Indiana Pharmacy law Review 2020©

Pharmacy Education Source, PLLC
Peter P. Cohron, BSPharm, JD
petercohron@gmail.comPharmacyEducationSource@gmail.com
Cell: 859-227-9089

This law review handout is based on the “black letter law,” the law necessary for you to pass the
board examination. It does not entertain various scenarios from the “real world” nor discuss anything
other than the “black letter law.” From experience and discussions with others on this issue, the following
are the topics considered to be the most important and seen most often on the Indiana multi-state board
jurisprudence exam. This is NOT a complete review of Indiana pharmacy law.
Some headings have been provided but that is no guarantee that everything regarding that title is
under it. Federal and state citations are added solely for my edification (so I know where to go to check
for updates/changes as time goes by); there has never, to my knowledge, been a question on the pharmacy
law exam requiring a citation to a specific regulation or statute.
The information on this handout reflects what will be on the law exam. Some recent changes in
the law that should not be on the exam are covered and there is a NOTE about that. You are not
examined on recent changes—they must be in effect for one year prior to their being on the MPJE.
This year’s Review (2019) has been modified as best as possible to reflect this year’s changes in
the MPJE.
Disclaimer: This review is a “distillation” of pharmacy law; it is not exact; certain parts of the law I
consider unnecessary have been reworded or omitted. I cannot say that one day the Board will not get
more exact and include something I deliberately left out. This is a review for a board examination and
should only be used for that purpose. It should not be used or relied on as a substitute for a true copy of
the state and federal laws governing the practice of pharmacy. It is not a true copy of the Indiana
Pharmacy Practice Act or the Controlled Substance Act. Keep in mind that the law changes; I have made
every effort to be up to date but do not guarantee that recent changes in the law are included.
COPYRIGHT, June 2020 by Peter P. Cohron, BSPharm, JD. Any unauthorized sharing, exhibition, use
or copying of this material subjects the person doing so to appropriate legal action.
Petr P. Cohron, BSPharm, JD, is a 1980 graduate of the University of Kentucky College of Pharmacy and
a 1993 graduate of the UK College of Law. He taught pharmacy and health law at UK for 10 years from
2002 to 2011. Currently, he is the owner and operator of Pharmacy Law Source and a partner in
Pharmacy Education Source, two businesses that provide legal counsel and advice to pharmacists, interns,
technicians and pharmacies nationwide, as well as educational materials. Peter has been doing MPJE
preps for several states since 1998 and enjoys a first attempt pass rate for those using his materials of
better than 98%. Licensed in Indiana, Kentucky, and Tennessee, he is currently a member of the
Kentucky Board of Pharmacy.

Board of Pharmacy

Ind Code 25-26-13-3(a)(2013) Board of Pharmacy
–consists of 7 members
–no more than 4 of the same political party
–one consumer member, must be Indiana resident and no affiliation with pharmacy
–one member must be a practicing hospital pharmacist; others must be from varied practice settings
–appointed by the governor
–term of office is four years

Ind Code 25-26-13-3(b)(2013) Qualifications: for Board Members
–licensed in Indiana
–in good standing with the Board
–recognized experience and ability

Ind Code 25-26-13-3(c)-(e)(2013) Meetings
–must meet at least eight times a year
–four members constitutes a quorum
–meetings may continue up to no more than 5 days
–elects a president and vice-president at first meeting each year

Executive Director—the Board shall hire an executive director to run the board office and other such
employees as are deemed necessary

Board inspectors or “enforcement officers”
–may conduct inspections
–seize evidence
–make arrests
–serve warrants, subpoenas, etc

Board duties
–regulate the profession
–regulate the sale of drugs and medical devices
–license certain individuals
–establish standards of practice
–establish minimum standards for pharmacies
–investigate complaints

Board may suspend, revoke, or limit a license, levy fines

Pharmacists

Ind Code 25-26-13-11(2013) and 25-26-13-14(2013) Pharmacist Qualifications and License
–at least 18 years old
–not been convicted of a crime that would bear on the ability to competently practice
–graduated from a Board approved college of pharmacy, also accredited by Accreditation Council for
Pharmacy Education, or graduated from a foreign CoP & met the requirements for one educated outside
the US/Canada (obtained a Foreign Pharmacy Graduate Examination Committee Certificate
–met the requirements of internship/externship
–passing the NAPLEX and MPJE with an score of 75%
–shall be prominently displayed

A qualifying pharmacist is the “PIC” and is responsible for the operation, safety, security, etc of the
pharmacy

Licensure
–license is good for two years—expires on June 30 of even numbered years
–renewal must be accompanied by statement affirming that required CE was obtained

856 IAC -35-7 Pharmacist license (pharmacist who work primarily there, not floaters) and pharmacy
permit shall be displayed where the public can see them

Ind Code 25-1-8-6(c)-(d)(2013 License expired for less than 3 years, Board may reinstate if pharmacist
–completes required CE
–applies in writing for reinstatement
–pays renewal and reinstatement fee

Ind Code 25-1-8-6(c)-(d)(2013) License expired for more than 3 years, Board may reinstate if pharmacist
–completes required CE
–applies in writing for reinstatement
–pays renewal and reinstatement fee
–completes additional training deemed appropriate by the Board
–completes other requirements that may exist

Ind Code 25-26-13-13(2013) Inactive License
–must pay fees but is exempt from CE
–may not practice pharmacy

Ind Code 25-26-13-12(2013) Reciprocal License
–license requirements at original time of issue must equal Indiana’s
–pharmacist has registered with & been approved by National Association of Boards of Pharmacy
–graduated from a Board approved college of pharmacy, also accredited by Accreditation Council for
Pharmacy Education
–passed the Indiana MPJE
–may be required to have a personal interview before the Board
–NAPLEX may be required if the pharmacist has not been in practice the preceding 12 months

856 IAC 1-26-1 Continuing education
–30 hours of CE every two years
–no carryover into next biennium
–must be approved by either ACPE or the Board
–time period for CE is Jan 1 of even-numbered years through Dec 31 of odd-numbered years
–maximum of one-fifth may be business, management or computer related

Ind Code 25-26-13-2(2013) Practice of Pharmacy
–providing interpretation, evaluation, and implementation of prescription orders
–compounding, labeling, administering, dispensing, selling of drugs & devices whether from a prescriber
–safety, storage and distribution of drugs & devices
–proper recordkeeping
–counseling, advising, and educating patients
–assessing and reporting events related to drugs & devices
–proper use of professional judgment—in the best interests of the patient

Pharmacist Protocols 16-19-4-11
–currently only smoking cessation
–pharmacist must be IND licensed
–pharmacist must be educated/trained in tobacco use disorder
–pharmacist must include tobacco cessation in CE every biennium
–limited to certain drugs
Bupropion SR Chantix Nicotine lozenges, gum patches, inhaler, nasal spray
–must do assessment of patient and council patient
–must inform patient’s PCP

Ind Code 25-26-13-2(2013) Pharmacy Intern
–must be under the personal supervision of a pharmacist & is satisfactorily progressing toward meeting
licensure requirements
–graduate of an approved college of pharmacy
–awaiting licensure examination
–participating in a residency or fellowship program

Ind Code 25-26-13-10 Intern Qualifications
–actively enrolled in a college of pharmacy
–paid the required fee

Ind Code 25-26-13-10(b)(2013) Intern License
–good for one year—may be renewed
–if CoP is accredited, 4th year experiential education suffices
–if not accredited 1500 hours—written description to the Board

Pharmacy technicians
–works under the direct supervision of a pharmacist
–performs duties that do not require a pharmacist’s professional judgment
–included in this category are cashiers, clerks, secretaries, delivery people but not interns

Pharmacist-tech ratio: one pharmacist to six techs
–must be under “immediate and personal supervision” or reasonable visual and vocal distance
856 IAC 1-35-7 ID Badge—techs shall wear identification which identifies tech as a tech
–tech shall identify herself as a tech when engaged in telephone or electronic communications
Qualifications
–cannot have been convicted of any crime that would bear on ability to be a tech
–high school graduate, GED, or have been judged competent by qualifying pharmacist
–successfully completed approved training program within 12 months of hire or successfully completed
Board approved certification exam
Training records—
–Pharmacist who qualifies pharmacy permit must keep readily retrievable of tech training
–record shall include
–tech name
–date of hire
–date started & date completed tech training program
–copy of the training manual
Activities
–pharmacist assumes responsibility for tech’s work under her supervision
–drug order or prescription preparation
–may take prescription refill OK or denial, no new Rxs
–may NOT
–assume any duty belonging to the pharmacist
–provide advice or consult with prescriber
–provide advice or consult with the patient
–provide drug information to patients
–do the final check or verification
Pharmacist: tech/intern ratio 25-26-13-1.5
–1:6 pharmacist to techs (includes in training techs) and interns
–no more than 3 of the 6 maybe techs in training
–tech at a remote dispensing site counts in this ratio
ICA 25-26-13-4.5(2013) Impaired Pharmacist
–defined as a pharmacist affected by abuse of drugs or alcohol
–the Board shall assist in the rehabilitation of the pharmacist
–may enter into agreements, provide grants or make suitable arrangements with entities
specializing in the rehab of health care professionals
–all info provided to these entities is privileged and confidential
–if told that the pharmacist is non-compliant, the Board may use this information in proceedings
against the pharmacist’s license
856 IAC 1-33-1 Prescription Counseling
–appropriate communication from pharmacist to patient to improve therapeutic outcomes
–offer to counsel is required
–offer must be made on new and refill prescriptions
–if accepted counseling must be in person or telephonic
–counseling must be given to patient, caregiver or patient’s representative
–counseling not required if patient “knowingly” declines—record of refusal must be kept for TWO years
–counseling NOT required for patients in institutional setting
Patient Records and Patient Counseling
A/K/A OBRA 90
Patient records
A pharmacist or designee shall obtain pertinent patient information which shall be readily retrievable and
show the pharmacist previously dispensed drugs and known disease states, shall also require the
pharmacist to perform a prospective DUR with the newly dispensed drug. Information in the record shall
include:
patient’s full name address & telephone number age or date of birth
gender list of all Rxs obtained in the previous 12 months known disease states
drug allergies
Patient records are confidential; this does not include counseling
856 IAC 1-20-1 ICA 25-26-13-29(2013) Prohibited Acts
–sell or dispense adulterated or misbranded drugs
–sell or dispense counterfeit drugs
–dispense from a forged Rx
–practice in an incompetent manner
–aid or abet an unlicensed person to practice
–violate applicable law
Ind Code 25-1-9-4 Standards of Practice
–fraud, misrepresentation, convicted of a crime, continuing to practice when impaired, sexual
misconduct, knowingly violated a law that governs practice: ALL of these open the pharmacist to
discipline
Immunizations
–must be trained
–flu, pneumonia, tDap, HPV, meningitis or shingles under a prescription or protocol drug order
–intern may administer under direct supervision by another health care professional
–pharmacy must inform prescriber within 14 days—prescriber must be in active practice and not
employed by a pharmacy
–may immunize down to 11 years of age
–for pneumonia, patient must be 50
–written consent required
–name, license # & contact info for protocol doctor must be displayed & available for inspection