Bill Text: IA SF2298 | 2017-2018 | 87th General Assembly | Enrolled
Bill Title: A bill for an act relating to pharmacy regulation, including the composition of the board of pharmacy and the wholesale distribution of prescription drugs and devices, and including penalties. (Formerly SSB 3072.) Effective 7-1-18.
Spectrum: Committee Bill
Status: (Passed) 2018-05-16 - Signed by Governor. S.J. 1087. [SF2298 Detail]
Download: Iowa-2017-SF2298-Enrolled.html
Senate File 2298 - Enrolled
SENATE FILE
BY COMMITTEE ON HUMAN
RESOURCES
(SUCCESSOR TO SSB
3072)
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A BILL FOR
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Senate File 2298
AN ACT
RELATING TO PHARMACY REGULATION, INCLUDING THE
COMPOSITION OF THE BOARD OF PHARMACY AND THE WHOLESALE
DISTRIBUTION OF PRESCRIPTION DRUGS AND DEVICES, AND
INCLUDING PENALTIES.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
Section 1. Section 147.14, subsection 1, paragraph e, Code
2018, is amended to read as follows:
e. For pharmacy, five members licensed to practice pharmacy,
one member registered as a certified pharmacy technician as
defined by the board by rule, and two members who are not
licensed to practice pharmacy or registered as a certified
pharmacy technician and who shall represent the general public.
Sec. 2. Section 155A.3, subsection 11, Code 2018, is amended
to read as follows:
11. "Device" means an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other
similar or related article, including any component part or
accessory, a medical device, as classified by the United States
food and drug administration, intended for use by a patient
that is required under federal or state law by the United
States food and drug administration to be ordered or prescribed
for a patient by a practitioner.
Sec. 3. Section 155A.3, subsection 14, Code 2018, is amended
by striking the subsection.
Sec. 4. Section 155A.3, subsection 25, Code 2018, is amended
to read as follows:
25. "Limited drug and device distributor" means a person
operating or maintaining, either within or outside this state,
a location at which limited noncontrolled, regardless of the
location, where prescription drugs, prescription or devices,
and medical gases, are distributed to patients in this state
pursuant to a prescription drug order; or a person operating or
maintaining a location at which limited quantities of drugs,
devices, or medical gases are distributed at wholesale in this
state or to a patient pursuant to a prescription drug order,
who is not eligible for a wholesale distributor license or
pharmacy license. A "limited drug and device distributor" does
not include a pharmacy licensed pursuant to this chapter or a
drug wholesaler providing prescription drugs to patients in
this state pursuant to a drug manufacturer's prescription drug
assistance program.
Sec. 5. Section 155A.3, subsection 26, Code 2018, is amended
by striking the subsection.
Sec. 6. Section 155A.3, Code 2018, is amended by adding the
following new subsections:
NEW SUBSECTION. 27A. "Manufacturer" means manufacturer
as defined by the federal Drug Supply Chain Security Act, 21
U.S.C. {360eee et seq.
NEW SUBSECTION. 27B. "Medical convenience kit" means
a collection of devices, which may include a product or
biological product, assembled in kit form strictly for the
convenience of the purchaser or ultimate user.
NEW SUBSECTION. 41A. "Product" means the same as defined in
21 U.S.C. {360eee.
NEW SUBSECTION. 42A. "Repackager" means a person who owns
or operates an establishment that repackages or relabels a
product or package for further sale or for distribution without
a further transaction.
NEW SUBSECTION. 45A. "Third=party logistics provider" means
an entity that provides or coordinates warehousing or other
logistics services of a product in interstate commerce on
behalf of a manufacturer, wholesale distributor, or dispenser
of a product, but does not take ownership of the product nor
have responsibility to direct the sale or other disposition of
the product.
Sec. 7. Section 155A.3, subsection 40, Code 2018, is amended
by striking the subsection and inserting in lieu thereof the
following:
40. "Prescription drug" or "drug" means a drug, as
classified by the United States food and drug administration,
that is required by the United States food and drug
administration to be prescribed or administered to a patient by
a practitioner prior to dispensation.
Sec. 8. Section 155A.3, subsection 48, Code 2018, is amended
by striking the subsection and inserting in lieu thereof the
following:
48. "Wholesale distribution" means the distribution of
a drug to a person other than a consumer or patient, or the
receipt of a drug by a person other than a consumer or patient,
but does not include any of the following:
a. Intracompany distribution of any drug between members
of an affiliate, as defined in 21 U.S.C. {360eee, or within a
manufacturer.
b. The distribution of a drug, or an offer to distribute a
drug among hospitals or other health care entities under common
control.
c. The distribution of a drug or an offer to distribute a
drug for emergency medical reasons, including a public health
emergency declaration as defined in 42 U.S.C. {247d, except
that for purposes of this paragraph a drug shortage not caused
by a public health emergency shall not constitute an emergency
medical reason.
d. The dispensing of a drug pursuant to a prescription drug
order.
e. The distribution of minimal quantities of a drug by a
pharmacy to a practitioner for office use.
f. The distribution of a drug or an offer to distribute a
drug by a charitable organization to an affiliate, as defined
in 21 U.S.C. {360eee, of the organization that is a nonprofit,
to the extent otherwise permitted by law.
g. The purchase or other acquisition of a drug by a
dispenser, as defined in 21 U.S.C. {360eee, hospital, or other
health care entity for use by such dispenser, hospital, or
other health care entity.
h. The distribution of a drug by the manufacturer of such
drug.
i. The receipt or transfer of a drug by a third=party
logistics provider, provided that such third=party logistics
provider does not take ownership of the drug.
j. A common carrier that transports a drug, provided that
the common carrier does not take ownership of the drug.
k. The distribution of a drug or an offer to distribute a
drug by a repackager that has taken ownership or possession of
the drug and repackages it.
l. The return of a saleable product when conducted by a
dispenser.
m. The distribution of a medical convenience kit under any
of the following circumstances:
(1) The medical convenience kit is assembled in an
establishment registered with the United States food and drug
administration as a device manufacturer.
(2) The medical convenience kit does not contain a
controlled substance.
(3) In the case of a medical convenience kit that includes
a product, the person that manufacturers the kit does all of
the following:
(a) Purchases the product directly from a pharmaceutical
manufacturer or from a wholesale distributor that purchased the
product directly from the pharmaceutical manufacturer.
(b) Does not alter the primary container or label of
the product as purchased from the manufacturer or wholesale
distributor.
(4) In the case of a medical convenience kit that includes a
product, the product is any of the following:
(a) An intravenous solution intended for the replenishment
of fluids and electrolytes.
(b) Intended to maintain the equilibrium of water and
minerals in the body.
(c) Intended for irrigation or reconstitution.
(d) An anesthetic.
(e) An anticoagulant.
(f) A vasopressor.
(g) A sympathomimetic.
n. The distribution of an intravenous drug that by its
formulation is intended for the replenishment of fluids and
electrolytes such as sodium, chloride, and potassium, or
calories such as dextrose and amino acids.
o. The distribution of an intravenous drug used to maintain
the equilibrium of water and minerals in the body such as a
dialysis solution.
p. The distribution of a drug intended for irrigation or
sterile water intended for irrigation or for injection.
q. The distribution of a medical gas.
r. The facilitation of the distribution of a product by
providing administrative services, including the processing of
orders and payments.
s. The transfer of a product by a hospital or other health
care entity, or by a wholesale distributor or manufacturer
operating at the direction of the hospital or other health care
entity, to a repackager for the purpose of repackaging the
product for use by that hospital or other health care entity
under common control, if the ownership of the product remains
with the hospital or other health care entity at all times.
Sec. 9. Section 155A.3, subsection 49, Code 2018, is amended
by striking the subsection and inserting in lieu thereof the
following:
49. "Wholesale distributor" means a person, other than
a manufacturer, a manufacturer's co=licensed partner, a
third=party logistics provider, or repackager, engaged in the
wholesale distribution of a drug.
Sec. 10. Section 155A.4, subsection 2, paragraph a, Code
2018, is amended to read as follows:
a. A wholesaler limited distributor, third=party logistics
provider, or wholesale distributor to distribute prescription
drugs or devices as provided by state or federal law.
Sec. 11. Section 155A.4, subsection 2, paragraph h, Code
2018, is amended by striking the paragraph.
Sec. 12. Section 155A.5, Code 2018, is amended to read as
follows:
155A.5 Injunction.
Notwithstanding the existence or pursuit of any other remedy
the board may, in the manner provided by law, maintain an
action in the name of the state for injunction or other process
against any person to restrain or prevent the establishment,
conduct, management, or operation of a pharmacy or wholesaler,
limited distributor, third=party logistics provider, or
wholesale distributor without a license, or to prevent the
violation of provisions of this chapter. Upon request of
the board, the attorney general shall institute the proper
proceedings and the county attorney, at the request of the
attorney general, shall appear and prosecute the action when
brought in the county attorney's county.
Sec. 13. Section 155A.17, Code 2018, is amended by striking
the section and inserting in lieu thereof the following:
155A.17 Wholesale distributor license.
1. A person shall not engage in wholesale distribution
without a wholesale distributor license.
2. Wholesale distributors shall comply with the national
standards contained in the federal Drug Supply Chain Security
Act, 21 U.S.C. {360eee et seq., and national standards
promulgated thereunder.
3. The board shall adopt rules establishing requirements
for wholesale distributor licenses, licensure fees, and other
relevant matters consistent with the federal Drug Supply Chain
Security Act, 21 U.S.C. {360eee et seq.
4. The board may deny, suspend, or revoke a wholesale
distributor license, or otherwise discipline a wholesale
distributor, for failure to meet the applicable standards or
for a violation of the laws of this state, another state, or
the United States, or for a violation of this chapter, chapter
124, 124B, 126, or 205, or a rule of the board.
Sec. 14. NEW SECTION. 155A.17A Third=party logistics
provider license.
1. A person shall not operate as a third=party logistics
provider in this state without a third=party logistics provider
license.
2. Third=party logistics providers shall comply with
national standards contained in the federal Drug Supply Chain
Security Act, 21 U.S.C. {360eee et seq., and national standards
promulgated thereunder.
3. The board shall adopt rules establishing requirements
for a third=party logistics provider license, licensure fees,
and other relevant matters consistent with the federal Drug
Supply Chain Security Act, 21 U.S.C. {360eee et seq.
4. The board may deny, suspend, or revoke a third=party
logistics provider license, or otherwise discipline a
third=party logistics provider, for failure to meet the
applicable standards or for a violation of the laws of this
state, another state, or the United States, or for a violation
of this chapter, chapter 124, 124B, 126, or 205, or a rule of
the board.
Sec. 15. Section 155A.42, Code 2018, is amended to read as
follows:
155A.42 Limited drug and device distributor license.
1. A person other than a wholesale distributor, licensed
pharmacy, or practitioner, shall not act as a limited drug and
device distributor engage in any of the following activities in
this state without a limited distributor license. The license
shall be identified as a limited drug and device distributor
license.:
a. Distribution of a medical gas or device at wholesale or
to a patient pursuant to a prescription drug order.
b. Wholesale distribution of a prescription animal drug.
c. Wholesale distribution of a prescription drug, or
brokering the distribution of a prescription drug at wholesale,
by a manufacturer, a manufacturer's co=licensed partner, or a
repackager.
d. Intracompany distribution of a prescription drug,
including pharmacy chain distribution centers.
e. Distribution at wholesale of a combination product as
defined by the United States food and drug administration,
medical convenience kit, intravenous fluid or electrolyte,
dialysis solution, radioactive drug, or irrigation or sterile
water solution to be dispensed by prescription only.
f. Distribution of a dialysis solution by the manufacturer
or the manufacturer's agent to a patient pursuant to a
prescription drug order, provided that a licensed pharmacy
processes the prescription drug order.
2. The board shall establish, by rule, adopt rules
establishing the requirements for a limited distributor
license, licensure fees, compliance standards for limited
drug and device distributors and may define specific types
of limited drug and device distributors, and any other
relevant matters. The board may identify, by rule, specific
prescription drugs or classes of noncontrolled prescription
drugs, which may be distributed by a limited drug and device
distributor. A limited distributor shall not be required to
have an onsite pharmacist.
3. The board shall adopt rules pursuant to chapter
17A relating to the issuance of a limited drug and device
distributor license. The rules shall provide for conditions of
licensure, compliance standards, licensure fees, disciplinary
action, and other relevant matters.
4. 3. The board may deny, suspend, or revoke a limited
drug and device distributor's license, or otherwise discipline
a limited distributor, for failure to meet the applicable
standards or for a violation of the laws of this state, another
state, or the United States relating to prescription drugs or
controlled substances, or for a violation of this chapter,
chapter 124, 124B, 126, or 205, or 272C, or a rule of the board.
CHARLES SCHNEIDE
LINDA UPMEYER
W. CHARLES SMITH
KIM REYNOLDS
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