| (i) If a pharmacy is staffed by only one pharmacist,
the pharmacist may leave the prescription department for short periods
of time without closing the prescription department and removing pharmacy
technicians, pharmacy technician trainees, and other pharmacy personnel
from the prescription department provided the following conditions
are met:
(I) at least one pharmacy technician remains in the
prescription department;
(II) the pharmacist remains on-site at the licensed
location of the pharmacy and is immediately available;
(III) the pharmacist reasonably believes that the security
of the prescription department will be maintained in his or her absence.
If in the professional judgment of the pharmacist, the pharmacist
determines that the prescription department should close during his
or her absence, then the pharmacist shall close the prescription department
and remove the pharmacy technicians, pharmacy technician trainees,
and other pharmacy personnel from the prescription department during
his or her absence; and
(IV) a notice is posted which includes the following
information:
(-a-) the pharmacist is on a break and the time the
pharmacist will return; and
(-b-) pharmacy technicians may begin the processing
of prescription drug orders or refills brought in during the pharmacist's
absence, but the prescription or refill may not be delivered to the
patient or the patient's agent until the pharmacist verifies the accuracy
of the prescription.
(ii) During the time a pharmacist is absent from the
prescription department, only pharmacy technicians who have completed
the pharmacy's training program may perform the following duties,
provided a pharmacist verifies the accuracy of all acts, tasks, and
functions performed by the pharmacy technicians prior to delivery
of the prescription to the patient or the patient's agent:
(I) initiating and receiving refill authorization requests;
(II) entering prescription data into a data processing
system;
(III) taking a stock bottle from the shelf for a prescription;
(IV) preparing and packaging prescription drug orders
(e.g., counting tablets/capsules, measuring liquids, or placing them
in the prescription container);
(V) affixing prescription labels and auxiliary labels
to the prescription container;
(VI) prepackaging and labeling prepackaged drugs;
(VII) receiving oral prescription drug orders for dangerous
drugs and reducing these orders to writing, either manually or electronically;
(VIII) transferring or receiving a transfer of original
prescription information for dangerous drugs on behalf of a patient;
and
(IX) contacting a prescriber for information regarding
an existing prescription for a dangerous drug.
(iii) Upon return to the prescription department, the
pharmacist shall:
(I) conduct a drug regimen review as specified in subsection
(c)(2) of this section; and
(II) verify the accuracy of all acts, tasks, and functions
performed by the pharmacy technicians prior to delivery of the prescription
to the patient or the patient's agent.
(iv) An agent of the pharmacist may deliver a previously
verified prescription to the patient or his or her agent provided
a record of the delivery is maintained containing the following information:
(I) date of the delivery;
(II) unique identification number of the prescription
drug order;
(III) patient's name;
(IV) patient's phone number or the phone number of
the person picking up the prescription; and
(V) signature of the person picking up the prescription.
(v) Any prescription delivered to a patient when a
pharmacist is not in the prescription department must meet the requirements
for a prescription delivered to a patient as described in subsection
(c)(1)(F) of this section.
(vi) During the times a pharmacist is absent from the
prescription department a pharmacist intern shall be considered a
registered pharmacy technician and may perform only the duties of
a registered pharmacy technician.
(vii) In pharmacies with two or more pharmacists on
duty, the pharmacists shall stagger their breaks and meal periods
so that the prescription department is not left without a pharmacist
on duty.
(B) Pharmacist is off-site.
(i) The prescription department must be secured with
procedures for entry during the time that a pharmacy is not under
the continuous on-site supervision of a pharmacist and the pharmacy
is not open for pharmacy services.
(ii) Pharmacy technicians and pharmacy technician trainees
may not perform any duties of a pharmacy technician or pharmacy technician
trainee during the time that the pharmacist is off-site.
(iii) A pharmacy may use an automated dispensing and
delivery system as specified in §291.121(d) of this title for
pick-up of a previously verified prescription by a patient or patient's
agent.
(iv) An agent of the pharmacist may deliver a previously
verified prescription to a patient or patient's agent during short
periods of time when a pharmacist is off-site, provided the following
conditions are met:
(I) short periods of time may not exceed two consecutive
hours in a 24 hour period;
(II) a notice is posted which includes the following
information:
(-a-) the pharmacist is off-site and not present in
the pharmacy;
(-b-) no new prescriptions may be prepared at the pharmacy
but previously verified prescriptions may be delivered to the patient
or the patient's agent; and
(-c-) the date/time when the pharmacist will return;
(III) the pharmacy must maintain documentation of the
absences of the pharmacist(s); and
(IV) the prescription department is locked and secured
to prohibit unauthorized entry.
(v) During the time a pharmacist is absent from the
prescription department and is off-site, a record of prescriptions
delivered must be maintained and contain the following information:
(I) date and time of the delivery;
(II) unique identification number of the prescription
drug order;
(III) patient's name;
(IV) patient's phone number or the phone number of
the person picking up the prescription; and
(V) signature of the person picking up the prescription.
(vi) Any prescription delivered to a patient when a
pharmacist is not on-site at the pharmacy must meet the requirements
for a prescription delivered to a patient as described in subsection
(c)(1)(F) of this section.
(c) Prescription dispensing and delivery.
(1) Patient counseling and provision of drug information.
(A) To optimize drug therapy, a pharmacist shall communicate
to the patient or the patient's agent information about the prescription
drug or device which in the exercise of the pharmacist's professional
judgment the pharmacist deems significant, such as the following:
(i) name and description of the drug or device;
(ii) dosage form, dosage, route of administration,
and duration of drug therapy;
(iii) special directions and precautions for preparation,
administration, and use by the patient;
(iv) common severe side or adverse effects or interactions
and therapeutic contraindications that may be encountered, including
their avoidance, and the action required if they occur;
(v) techniques for self-monitoring of drug therapy;
(vi) proper storage;
(vii) refill information; and
(viii) action to be taken in the event of a missed
dose.
(B) Such communication shall be:
(i) provided to new and existing patients of a pharmacy
with each new prescription drug order. A new prescription drug order
is one that has not been dispensed by the pharmacy to the patient
in the same dosage and strength within the last year;
(ii) provided for any prescription drug order dispensed
by the pharmacy on the request of the patient or patient's agent;
(iii) communicated orally unless the patient or patient's
agent is not at the pharmacy or a specific communication barrier prohibits
such oral communication;
(iv) documented by recording the initials or identification
code of the pharmacist providing the counseling in the prescription
dispensing record as follows:
(I) on the original hard-copy prescription, provided
the counseling pharmacist clearly records his or her initials on the
prescription for the purpose of identifying who provided the counseling;
Cont'd... |
