Indiana Law

PART 1
Quick COVID-19 Disclaimer
As a result of the COVID-19 pandemic, the governor of
Indiana has declared a state of emergency, and has
loosened restrictions in a number of cases related to
pharmacy practice. Please note, for the purposes of this
class, we will not be considering any executive orders from
the governor.
Terminology
• A statute is “a written law enacted by the legislature”
o Federal law: listed in the US code
o Indiana law: listed in the Indiana Code
• A regulation is “a rule having the force of law issued by an
administrative agency”
o In pharmacy, federal rules or regulations are usually established by the
Food and Drug Administration and the Drug Enforcement Administration.
o Federal regulations: listed in the Code of Federal Regulations (CFR)
o State rules are established by state boards of pharmacy
o Indiana regulations: listed in the Indiana Administrative Code
 How to look up Indiana law
• Citations: how laws and regulations are cited as a reference to others
• Indiana law: IN Code http://iga.in.gov/legislative/laws/2019/ic/titles/001
Indiana code abbreviation, title number-article-chapter-section (subsection)
For example: IC 25-26-13-15
• IN regulations: Indiana Administrative Code http://www.in.gov/legislative/iac/iac_title?iact=856
Title number-Indiana Administrative Code abbreviation, article-chapter-section
(subsection)
For example: 856 IAC 1-3.1-11 (b) (1)
 Laws found in the Indiana Code
Title 25
Article 26
Written as IC 25-26-13-15
Chapter 13
Section 15
Rules found in the Indiana Administrative Code
Title 856
Article 1
Written as 856 IAC 1-3.1-11
Chapter (Rule) 3.1
Section 11
 Indiana Code Indiana Administrative Code*
Title Article Name Title Article Name
Regulation of Food, Drugs, Pharmacies and
16 42 856 1
and Cosmetics Pharmacists
General Provisions
25 1 856 2 Controlled Substances
(Licensing)

Pharmacists, Pharmacies, Automated Medication

25 26 856 5
Drug Stores Systems

Prescription Drug Take-

35 48 Controlled Substances 856 7
Back Programs
Practitioner defined
IC 25-1-9-2
As used in this chapter, "practitioner" means a person that holds:
(1) an unlimited license, certificate, registration, or permit;
(2) a limited or probationary license, certificate, registration, or permit;
(3) a temporary license, certificate, registration, or permit;
(4) an intern permit; or
(5) an inactive license;
issued by the board regulating a profession.
Practitioner defined
IC 16-42-19-5
As used in this chapter, "practitioner" means any of the following:
(1) A licensed physician.
(2) A veterinarian licensed to practice veterinary medicine in Indiana.
(3) A dentist licensed to practice dentistry in Indiana.
(4) A podiatrist licensed to practice podiatric medicine in Indiana.
(5) An optometrist who is:
◦ (A) licensed to practice optometry in Indiana; and
◦ (B) certified under IC 25-26-15.
(6) An advanced practice nurse who meets the requirements of IC 25-23-1-19.5.
(7) A physician assistant licensed under IC 25-27.5 who is delegated prescriptive authority under
IC 25-27.5-5-6.
Practitioner defined-for generic
substitution
IC 16-42-22-4.5
As used in this chapter, "practitioner" means any of the following:
(1) A licensed physician.
(2) A dentist licensed to practice dentistry in Indiana.
(3) A podiatrist licensed to practice podiatric medicine in Indiana.
(4) An optometrist who is:
(A) licensed to practice optometry in Indiana; and
(B) certified under IC 25-26-15.
(5) An advanced practice nurse licensed and granted the authority to
prescribe legend drugs under IC 25-23.
Prescribing authority
• Big Four: recognized in all states and jurisdictions
o Physicians (MD/DO)
o Dentists (DDS/DMD)
o Podiatrists (DPM)
o Veterinarians (DVM)
• Allowed to prescribe within their SCOPE of practice
• Even if licensed outside of IN you can fill their prescription
in IN as long as the prescription they write is valid based on
the laws of the state they are working in.
Prescribing authority
• Other prescribers: additional requirements are in place to
qualify for prescribing authority
o Nurse practitioners (MSN/DNP/APN)
o Physician assistants (PA)
o Optometrists (OD)
• Many states do NOT recognize prescribing authority of these
practitioners if they are licensed in another state or jurisdiction
• Indiana just passed a law (HB 1207) clarifying that prescriptions
written by NPs and PAs in other states should be honored in
Indiana
Mid-level practitioners
• Advanced Practice Nurses:
o Must work under a supervising practitioner (physician, dentist or podiatrist)
 Practitioner does not have to be physically present
o Can prescribe controlled substances if have a DEA number and IN controlled
substance registration
• Physician Assistants:
o Must work under a supervising physician
 Physician has to directly supervise or be personally available for assistance or via
electronic methods, or located within a reasonable travel distance
 Must have at least 1800 hours of practice before can prescribe controlled substances
• Optometrists:
o Practice independently
o Prescribe based on a formulary
o No controlled substances except tramadol
Prescriptions and Drug orders
• Prescription (IC 16-42-19-7) • Drug order (IC 16-42-19-3)
o Written order for outpatient o Written for inpatient use
o Must Contain: (hospital, long term care
 Name and address of patient facility, etc.)
 Name and strength/size of drug o Must contain:
 Amount to be dispensed o Name and bed number of the
patient
 Adequate directions for use o Name and strength/size of the drug
 Name of the practitioner o Amount to be dispensed
 Written or electronic signature of o Adequate directions for use
practitioner o Name of the prescriber
o Prescriber signature
 Prescription validity
• For a prescription or drug order to be valid, it has to be
issued:
1. For a legitimate medical purpose
2. By a practitioner acting in their usual course of practice

(IC 16-42-19-20)
 Exceptions to unlawful sale of legend
drugs
We, as pharmacists, can sell legend (i.e., prescription) drugs
ONLY if:
1. It is dispensed upon an original prescription or drug order
(or authorization of a practitioner) with the drug product
specified on the Rx/order
2. The label includes specific information (next slide)

(IC 16-42-19-11)
 Prescription labels
• Must contain:
o Name, address, and phone number of the dispensing pharmacy
o Date on which the prescription was filled
o The prescription number
o The name of the prescriber
o The name of the patient
 If it’s an animal, the name of the species
o The directions for use as provided in the prescription
o If the drug contains or is derived from opium, a statement that the drug is
an opioid
• Based on 856 IAC 1-23, it should also include:
o The name of the drug (brand or generic or both)
o For an animal, the owner’s name

(IC 16-42-19-11 and 856 IAC 1-23)

Practitioner dispensing
• If a practitioner dispenses from their office, the label must
include
o Directions for use
o Name and address of the practitioner
o Name of the patient
 If for an animal, information about the species
 Refills
• Prescriptions may not be refilled except under the following
circumstances:
1. As authorized under IC 25-26-13-25 (d). (next lecture!)
2. As designated on the prescription or drug order
3. By the authorization of the practitioner

(IC 16-42-19-12)
 Requirement of prescription for retail
sale of Insulin (IC 16-42-19-29)
• In Indiana, insulin can only be sold via a prescription
written:
• By a physician
• By a veterinarian
• By a nurse practitioner
• By a physician assistant
• SB 255 was just passed which will repeal this legislation
beginning January 1st, 2021

(IC 16-42-19-29)
Which types of insulin can
be sold without a
prescription in most
jurisdictions?
 Generic substitution
• The Orange Book (IC 16-42-22-4)
o Gives information on which pharmaceutical equivalents are
also therapeutic equivalents
• Veterinarians are NOT included in this chapter’s definition
of practitioners which means you can NOT substitute a
generic if a veterinarian wrote for a brand name (unless you
call first)

(IC 16-42-22)
 Generic substitution-Prescription form
Prescriptions must have two signature lines on the face
_________________ ________________
Dispense as Written May Substitute

• DAW must appear on left, MS on right

• Practitioner signs one to indicate what they want or
indicates with a statement on electronic prescription
• MUST inform the patient if we substitute
(IC 16-42-22-6, IC 16-42-22-8)
 Generic substitution-Rules and
exceptions
Medicaid/CHIP:
• For a prescription filled under the Medicaid program or the
children’s health insurance program or the Medicare program,
the pharmacist MUST substitute a generic drug AND inform the
patient of the substitution IF it results in a lower price
o Exceptions: The words Brand Medically Necessary (or similar)
are written on the prescription in their OWN handwriting (or
submitted electronically)
o If via a verbal authorization, prescriber must forward a written
or electronic prescription with the words Brand Medically
Necessary (or similar) on the prescription

(IC 16-42-22-10)
 Generic substitution-Dispensing
• If a pharmacist substitutes a generic drug for a brand name
drug, the prescription label MUST identify both products.
• The following language must be used on the label (i.e.,
prescription vial):
_________________ Generic for ______________
•The name of the manufacturer or distributor for the actual
product dispensed must be recorded on the prescription or
in an electronic format

(IC 16-42-22-11, IC 16-42-22-12)

 Biosimilar Substitution
• IC 16-42-25 Discusses products that are distributed by
pharmacists and do not specifically fall under the definition
of drug, including vaccines, serums, and blood products
• This language allows for equivalent biosimilar products to
be dispensed, but introduces a specific caveat:
• The pharmacist shall, not later than 10 days after dispensing,
notify the prescribing practitioner of the substitution.

(IC 16-42-25-4, IC 16-42-25-5)

 Overdose intervention drugs (i.e.,
naloxone)
• Pharmacists or pharmacies can dispense, based on a standing order, an overdose
intervention drug if:
o It is for a patient at risk of an opioid-related overdose or their family member or friend who are in a
position to assist
o You have to instruct the individual receiving the drug to summon emergency services immediately
before or after administering the drug
o Educate on administration of the overdose intervention drug
o Provide drug addiction treatment information and referral to drug treatment programs
• Immunity:
(c) Except for an act of gross negligence or willful misconduct, an individual or entity
described in section 2(a)(1) of this chapter is immune from civil liability for the following
actions:
(1) Obtaining an overdose intervention drug under this chapter.
(2) Administering an overdose intervention drug in good faith.
(3) Acting under a standing order under this chapter.

(IC 16-42-27-2, IC 16-42-27-3)

 Actions for which a practitioner can be
sanctioned (not the full list)
• Engaging in fraud or deception to obtain a license to practice, engaging in fraud in the course of professional services, falsely
advertising services, or being convicted of a crime or assessed a civil penalty due to fraudulent billing practices.
• Being convicted of a crime that has a direct bearing on a practitioner’s ability to practice competently or is harmful to the
public.
• Knowingly violating any federal or state laws and rules regulating a practitioner’s profession.
• Practicing although a practitioner is unfit to practice due to professional incompetence, lack of knowledge about current theory
or practice, physical or mental disability, and addiction, abuse, or dependency on alcohol or other drugs.
• Allowing a practitioner’s name or license to be used by someone to render services beyond the scope of the individual’s
training, experience, or competence.
• Having disciplinary action taken against the practitioner in another state or jurisdiction. Per IC 25-1-9-4(c), a certified copy of
the disciplinary action is conclusive evidence of another jurisdiction’s actions.
• Diverting a drug or other device.
• Knowingly prescribed, sold, or administered a narcotic, addicting, or dangerous drug to an addict.
• Not complying with an order imposing a sanction.
• If the practitioner is participating in a health maintenance organization (HMO), knowingly collecting or attempting to collect a
payment from a patient that should be paid by the HMO.

(IC 25-1-9-4)
Main goal of the state and the board of
pharmacy is protecting the public and
enforcing the laws and rules that govern
pharmacy.
 Board Mandated Physical/Mental Exam
• The board may require a physical or mental examination to
determine if a practitioner is capable to practice. This
requirement must stem from a disciplinary hearing.

IC 25-1-9-7
 Disciplinary Sanctions
• State’s responsibility to show a practitioner has done
something requiring a sanction
o Will typically have a hearing (usually means the state board of
pharmacy will have evidence against the practitioner)
o Practitioner is allowed to have legal representation
o If a sanction is imposed, the practitioner is allowed to appeal to a
court of law.
o Appeal looks at if board followed appropriate procedures and
followed the law (not at the case facts)
Sanctions (can be individual or in
combination)
• Revocation: license taken away permanently
• Suspension: cannot practice
• Probation: can practice but with limits or additional requirements
• Letter of reprimand: written expression of disapproval (what the practitioner did
wrong)
• Censure: verbal expression of disapproval
• Fine: up to $1000 for each violation (except incompetence due to physical or mental
disability)

(IC 25-1-9-9)
 Suspension, Revocation, and Surrender
• Suspension
o Can NOT practice
o Typically suspended indefinitely and board can set a minimum amount of time before you
can apply for reinstatement
• Reinstatement may include additional disciplinary or corrective measures or probation
• Revocation
o License taken away PERMANENTLY, which means you can NOT practice
o Can NOT be reinstated
o Can apply for a NEW license (with a new license number) after seven years from the date of revocation
(take all the licensing exams again). Board may or may not allow it.
• Surrender (NOT a sanction)
• Practitioner petitions the board to surrender their license INSTEAD of a hearing (Board may or may not
agree to accept)
• Board may impose additional conditions on the surrender (such as lifetime prohibition against
reinstatement or issue of a new license)

(IC 25-1-9-11, IC 25-1-9-12, IC 25-1-9-14)

 Refusal of Licensure
• Refusal of licensure can occur if:
•The applicant has been disciplined or could be disciplined
by another state or jurisdiction; and
•The violation the applicant may have been disciplined for
has a direct bearing on the applicant’s ability to practice in
Indiana.
•Anyone who has practiced without a license may also be
refused a license

(IC 25-1-9-16)
 Probationary Licensure
• The board may issue a probationary license and impose
one or more of the following conditions:
1. Report regularly to the board on the matters requiring a probationary
license
2. Limit practice to those areas prescribed by the board
3. Continue or renew professional education
4. Engage in community service as directed by the board
5. Perform, or refrain from performing, an act that the board considers
appropriate to public interest

IC 25-1-9-16
IN Board of Pharmacy
• Meetings: https://www.in.gov/pla/2544.htm
• Minutes: https://www.in.gov/pla/2543.htm
• Decisions: https://www.in.gov/ai/appfiles/pla-litigation/
Part 1

• Thoughts about the case

• Do you agree with the
Board’s decision?
Part 2

• Thoughts?
• Do you agree with the
Board’s decision?
Questions?