Biological products-pharmacies.

ORIGINAL
Senate
File No
.
SF0075

ENROLLED ACT NO. 45,

SENATE

SIXTY-FOURTH LEGISLATURE OF THE STATE OF WYOMING
2018 Budget Session

AN ACT relating to pharmacy; authorizing a pharmacist to dispense specified biological products as a substitute for a prescribed drug; providing definitions; requiring specified recordkeeping relating to biological products; making conforming amendments; and providing for an effective date.

Be It Enacted by the Legislature of the State of Wyoming:

Section 1
.

W.S. 33
‑
24
‑
136(a) and (e), 33
‑
24
‑
147(a)(iv), by creating
new paragraph
s
(vi)
and (vii)
and
by renumbering (vi) as
(vi
i
i), 33
‑
24
‑
148(b), (e)(intr
o) and (g) and
33
‑
24
‑
149

are amended to read:

33
‑
24
‑
136
.

Filing memorandum of prescription; labels generally; prescription defined; counseling and patient profiles.

(a)

Every person who prepares, compounds, processes, packages or repackages, dispenses, fills or sells or offers for sale, at retail or in connection with operation of a health care facility, any prescription, shall place the written or electronic record of the prescription in a separate file marked and kept for that purpose, and shall affix a label to the container in which the prescribed substance is dispensed bearing the name and address of the pharmacy and initials of the dispensing pharmacist, or of the preceptor if the dispenser is an intern, the date on which the prescription is filed in the pharmacy's files, the name of the person who prescribed the substance, the name of the patient or customer for whom the prescription was made and directions for use by the patient as directed on the prescription by the
prescriber
practitioner
.

(e)

Notwithstanding subsection (a) of this section, if, in the opinion of the pharmacist, an emergency exists whereby the
prescriber of
practitioner who ordered or
prescribed

the prescription cannot be contacted for authorization and there is a need to refill the prescription, the pharmacist may provide up to a seventy
‑
two (72) hour supply, or the smallest available unit, of the previously prescribed drug, except a controlled substance. Nothing in this subsection shall be construed to require a pharmacist to refill the prescription in the absence of authorization from the
prescriber
practitioner
.

33
‑
24
‑
147
.

Definitions.

(a)

As used in this act:

(iv)

"Substitute" means to dispense a generically equivalent
drug or interchangeable biological
product in place of the
dangerous substance
prescription
ordered or prescribed;

(vi)

"Biological product" means as defined in 42 U.S.C. 262(i)(1)
;

(vii)

"Interchangeable biological product" means a biological product that the United States food and drug administration has:

(A)

Licensed and determined meets the standards for interchangeability under 42 U.S.C. 262(k)
(4)
; or

(B)

Determined is therapeutically equivalent to the prescription ordered or prescribed
, as set forth in the latest edition or supplement to the Approved Drug Products with Ther
apeutic Equivalence Evaluations (Orange Book) issued by the United States food and drug administration.

(vi)
(vii
i
)

"This act" means W.S. 33
‑
24
‑
146 through 33
‑
24
‑
151.

33
‑
24
‑
148
.

Conditions for drug substitution.

(b)

Except as limited by W.S. 33
‑
24
‑
149(b) or when the practitioner has clearly indicated substitution is not permitted, a pharmacist may substitute
:

(
i
)

A
drug product with the same generic name in the identical strength, quantity, dose and dosage form as the prescribed drug, provided the substituted
product or

drug meets all requirements specified in W.S. 33
‑
24
‑
147(a)(ii)
;
.

(ii)

An interchangeable biological product.

(e)

A pharmacist may not substitute a
generically equivalent
drug
product
unless it has been manufactured with the following minimum manufacturing standards and practices by a manufacturer who:

(g)

When a practitioner orally communicates a prescription and prohibits
a
generic
substitution
of an interchangeable biological product or

generically equivalent drug
, the pharmacist shall make reasonable efforts to obtain a written prescription from the practitioner with the phrase "brand medically necessary" written on the face of the prescription in his own handwriting.

33
‑
24
‑
149
.

Drug substitution procedures.

(a)

A pharmacist who receives a prescription for a brand name prescription drug may dispense any
interchangeable biological product or

generically equivalent drug of the brand name prescription drug prescribed, unless the prescribing practitioner has clearly indicated substitution is not permitted.

(b)

If a practitioner prescribes a prescription drug by its generic name
or by the nonproprietary name of an interchangeable biological product
, the pharmacist may dispense the generically equivalent drug
or the interchangeable biological product
as defined in this act.

(c)

Except as provided in subsection (e) of this section, when a pharmacist dispenses
a substituted drug
an interchangeable biological product or generically equivalent drug

as authorized by this act, he shall label the prescription container with the name of the dispensed
biological product or
drug. If the dispensed drug
or product

does not have a brand name, the prescription label shall indicate the generic name of the drug dispensed
or
the nonproprietary name of the interchangeable biological product dispensed
.

(d)

The national drug code number or the name of the manufacturer or distributor of the
generic drug
interchangeable biological product or generically equivalent drug

dispensed shall be noted on the prescription record
or entry

by the pharmacist.

(e)

A prescription dispensed by a pharmacist shall bear upon the label the name of the medication in the container except if the
prescriber
practitioner

orders "do not label", or words of similar import, on the prescription or so designates in an oral or electronic transmission of the prescription.

(f)

Except as otherwise provided in subsection
s

(g
)
and (j)
of this section, n
ot later than five (5) business days after dispensing a biological product, the dispensing pharmacist or
the pharmacist's
designee shall
make an entry

of
the specific product
dispensed
to the patient, including the name and manufacturer of the product
. The entry shall
be electronically accessible to the practitioner through one
(1)
of
the following

electronic records systems:

(i)

An interoperable electronic medical records system;

(ii)

Electronic prescribing technology;

(iii)

A pharmacy benefit management system; or

(iv)

A pharmacy record.

(g
)

Except as oth
erwise provided in subsection (j
) of this section, i
f an electronic records system under subsection (f)
of this section
is not available,
the dispensing pharmacist shall, not later than five (5) business days after dispensing a biological product,
communicate
to the practitioner the specific product
dispensed
to the patient, including the name
and manufacturer of the product, using facsimile, telephone, electronic transmission or
any
other prevailing means of communication.

(h)

An entry made into an electronic records system under subsection (f) of this section or a communication made under subsection (g) of this section shall establish a presumption that the practitioner received notice of the biological product dispensed to the patient.

(j
)

The requirements of subsection
s
(f) and (g
)
of this section
shall not apply

if
:

(i)

There is no

interchangeable biological product for the product prescribed
by the practitioner
; or

(ii)

A prescription
for a refill is not changed from the product dispensed on the prior filling of the prescription
.

(k)

The dispensing pharmacist shall notify a patient of the
biological
product which was dispensed,
which may be
carried out
through the
prescription label required
pursuant
subsection (c) of this section.

Section 2
.

This act is effective July 1, 201
8
.

(END)

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