March 15, 2005, Introduced by Reps. Bieda and Condino and referred to the Committee on Senior Health, Security, and Retirement.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 17766 and 21413 (MCL 333.17766 and 333.21413),
section 17766 as amended by 2004 PA 329 and section 21413 as
amended by 1996 PA 267, and by adding section 17766e.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17766. Except as provided in section 17766d or 17766e, a
person who does any of the following is guilty of a misdemeanor:
(a) Obtains or attempts to obtain a prescription drug by
giving a false name to a pharmacist or other authorized seller,
prescriber, or dispenser.
(b) Obtains or attempts to obtain a prescription drug by
falsely representing that he or she is a lawful prescriber,
dispenser, or licensee, or acting on behalf of a lawful prescriber,
dispenser, or licensee.
(c) Falsely makes, utters, publishes, passes, alters, or
forges a prescription.
(d) Knowingly possesses a false, forged, or altered
prescription.
(e) Knowingly attempts to obtain, obtains, or possesses a drug
by means of a prescription for other than a legitimate therapeutic
purpose, or as a result of a false, forged, or altered
prescription.
(f) Possesses or controls for the purpose of resale, or sells,
offers to sell, dispenses, or gives away, a drug, pharmaceutical
preparation, or chemical that has been dispensed on prescription
and has left the control of a pharmacist.
(g) Possesses or controls for the purpose of resale, or sells,
offers to sell, dispenses, or gives away, a drug, pharmaceutical
preparation, or chemical that has been damaged by heat, smoke,
fire, water, or other cause and is unfit for human or animal use.
(h) Prepares or permits the preparation of a prescription
drug, except as delegated by a pharmacist.
(i) Sells a drug in bulk or in an open package at auction,
unless the sale has been approved in accordance with rules of the
board.
Sec. 17766e. (1) Notwithstanding section 17766(f), a pharmacy
may accept for the purpose of resale or redispensing a prescription
drug that has been dispensed and has left the control of the
pharmacist if the prescription drug is being returned by a hospice
residence licensed under article 17 that has a registered
professional nurse or a licensed practical nurse who is responsible
for the security, handling, and administration of prescription
drugs within that hospice facility and if all of the following are
met:
(a) The pharmacist is satisfied that the conditions under
which the prescription drug has been delivered, stored, and handled
before and during its return were such as to prevent damage,
deterioration, or contamination that would adversely affect the
identity, strength, quality, purity, stability, integrity, or
effectiveness of the prescription drug.
(b) The pharmacist is satisfied that the prescription drug did
not leave the control of the registered professional nurse or
licensed practical nurse responsible for the security, handling,
and administration of that prescription drug and that the
prescription drug did not come into the physical possession of the
individual for whom it was prescribed.
(c) The pharmacist is satisfied that the labeling and
packaging of the prescription drug are accurate, have not been
altered, defaced, or tampered with, and include the identity,
strength, expiration date, and lot number of the prescription drug.
(d) The prescription drug was dispensed in a unit dose package
or unit of issue package.
(2) A pharmacy shall not accept for return prescription drugs
as provided under this section until the pharmacist in charge
develops a written set of protocols for accepting, returning to
stock, repackaging, labeling, and redispensing prescription drugs.
The written protocols shall be maintained on the premises and shall
be readily accessible to each pharmacist on duty. The written
protocols shall include, at a minimum, each of the following:
(a) Methods to ensure that damage, deterioration, or
contamination has not occurred during the delivery, handling,
storage, and return of the prescription drugs which would adversely
affect the identity, strength, quality, purity, stability,
integrity, or effectiveness of those prescription drugs or
otherwise render those drugs unfit for distribution.
(b) Methods for accepting, returning to stock, repackaging,
labeling, and redispensing the prescription drugs returned under
this section.
(c) A uniform system of recording and tracking prescription
drugs that are returned to stock, repackaged, labeled, and
redistributed under this section.
(3) If the integrity of a prescription drug and its package is
maintained, a prescription drug returned under this section shall
be returned to stock and redistributed as follows:
(a) A prescription drug that was originally dispensed in the
manufacturer's unit dose package or unit of issue package and is
returned in that same package may be returned to stock, repackaged,
and redispensed as needed.
(b) A prescription drug that is repackaged into a unit dose
package or a unit of issue package by the pharmacy, dispensed, and
returned to that pharmacy in that unit dose package or unit of
issue package may be returned to stock, but it shall not be
repackaged. A unit dose package or unit of issue package prepared
by the pharmacist and returned to stock shall only be redispensed
in that same unit dose package or unit of issue package and shall
only be redispensed once. A pharmacist shall not add unit dose
package drugs to a partially used unit of issue package.
(4) This section does not apply to any of the following:
(a) A controlled substance.
(b) A prescription drug that is dispensed as part of a
customized patient medication package.
(c) A prescription drug that is not dispensed as a unit dose
package or a unit of issue package.
(d) A prescription drug that is not properly labeled with the
identity, strength, lot number, and expiration date.
(e) A prescription drug that is dispensed in a medical
institution and returned to stock for redistribution in accordance
with R 338.486 of the Michigan administrative code.
(5) As used in this section:
(a) "Customized patient medication package" means a package
that is prepared by a pharmacist for a specific patient that
contains 2 or more prescribed solid oral dosage forms.
(b) "Hospice residence" means that term as defined under
section 21401.
(c) "Repackage" means a process by which the pharmacy prepares
a unit dose package, unit of issue package, or customized patient
medication package for immediate dispensing pursuant to a current
prescription.
(d) "Unit dose package" means a package that contains a single
dose drug with the name, strength, control number, and expiration
date of that drug on the label.
(e) "Unit of issue package" means a package that provides
multiple doses of the same drug, but each drug is individually
separated and includes the name, lot number, and expiration date.
Sec. 21413. (1) The owner, operator, and governing body of a
hospice or hospice residence licensed under this article:
(a) Are responsible for all phases of the operation of the
hospice or hospice residence and for the quality of care and
services rendered by the hospice or hospice residence.
(b) Shall cooperate with the department in the enforcement of
this part, and require that the physicians and other personnel
working in the hospice or hospice residence and for whom a license
or registration is required be currently licensed or registered.
(c) Shall not discriminate because of race, religion, color,
national origin, or sex, in the operation of the hospice or hospice
residence including employment, patient admission and care, and
room assignment.
(2) As a condition of licensure as a hospice residence, an
applicant shall have been licensed under this article as a hospice
and
in compliance with the standards set forth in 42 C.F.R. CFR
part 418 for not less than the 2 years immediately preceding the
date of application for licensure. A hospice residence licensed
under this article may provide both home care and inpatient care at
the same location. A hospice residence providing inpatient care
shall
comply with the standards in 42 C.F.R. CFR 418.100.
(3) In addition to the requirements of subsections (1) and (2)
and section 21415, the owner, operator, and governing body of a
hospice residence that is licensed under this article and that
provides care only at the home care level shall do all of the
following:
(a) Provide 24-hour nursing services for each patient in
accordance with the patient's hospice care plan as required under
42
C.F.R. CFR part 418.
(b) Have an approved plan for infection control that includes
making provisions for isolating each patient with an infectious
disease.
(c) Obtain fire safety approval pursuant to section 20156.
(d) Equip each patient room with a device approved by the
department for calling the staff member on duty.
(e) Design and equip areas within the hospice residence for
the comfort and privacy of each patient and his or her family
members.
(f) Permit patients to receive visitors at any hour, including
young children.
(g) Provide individualized meal service plans in accordance
with
42 C.F.R. CFR 418.100(j).
(h) Provide appropriate methods and procedures for the
storage,
dispensing, and administering,
and disposal or return of
drugs
and biologicals pursuant to 42 C.F.R. CFR 418.100(k).