controlled substance, without
the authorization of the prescribing practitioner, provided:
(i) failure to refill the prescription might result
in an interruption of a therapeutic regimen or create patient suffering;
(ii) the quantity of prescription drug dispensed does
not exceed a 30-day supply;
(iii) the governor of Texas has declared a state of
disaster;
(iv) the board, through the executive director, has
notified pharmacies that pharmacists may dispense up to a 30-day supply
of prescription drugs;
(v) the pharmacist informs the patient or the patient's
agent at the time of dispensing that the refill is being provided
without such authorization and that authorization of the practitioner
is required for future refills;
(vi) the pharmacist informs the practitioner of the
emergency refill at the earliest reasonable time;
(vii) the pharmacist maintains a record of the emergency
refill containing the information required to be maintained on a prescription
as specified in this subsection;
(viii) the pharmacist affixes a label to the dispensing
container as specified in §291.33(c)(7) of this title; and
(ix) if the prescription was initially filled at another
pharmacy, the pharmacist may exercise his or her professional judgment
in refilling the prescription provided:
(I) the patient has the prescription container, label,
receipt or other documentation from the other pharmacy that contains
the essential information;
(II) after a reasonable effort, the pharmacist is unable
to contact the other pharmacy to transfer the remaining prescription
refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his or her professional judgment,
determines that such a request for an emergency refill is appropriate
and meets the requirements of clause (i) of this subparagraph; and
(IV) the pharmacist complies with the requirements
of clauses (ii) - (viii) of this subparagraph.
(F) Emergency Refills of Insulin and Insulin-Related
Equipment or Supplies.
(i) A pharmacist may exercise the pharmacist's professional
judgment in refilling a prescription for insulin or insulin-related
equipment or supplies without the authorization of the prescribing
practitioner if the pharmacist:
(I) is unable to contact the practitioner after reasonable
effort;
(II) is provided with documentation showing that the
patient was previously prescribed insulin or insulin-related equipment
or supplies by a practitioner;
(III) assesses the patient to determine whether the
emergency refill is appropriate;
(IV) creates a record that documents the patient's
visit that includes a notation describing the documentation provided
under subclause (II) of this clause; and
(V) makes a reasonable attempt to inform the practitioner
of the emergency refill at the earliest reasonable time.
(ii) The quantity of an emergency refill of insulin
may not exceed a 30-day supply. The quantity of an emergency refill
of insulin-related equipment or supplies may not exceed the lesser
of a 30-day supply or the smallest available package.
(G) Auto-Refill Programs. A pharmacy may use a program
that automatically refills prescriptions that have existing refills
available in order to improve patient compliance with and adherence
to prescribed medication therapy. The following is applicable in order
to enroll patients into an auto-refill program:
(i) Notice of the availability of an auto-refill program
shall be given to the patient or patient's agent, and the patient
or patient's agent must affirmatively indicate that they wish to enroll
in such a program and the pharmacy shall document such indication.
(ii) The patient or patient's agent shall have the
option to withdraw from such a program at any time.
(iii) Auto-refill programs may be used for refills
of dangerous drugs, and Schedules IV and V controlled substances.
Schedules II and III controlled substances may not be dispensed by
an auto-refill program.
(iv) As is required for all prescriptions, a drug regimen
review shall be completed on all prescriptions filled as a result
of the auto-refill program. Special attention shall be noted for drug
regimen review warnings of duplication of therapy and all such conflicts
shall be resolved with the prescribing practitioner prior to refilling
the prescription.
(9) Records Relating to Dispensing Errors. If a dispensing
error occurs, the following is applicable.
(A) Original prescription drug orders:
(i) shall not be destroyed and must be maintained in
accordance with subsection (a) of this section; and
(ii) shall not be altered. Altering includes placing
a label or any other item over any of the information on the prescription
drug order (e.g., a dispensing tag or label that is affixed to back
of a prescription drug order must not be affixed on top of another
dispensing tag or label in such a manner as to obliterate the information
relating to the error).
(B) Prescription drug order records maintained in a
data processing system:
(i) shall not be deleted and must be maintained in
accordance with subsection (a) of this section;
(ii) may be changed only in compliance with subsection
(e)(2)(B) of this section; and
(iii) if the error involved incorrect data entry into
the pharmacy's data processing system, this record must be either
voided or cancelled in the data processing system, so that the incorrectly
entered prescription drug order may not be dispensed, or the data
processing system must be capable of maintaining an audit trail showing
any changes made to the data in the system.
Cont'd... |