Subpart 1.
Duties.
The practice of compounding and dispensing a prescription
drug order includes, but is not limited to, the following acts, which shall be
performed only by a pharmacist, practitioner, or pharmacist-intern under the
immediate and direct supervision of a pharmacist:
A. determination of brands and
suppliers;
B. receipt of verbal
prescription drug orders which must include documentation of the individual
communicating the order and the pharmacist or pharmacist intern receiving the
order;
C. verification of the
prescription drug order;
D.
selection of the drug to be used in filling the prescription drug
order;
E. establishment and
validation of the initial formulation record of all compounded preparations
according to part
6800.3300;
F. certification of the filled prescription
drug order;
G. ensuring that, when
required by law or by the best professional practice, permission to refill is
obtained from authorized practitioners or other individuals allowed to
prescribe legend drugs according to Minnesota Statutes, section
151.37,
subdivision 2, and then noting on the reverse side of the prescription drug
order or in the electronically maintained record of the prescription drug order
the following data: date refilled; name of practitioner or other authorized
prescriber personally authorizing the refill, and the name of the
practitioner's agent transmitting or communicating the refill authorization, if
applicable; quantity of drug dispensed, if different from the original
prescription; and the unique identifier of the pharmacist refilling the
prescription;
H. supervising
clerical personnel in limited nonprofessional duties such as typing that does
not involve prescription data entry, record keeping, filing, and completing
sales transactions; and
I.
supervising pharmacy technicians utilized in the performance of certain
pharmacy tasks not requiring professional judgment in accordance with part
6800.3850.
Subp. 2.
Verification.
Verification of validity and propriety under subpart
1, item C, must be of the
original prescription drug order. A rewritten, verbal, or electronically
produced copy is not acceptable except as provided in parts
6800.3000, subpart
2, 6800.3120, subpart 7, and
6800.3950, subpart 1a.
Subp.
3.
Certification.
In certifying and documenting the filled prescription under
subpart
1, item F, an individual
pharmacist, practitioner, or pharmacist-intern shall:
A. check the original labeled container from
which the medication was withdrawn, except as provided in part
6800.2600, or when the pharmacy
uses a computerized process to identify oral, solid drugs through the use of
images;
B. check the labeling on
the medication container that will be dispensed;
C. check the contents of the medication
container that will be dispensed and the appearance of the total product to
ensure that all of the doses that are dispensed are of the correct drug,
strength, and dosage form prescribed;
D. review the patient's medication profile
for purposes of conducting a prospective drug review and checking the accuracy
of the addition to the profile of the medication dispensed; and
E. place the pharmacist's, practitioner's, or
pharmacist-intern's unique identifier on the prescription drug order or other
permanently maintained record. Those pharmacists using automated medication
management dispensing systems must develop written policies and procedures
which provide that all certification steps are performed and documented before
the medication is dispensed to the patient. These policies and procedures must
be made available for inspection by the board upon request.
Subp. 3a.
Accountability.
For prescriptions filled in a pharmacy, the unique identifier
of each pharmacist, pharmacist-intern, or pharmacy technician who performs any
portion of the prescription filling process must be documented, with the
documentation maintained for a minimum of two years. The documentation must
indicate which portion of the prescription filling process each pharmacist,
pharmacist-intern, or pharmacy technician completed. For prescriptions filled
by a practitioner, the unique identifier of each practitioner and each
individual who assists the practitioner according to part
6800.9952 must be documented and
the documentation maintained for a minimum of two years. This subpart does not
waive the requirement for an individual pharmacist, practitioner, or
pharmacist-intern to certify a filled prescription drug order according to
subpart
3.
Subp. 3b.
Notice required.
A pharmacy utilizing a central service pharmacy to provide
dispensing functions, drug utilization review, packaging, labeling, delivery of
a filled prescription, or other services must notify the pharmacy's patients of
that fact.
Subp. 4.
Exception.
This part applies to all pharmacies. Provided, however, that
nothing in this part prevents pharmacists in hospitals from dispensing to
hospital inpatients according to parts
6800.7100 to
6800.7950.
