Citations Affected: IC 4-6-2-12; IC 25-26-13-4; IC 35-48-4.
Synopsis: Sale and purchase of pseudoephedrine and ephedrine.
Requires the attorney general to enter into a memorandum of
understanding with an entity to provide a pseudoephedrine (PSE)
tracking system that meets certain standards. Requires a retailer to
electronically transmit certain information concerning the sale of
ephedrine and PSE to a statewide PSE tracking system. Requires the
board of pharmacy to adopt certain rules concerning a pharmacy that
does not comply with PSE tracking requirements. Provides that a
retailer must begin entering data into the PSE tracking system not later
than 180 days after the attorney general enters into the memorandum
of understanding. Provides that an exemption to the tracking
requirement for persons who do not sell exclusively to walk-in
customers applies only to persons who do not sell to any walk-in
customers. Requires the state police to report to the legislative council
concerning the effectiveness of PSE tracking in reducing the illicit
production of methamphetamine. (The introduced version of this bill
was prepared by the criminal law and sentencing policy study
committee.)
Effective: January 1, 2012.
January 20, 2011, read first time and referred to Committee on Courts and Criminal Code.
A BILL FOR AN ACT to amend the Indiana Code concerning
criminal law and procedure.
chapter;
(4) regulate the sale of drugs and devices in the state of Indiana;
(5) impound, embargo, confiscate, or otherwise prevent from
disposition any drugs, medicines, chemicals, poisons, or devices
which by inspection are deemed unfit for use or would be
dangerous to the health and welfare of the citizens of the state of
Indiana; the board shall follow those embargo procedures found
in IC 16-42-1-18 through IC 16-42-1-31, and persons may not
refuse to permit or otherwise prevent members of the board or
their representatives from entering such places and making such
inspections;
(6) prescribe minimum standards with respect to physical
characteristics of pharmacies, as may be necessary to the
maintenance of professional surroundings and to the protection of
the safety and welfare of the public;
(7) subject to IC 25-1-7, investigate complaints, subpoena
witnesses, schedule and conduct hearings on behalf of the public
interest on any matter under the jurisdiction of the board;
(8) prescribe the time, place, method, manner, scope, and subjects
of licensing examinations which shall be given at least twice
annually; and
(9) perform such other duties and functions and exercise such
other powers as may be necessary to implement and enforce this
chapter.
(b) The board shall adopt rules under IC 4-22-2 for the following:
(1) Establishing standards for the competent practice of
pharmacy.
(2) Establishing the standards for a pharmacist to counsel
individuals regarding the proper use of drugs.
(3) Establishing standards and procedures before January 1, 2006,
to ensure that a pharmacist:
(A) has entered into a contract that accepts the return of
expired drugs with; or
(B) is subject to a policy that accepts the return of expired
drugs of;
a wholesaler, manufacturer, or agent of a wholesaler or
manufacturer concerning the return by the pharmacist to the
wholesaler, the manufacturer, or the agent of expired legend drugs
or controlled drugs. In determining the standards and procedures,
the board may not interfere with negotiated terms related to cost,
expenses, or reimbursement charges contained in contracts
between parties, but may consider what is a reasonable quantity
of a drug to be purchased by a pharmacy. The standards and
procedures do not apply to vaccines that prevent influenza,
medicine used for the treatment of malignant hyperthermia, and
other drugs determined by the board to not be subject to a return
policy. An agent of a wholesaler or manufacturer must be
appointed in writing and have policies, personnel, and facilities
to handle properly returns of expired legend drugs and controlled
substances.
(c) The board may grant or deny a temporary variance to a rule it
has adopted if:
(1) the board has adopted rules which set forth the procedures and
standards governing the grant or denial of a temporary variance;
and
(2) the board sets forth in writing the reasons for a grant or denial
of a temporary variance.
(d) The board shall adopt rules and procedures, in consultation with
the medical licensing board, concerning the electronic transmission of
prescriptions. The rules adopted under this subsection must address the
following:
(1) Privacy protection for the practitioner and the practitioner's
patient.
(2) Security of the electronic transmission.
(3) A process for approving electronic data intermediaries for the
electronic transmission of prescriptions.
(4) Use of a practitioner's United States Drug Enforcement
Agency registration number.
(5) Protection of the practitioner from identity theft or fraudulent
use of the practitioner's prescribing authority.
(e) The governor may direct the board to develop:
(1) a prescription drug program that includes the establishment of
criteria to eliminate or significantly reduce prescription fraud; and
(2) a standard format for an official tamper resistant prescription
drug form for prescriptions (as defined in IC 16-42-19-7(1)).
The board may adopt rules under IC 4-22-2 necessary to implement
this subsection.
(f) The standard format for a prescription drug form described in
subsection (e)(2) must include the following:
(1) A counterfeit protection bar code with human readable
representation of the data in the bar code.
(2) A thermochromic mark on the front and the back of the
prescription that:
(A) is at least one-fourth (1/4) of one (1) inch in height and
width; and
(B) changes from blue to clear when exposed to heat.
(g) The board may contract with a supplier to implement and
manage the prescription drug program described in subsection (e). The
supplier must:
(1) have been audited by a third party auditor using the SAS 70
audit or an equivalent audit for at least the three (3) previous
years; and
(2) be audited by a third party auditor using the SAS 70 audit or
an equivalent audit throughout the duration of the contract;
in order to be considered to implement and manage the program.
(h) The board shall adopt rules and procedures regarding a
pharmacist or pharmacy that violates IC 35-48-4-14.8.
milligrams.
(d) A person may not purchase drugs containing more than three
and six-tenths (3.6) grams of ephedrine or pseudoephedrine, or both,
on one (1) day, or more than nine (9) grams of ephedrine or
pseudoephedrine, or both, in a thirty (30) day period.
(e) This subsection only applies to convenience packages. A person
may not sell drugs containing more than one hundred twenty (120)
milligrams of ephedrine or pseudoephedrine, or both in any one (1)
transaction if the drugs are sold in convenience packages. A person
who sells convenience packages must secure the convenience packages
in at least one (1) of the following ways:
(1) The convenience package must be stored not more than thirty
(30) feet away from a checkout station or counter and must be in
the direct line of sight of an employee at the checkout station or
counter.
(2) The convenience package must be protected by a reliable
anti-theft device that uses package tags and detection alarms
designed to prevent theft.
(3) The convenience package must be stored in restricted access
shelving that permits a purchaser to remove not more than one (1)
package every fifteen (15) seconds.
(4) The convenience package must be stored in an area that is
under constant video monitoring, and a sign placed near the
convenience package must warn that the area is under constant
video monitoring.
(f) A retail distributor, wholesaler, or manufacturer shall report a
suspicious order to the state police department in writing.
(g) Not later than three (3) days after the discovery of an unusual
theft at a particular retail store, the retailer shall report the unusual theft
to the state police department in writing. If three (3) unusual thefts
occur in a thirty (30) day period at a particular retail store, the retailer
shall, for at least one hundred eighty (180) days after the date of the last
unusual theft, locate all drugs containing ephedrine or pseudoephedrine
at that particular retail store behind a counter in an area inaccessible to
a customer or in a locked display case that makes the drug unavailable
to customers without the assistance of an employee.
(h) A unit (as defined in IC 36-1-2-23) may not adopt an ordinance
after February 1, 2005, that is more stringent than this section.
(i) A person who knowingly or intentionally violates this section
commits a Class C misdemeanor. However, the offense is a Class A
misdemeanor if the person has a prior unrelated conviction under this
section.
or federal quantity limits relating to the sale or purchase of
ephedrine or pseudoephedrine. A person may not complete a
transaction if the PSE tracking system issues a stop sale alert for
the transaction.
(f) A person shall begin entering data into the PSE tracking
system not later than one hundred eighty (180) days after the
attorney general enters into a memorandum of understanding
described in section 14.9 of this chapter.