June 16, 2004, Introduced by Reps. Pumford, Hart, Woronchak, Newell, Caul, Ruth Johnson, Pappageorge, Rocca, Kolb, LaSata, Stewart, Koetje, Emmons, Drolet, Acciavatti, Bradstreet, Milosch, Stahl, Farhat and Caswell and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 17766 (MCL 333.17766), as amended by 1990 PA
30, and by adding section 17766d.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
1 Sec. 17766. Except
as provided in section 17766a 17766d,
2 a person who does any of the following is guilty of a
3 misdemeanor:
4 (a) Obtains or attempts to obtain a prescription drug by
5 giving a false name to a pharmacist or other authorized seller,
6 prescriber, or dispenser.
7 (b) Obtains or attempts to obtain a prescription drug by
8 falsely representing that he or she is a lawful prescriber,
9 dispenser, or licensee, or acting on behalf of a lawful
10 prescriber, dispenser, or licensee.
1 (c) Falsely makes, utters, publishes, passes, alters, or
2 forges a prescription.
3 (d) Knowingly possesses a false, forged, or altered
4 prescription.
5 (e) Knowingly attempts to obtain, obtains, or possesses a
6 drug by means of a prescription for other than a legitimate
7 therapeutic purpose, or as a result of a false, forged, or
8 altered prescription.
9 (f) Possesses or controls for the purpose of resale, or
10 sells, offers to sell, dispenses, or gives away, a drug,
11 pharmaceutical preparation, or chemical that has been dispensed
12 on prescription and has
left the control of a pharmacist. , or
13 (g) Possesses or controls for the purpose of resale, or
14 sells, offers to sell, dispenses, or gives away, a drug,
15 pharmaceutical preparation, or chemical that has been damaged by
16 heat, smoke, fire, water, or other cause and is unfit for human
17 or animal use.
18 (h) (g) Prepares
or permits the preparation of a
19 prescription drug, except as delegated by a pharmacist.
20 (i) (h) Sells
a drug in bulk or in an open package at
21 auction, unless the sale has been approved in accordance with
22 rules of the board.
23 Sec. 17766d. (1) Notwithstanding section 17766(f), a
24 pharmacy may accept for the purpose of resale or redispensing a
25 prescription drug that has been dispensed and has left the
26 control of the pharmacist if the prescription drug is being
27 returned from a facility that has a registered professional nurse
1 or a licensed practical nurse who is responsible for the
2 security, handling, and administration of prescription drugs
3 within that facility and if all of the following are met:
4 (a) The pharmacist is satisfied that the conditions under
5 which the prescription drug has been delivered, stored, and
6 handled before and during its return were such as to prevent
7 damage, deterioration, or contamination that would adversely
8 affect the identity, strength, quality, purity, stability,
9 integrity, or effectiveness of the prescription drug.
10 (b) The pharmacist is satisfied that the prescription drug
11 did not leave the control of the registered professional nurse or
12 licensed practical nurse responsible for the security, handling,
13 and administration of that prescription drug and that the
14 prescription drug did not come into the physical possession of
15 the individual for whom it was prescribed.
16 (c) The pharmacist is satisfied that the labeling and
17 packaging of the prescription drug are accurate, have not been
18 altered, defaced, or tampered with, and include the identity,
19 strength, expiration date, and lot number of the prescription
20 drug.
21 (d) The prescription drug was dispensed in a unit dose
22 package or unit of issue package.
23 (2) A pharmacy shall not accept for return prescription drugs
24 under this section until the pharmacist in charge develops a
25 written set of protocols for accepting, returning to stock,
26 repackaging, labeling, and redispensing prescription drugs. The
27 written protocols shall be maintained on the premises and shall
1 be readily accessible to each pharmacist on duty. The written
2 protocols shall include, at a minimum, each of the following:
3 (a) Methods to ensure that damage, deterioration, or
4 contamination has not occurred during the delivery, handling,
5 storage, and return of the prescription drugs which would
6 adversely affect the identity, strength, quality, purity,
7 stability, integrity, or effectiveness of those prescription
8 drugs or otherwise render those drugs unfit for distribution.
9 (b) Methods for accepting, returning to stock, repackaging,
10 labeling, and redispensing the prescription drugs returned under
11 this section.
12 (c) A uniform system of recording and tracking prescription
13 drugs that are returned to stock, repackaged, labeled, and
14 redistributed under this section.
15 (3) If the integrity of a prescription drug and its package
16 is maintained, a prescription drug returned under this section
17 shall be returned to stock and redistributed as follows:
18 (a) A prescription drug that was originally dispensed in the
19 manufacturer's unit dose package or unit of issue package and is
20 returned in that same package may be returned to stock,
21 repackaged, and redispensed as needed.
22 (b) A prescription drug that is repackaged into a unit dose
23 package or a unit of issue package by the pharmacy, dispensed,
24 and returned to that pharmacy in that unit dose package or unit
25 of issue package may be returned to stock, but it shall not be
26 repackaged. A unit dose package or unit of issue package
27 prepared by the pharmacist and returned to stock shall only be
1 redispensed in that same unit dose package or unit of issue
2 package and shall only be redispensed once. A pharmacist shall
3 not add unit dose package drugs to a partially used unit of issue
4 package.
5 (4) This section does not apply to any of the following:
6 (a) A controlled substance.
7 (b) A prescription drug that is dispensed as part of a
8 customized patient medication package.
9 (c) A prescription drug that is not dispensed as a unit dose
10 package or a unit of issue package.
11 (d) A prescription drug that is not properly labeled with the
12 identity, strength, lot number, and expiration date.
13 (e) A prescription drug that is dispensed in a medical
14 institution and returned to stock for redistribution in
15 accordance with R 338.486 of the Michigan administrative code.
16 (5) A prescription drug that was prepared and packaged
17 pursuant to a prescription but did not leave the control of the
18 pharmacist may be returned to stock for redispensing in
19 accordance with this section if the prescription drug has not
20 expired and was stored with the original prescription label and
21 in the form in which it was prepared and packaged. A record
22 shall be made indicating that the prescription drug has been
23 returned to stock and the date of the return. Unless the
24 prescription drug was originally dispensed in a unit dose package
25 or unit of issue package and the expiration date is included on
26 that package, a prescription drug that is returned to stock under
27 this subsection shall be redispensed with a label bearing the
1 same expiration date as on the original label.
2 (6) As used in this section:
3 (a) "Customized patient medication package" means a package
4 that is prepared by a pharmacist for a specific patient that
5 contains 2 or more prescribed solid oral dosage forms.
6 (b) "Repackage" means a process by which the pharmacy
7 prepares a unit dose package, unit of issue package, or
8 customized patient medication package for immediate dispensing
9 pursuant to a current prescription.
10 (c) "Unit dose package" means a package that contains a
11 single dose drug with the name, strength, control number, and
12 expiration date of that drug on the label.
13 (d) "Unit of issue package" means a package that provides
14 multiple doses of the same drug, but each drug is individually
15 separated and includes the name, lot number, and expiration date.