SB 285-1_ Filed 01/20/2010, 11:50
The Senate Committee on Corrections, Criminal, and Civil Matters, to which was referred Senate Bill
No. 285, has had the same under consideration and begs leave to report the same back to the Senate with
the recommendation that said bill be AMENDED as follows:
SOURCE: Page 1, line 1; (10)AM028506.1. -->
Page 1, between the enacting clause and line 1, begin a new
paragraph and insert:
SOURCE: IC 4-6-2-12; (10)AM028506.1. -->
"SECTION 1. IC 4-6-2-12 IS ADDED TO THE INDIANA CODE
AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2010]: Sec. 12. The attorney general shall enter into a
memorandum of understanding with an entity to implement an
electronic system to track the sale of ephedrine and
pseudoephedrine as required by IC 35-48-4-14.9.
SOURCE: IC 25-26-13-4; (10)AM028506.2. -->
SECTION 2. IC 25-26-13-4, AS AMENDED BY P.L.182-2009(ss),
SECTION 371, IS AMENDED TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2010]: Sec. 4. (a) The board may:
(1) promulgate rules and regulations under IC 4-22-2 for
implementing and enforcing this chapter;
(2) establish requirements and tests to determine the moral,
physical, intellectual, educational, scientific, technical, and
professional qualifications for applicants for pharmacists'
(3) refuse to issue, deny, suspend, or revoke a license or permit or
place on probation or fine any licensee or permittee under this
(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
(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
(9) perform such other duties and functions and exercise such
other powers as may be necessary to implement and enforce this
(b) The board shall adopt rules under IC 4-22-2 for the following:
(1) Establishing standards for the competent practice of
(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
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
(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;
(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
(1) Privacy protection for the practitioner and the practitioner's
(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
(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
(A) is at least one-fourth (1/4) of one (1) inch in height 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
(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
(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.
SOURCE: Page 5, line 24; (10)AM028506.5. -->
Page 5, line 24, delete "an" and insert " a statewide
Page 5, line 25, after "and" insert " pseudoephedrine.
Page 5, delete lines 26 through 27.
Page 6, line 2, delete "Except as provided in subsection".
Page 6, line 3, delete "(f), a" and insert " A
Page 6, delete lines 5 through 13, begin a new paragraph and insert:
" (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.
Page 6, line 16, delete "The state police".
Page 6, line 17, delete "department" and insert " The attorney
Page 6, delete line 18.
Page 6, line 19, delete "concerning implementation of" and insert
" an entity to implement
Page 6, line 21, delete "state police department" and insert
" attorney general
Page 6, line 21, delete "National" and insert " entity.
Page 6, delete line 22.
Page 6, line 23, delete "provide that:" and insert " provide:
(A) retailers; and
(B) law enforcement agencies;
may not be required to pay a fee for access to the system;
(2) that for investigative purposes, a law enforcement officer
shall have access to all information on the PSE tracking
(3) that sales transaction data will be housed by an
information technology company operating under strict
(4) that the data will be accessible only to authorized law
(5) that the entity will forward the data to the state police
(6) that the entity shall not modify sales transaction data that
is provided to law enforcement; and
(7) that the entity will ensure that the PSE tracking system
will have stop sale capability throughout the state as set forth
in section 14.8 of this chapter.".
Page 6, delete lines 24 through 35.
Renumber all SECTIONS consecutively.
(Reference is to SB 285 as introduced.)
and when so amended that said bill do pass .
Committee Vote: Yeas 8, Nays 2.
Senator Steele, Chairperson
AM 028506/DI 106 2010