Bill Text: IN SB0285 | 2010 | Regular Session | Amended
Bill Title: Sale and tracking of ephedrine.
Spectrum: Slight Partisan Bill (Republican 2-1)
Status: (Engrossed - Dead) 2010-02-08 - First reading: referred to Committee on Public Policy [SB0285 Detail]
Download: Indiana-2010-SB0285-Amended.html
Citations Affected: IC 4-6; IC 25-26; IC 35-48.
Synopsis: Sale and tracking of 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. Prohibits a retailer from selling, and a purchaser from
purchasing, more than 3.6 grams of ephedrine or pseudoephedrine on
one day, or nine grams of ephedrine or pseudoephedrine in a 30 day
period. Requires a retailer to electronically transmit certain information
concerning the sale of ephedrine and PSE to a statewide PSE tracking
system. Specifies that the board of pharmacy shall 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 a memorandum of understanding.
Effective: July 1, 2010; January 1, 2011.
January 11, 2010, read first time and referred to Committee on Corrections, Criminal, and
Civil Matters.
January 21, 2010, amended, reported favorably _ Do Pass.
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A BILL FOR AN ACT to amend the Indiana Code concerning
criminal law and procedure.
(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' licenses;
(3) refuse to issue, deny, suspend, or revoke a license or permit or place on probation or fine any licensee or permittee under this
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.
(1) Ephedrine or pseudoephedrine dispensed pursuant to a prescription.
(2) The sale of a drug containing ephedrine or pseudoephedrine to a licensed health care provider, pharmacist, retail distributor, wholesaler, manufacturer, or an agent of any of these persons if the sale occurs in the regular course of lawful business activities. However, a retail distributor, wholesaler, or manufacturer is required to report a suspicious order to the state police department in accordance with subsection (f).
(3) The sale of a drug containing ephedrine or pseudoephedrine by a person who does not sell exclusively to walk-in customers for the personal use of the walk-in customers. However, if the person described in this subdivision is a retail distributor, wholesaler, or manufacturer, the person is required to report a suspicious order to the state police department in accordance with subsection (f).
(b) The following definitions apply throughout this section:
(1) "Constant video monitoring" means the surveillance by an automated camera that:
(A) records at least one (1) photograph or digital image every ten (10) seconds;
(B) retains a photograph or digital image for at least seventy-two (72) hours;
(C) has sufficient resolution and magnification to permit the identification of a person in the area under surveillance; and
(D) stores a recorded photograph or digital image at a location
that is immediately accessible to a law enforcement officer.
(2) "Convenience package" means a package that contains a drug
having as an active ingredient not more than one hundred twenty
(120) milligrams of ephedrine or pseudoephedrine, or both.
(3) "Ephedrine" means pure or adulterated ephedrine.
(4) "Pseudoephedrine" means pure or adulterated
pseudoephedrine.
(5) "Suspicious order" means a sale or transfer of a drug
containing ephedrine or pseudoephedrine if the sale or transfer:
(A) is a sale or transfer that the retail distributor, wholesaler,
or manufacturer is required to report to the United States Drug
Enforcement Administration;
(B) appears suspicious to the retail distributor, wholesaler, or
manufacturer in light of the recommendations contained in
Appendix A of the report to the United States attorney general
by the suspicious orders task force under the federal
Comprehensive Methamphetamine Control Act of 1996; or
(C) is for cash or a money order in a total amount of at least
two hundred dollars ($200).
(6) "Unusual theft" means the theft or unexplained disappearance
from a particular retail store of drugs containing ten (10) grams or
more of ephedrine, pseudoephedrine, or both in a twenty-four (24)
hour period.
(c) This subsection does not apply to a convenience package. A
person may sell a drug that contains the active ingredient of ephedrine,
pseudoephedrine, or both only if the person complies with the
following conditions:
(1) The person does not sell the drug to a person less than
eighteen (18) years of age.
(2) The person does not sell drugs containing more than three (3)
and six-tenths (3.6) grams of ephedrine or pseudoephedrine, or
both, in one (1) transaction. to one (1) individual on one (1) day,
or nine (9) grams of ephedrine or pseudoephedrine, or both,
to one (1) individual in a thirty (30) day period.
(3) The person requires:
(A) the purchaser to produce a state or federal identification
card;
(B) the purchaser to complete a paper or an electronic log in
a format approved by the state police department with the
purchaser's name, address, and driver's license or other
identification number; and
(C) the clerk who is conducting the transaction to initial or
electronically record the clerk's identification on the log; and
(D) the clerk who is conducting the transaction to
electronically transmit information relating to the sale of
ephedrine or pseudoephedrine to the PSE tracking system
in accordance with section 14.8 of this chapter.
Records from the completion of a log must be retained for at least
two (2) years. A law enforcement officer has the right to inspect
and copy a log or the records from the completion of a log in
accordance with state and federal law. A person may not sell or
release a log or the records from the completion of a log for a
commercial purpose. The Indiana criminal justice institute may
obtain information concerning a log or the records from the
completion of a log from a law enforcement officer if the
information may not be used to identify a specific individual and
is used only for statistical purposes. A retailer who in good faith
releases information maintained under this subsection is immune
from civil liability unless the release constitutes gross negligence
or intentional, wanton, or willful misconduct. This subdivision
expires June 30, 2012.
(4) The person stores the drug:
(A) behind a counter in an area inaccessible to a customer or
in a locked display case that makes the drug unavailable to a
customer without the assistance of an employee; or
(B) directly in front of the pharmacy counter in the direct line
of sight of an employee at the pharmacy counter, in an area
under constant video monitoring, if the drug is sold in a retail
establishment that:
(i) is a pharmacy; or
(ii) contains a pharmacy that is open for business.
(d) A person may not purchase drugs containing more than three (3)
and six-tenths (3.6) grams of ephedrine or pseudoephedrine, or both,
in on one (1) week. 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 under section 14.8 of this chapter.
(j) Before June 30, 2007, the state police department shall submit a
report to the legislative council detailing the effectiveness of this
section in reducing the illicit production of methamphetamine. The
report must describe the number of arrests or convictions that are
attributable to the identification and logging requirements contained in
this section, and must include recommendations for future action. The
report must be in an electronic format under IC 5-14-6.
(1) Ephedrine or pseudoephedrine dispensed under a prescription.
(2) The sale of a drug containing ephedrine or
pseudoephedrine to a licensed health care provider,
pharmacist, retail distributor, wholesaler, manufacturer, or
an agent of any of these persons if the sale occurs in the
regular course of lawful business activities. However, a retail
distributor, wholesaler, or manufacturer shall report a
suspicious order to the state police department under section
14.7(f) of this chapter.
(3) The sale of a drug containing ephedrine or
pseudoephedrine by a person who does not sell exclusively to
walk-in customers for the personal use of the walk-in
customers.
(b) As used in this section, "PSE tracking system" means a
statewide electronic system to track the sale of ephedrine and
pseudoephedrine.
(c) As used in this section, "stop sale alert" means a notification
from the PSE tracking system that the completion of a sale would
result in the purchaser violating state or federal quantity limits
relating to the sale or purchase of ephedrine or pseudoephedrine.
(d) A person who sells ephedrine or pseudoephedrine shall enter
the following information into the PSE tracking system before
completing the sale:
(1) The name of the purchaser.
(2) The address of the purchaser.
(3) The name of the product containing ephedrine or
pseudoephedrine that is being purchased.
(4) The amount of the product containing ephedrine or
pseudoephedrine that is being purchased.
(e) The PSE tracking system must issue a stop sale alert if the
completion of a sale would result in the purchaser violating state
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.
(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.
attorney general and the entity.
(b) The memorandum of understanding must provide:
(1) that:
(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
system;
(3) that sales transaction data will be housed by an
information technology company operating under strict
security standards;
(4) that the data will be accessible only to authorized law
enforcement officers;
(5) that the entity will forward the data to the state police
department weekly;
(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.