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Pharmacy Resources

Controlled Substance Prescriptions

  • Controlled Substance Prescriptions

    A prescription for a controlled substance may be issued by one of the following practitioners licensed in Indiana:

    1. physician,
    2. osteopathic physician,
    3. veterinarian,
    4. dentist,
    5. podiatrist,
    6. advanced practice nurse who meets the requirements of IC 25-23-1-19.5, or
    7. a physician assistant licensed under IC 25-27.5 and is delegated prescriptive authority under IC 25-27.5-5-6.

    The practitioner must hold an Indiana Controlled Substance Registration ("CSR") and a federal Drug Enforcement Agency ("DEA") registration or is exempted from registration pursuant to 856 IAC 2-3-5(b) or 856 IAC 2-3-6 in order to prescribe a controlled substance.

    Controlled substance prescriptions issued by a physician, podiatrist, dentist, physician assistant, advance practice nurse practitioner, or veterinarian licensed under the laws of another state are considered valid prescriptions if the practitioner has a current and valid DEA registration and that the prescription has been issued in compliance with the laws of the originating state.  It is the pharmacist's responsibility, as with all controlled substances prescriptions, to be sure beyond reasonable doubt that the practitioner is issuing the prescription in good faith and has a valid DEA registration.

  • Prescription Pad Requirements

    All controlled substance prescriptions written by Indiana licensed practitioners [as defined by IC 16-42-19-5] must comply with DEA requirements as well as with 856 IAC 1-34 and IC 16-42-22-6 in order for their prescriptions to be accepted for filling in Indiana licensed pharmacies.

    Indiana licensed practitioners must use controlled substance prescription blanks (security feature prescription paper) from an approved vendor:

    Security Feature Prescription Paper    All controlled substance prescriptions written by licensed Indiana practitioners must contain the following security features:

    1. A latent, repetitive "void" pattern in reflex blue must appear across the entire face of the document when the prescription is photocopied;
    2. A watermark reading "Indiana Security Prescription" must be printed on the back of the paper; these words must appear at a 45 degree angle, horizontally in a step-and-repeated pattern in 5 lines, using 12-point Helvetica bold type style;
    3. An opaque RX symbol must appear in the upper right-hand corner corner, 1/8 of an inch from the top and 5/16 of an inch from the right side.  This symbol must be 3/4 of an inch and disappear if the prescription copy is lightened;
    4. Six (6) quantity check-off boxes and the following quantities must be printed on the form and the appropriate box checked off:  "1-24", "25-49", "50-74", "75-100", "101-150", and "151 and over";
    5. No advertisements may appear on the front or back;
    6. Logos may appear in the upper left one-inch square;
    7. Only one prescription may be written per blank.  The following statement must be printed on the bottom of the pad:  "Prescription is void if more than one (1) prescription is written per blank.";
    8. Refill options that can be circled must appear below any logos and above the signature lines on the left side of the prescription in the following order:  "Refill NR 1 2 3 4 5 Void after _____"
    9. Practitioner full name, address, DEA number, and state issued license number must be preprinted, stamped, or manually printed on the prescription;
    10. All prescription blanks must be 4 1/4 inches high and 5 1/2 inches wide;
    11. Two signature lines printed at the bottom of the form:  under the blank line on the left side must be printed the words "Dispense as Written", under the blank line on the right side must be printed the words "May Substitute".
    12. The name of any controlled substance may not be preprinted on any prescription forms at any time prior to the prescription being prepared and executed for presentation to the patient or the patient's agent.  That includes, but is not limited to, typing prescriptions in anticipation of their need and/or using a rubber stamp or similar means to accomplish the same end.  Commercially printed forms containing names of controlled substances are also prohibited.

    Template of Indiana Security Features for Prescriptions

    If you have any questions, please email the Indiana Board of Pharmacy at pla4@pla.IN.gov.

  • Facsimile (Fax) Prescriptions

    Rule 31. Facsimile Machines

    856 IAC 1-31-1 "Facsimile machine" definedAuthority: IC 25-26-13-4Affected: IC 25-26-13-2

    Sec. 1. As used in this rule, "facsimile machine" means a machine that electronically transmits exact images through connection with a telecommunications network. (Indiana Board of Pharmacy; 856 IAC 1-31-1; filed Mar 31, 1992, 5:00 p.m.: 15 IR 1390; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA)

    856 IAC 1-31-2 Use of a facsimile machine to electronically transmit a prescription or drug orderAuthority: IC 25-26-13-4Affected: IC 25-1-9; IC 25-26-13-15

    Sec. 2. Prescription or drug orders for legend drugs, including schedules II through V substances, may be transmitted by facsimile machine from an authorized prescribing practitioner or an authorized employee or agent of the inpidual practitioner to a pharmacy under the following restrictions:

    (1) A prescription or drug order for a schedule II controlled substance may be transmitted to a pharmacy via facsimile equipment, provided the original written, signed prescription or drug order is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in subpision (2) or (3).

    (2) A prescription or drug order prepared in accordance with 856 IAC 2-6-4 written for a schedule II narcotic substance to be compounded for the direct administration to a patient in a private residence, long-term care facility, or hospice setting by means of:

    (A) parenteral;

    (B) intravenous;

    (C) intramuscular;

    (D) subcutaneous; or

    (E) intraspinal;

    infusion may be transmitted by facsimile.

    (3) A prescription or drug order prepared in accordance with 856 IAC 2-6-4 written for a schedule II substance for a resident of a long-term care facility licensed under 410 IAC 16.2-3.1 may be transmitted to the dispensing pharmacy by facsimile.

    (4) A prescription or drug order prepared in accordance with 856 IAC 2-6-4 written for a schedule II narcotic substance for a patient enrolled in a hospice program, inpatient or outpatient, certified by Medicare under Title XVIII or licensed by Indiana may be transmitted to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription or drug order that the patient is a hospice patient.

    (5) The receiving facsimile machine must be located in the nonpublic area of the licensed pharmacy to protect patient/pharmacist/authorizing prescribing practitioner confidentiality and security as required by IC 25-26-13-15.

    (6) Using facsimile equipment to circumvent documentation, authenticity, verification, or other standards of the profession of pharmacy as defined by IC 25-26-13 or this title will be considered professional incompetence under IC 25-1-9.

    (Indiana Board of Pharmacy; 856 IAC 1-31-2; filed Mar 31, 1992, 5:00 p.m.: 15 IR 1390; filed Aug 17, 1995, 8:30 a.m.: 19 IR 39; filed May 26, 2000, 8:52 a.m.: 23 IR 2502; filed May 10, 2001, 9:22 a.m.: 24 IR 3067; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA)

    856 IAC 1-31-3 Facsimile prescription or drug order maintenance

    Authority: IC 25-26-13-4

    Affected: IC 25-1-9; IC 25-26-13-25

    Sec. 3. The facsimile serves as the original written prescription or drug order, and it shall be maintained in accordance with IC 25-26-13-25. (Indiana Board of Pharmacy; 856 IAC 1-31-3; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA)

  • Controlled Substance Prescription Requirements

    A prescription for a controlled substance must be issued for a legitimate medical purpose in a reasonable quantity by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing is upon the prescribing practitioner.

    All prescriptions for controlled substances shall be written with ink, indelible pencil, or typewriter, and shall be issued with the following:

    1. dated as of and signed on the day when issued;
    2. full name and address of patient;
    3. name, address, and DEA registration number of the practitioner;
    4. manual signature of prescriber;
    5. name, strength, dosage, quantity of the drug being prescribed;
    6. directions for use;
    7. number of refills (if any);

    The prescribing practitioner is responsible for ensuring that the prescription conforms to all requirements of both state and federal regulations.

    All controlled substance prescriptions written by Indiana licensed practitioners [as defined by IC 16-42-19-5] must be issued on approved security feature prescription pad paper [856 IAC 1-34] in order for their prescriptions to be accepted for filling in Indiana licensed pharmacies. A listing of approved vendors may be found on the Board of Pharmacy's website at http://www.bop.in.gov/.

    The name of any controlled substance may not be preprinted on any prescription forms at any time prior to the prescription being prepared and executed for presentation to the patient or the patient's agent.  That includes, but is not limited to, typing prescriptions in anticipation of their need and/or using a rubber stamp or similar means to accomplish the same end.  Commercially printed forms containing names of controlled substances are also prohibited.

    While some states and insurance carriers limit the quantity of controlled substances dispensed to a 30-day supply, there are no specific federal limits to quantities of drugs dispensed via a prescription.  Indiana law does not address quantities, therefore we require you to defer to federal guidelines.

    Indiana law requires that a prescription for a schedule II prescription must be filled within one (1) year of being signed.  Schedule III, IV, and V controlled substances shall be filled or refilled no more than six (6) months after the date on which such prescription was issued, and no prescription shall be authorized to be refilled more than five (5) times.

    If you have any questions, you may contact the Committee office at pla4@pla.IN.gov.

  • Issuance of Multiple Prescriptions

    The refilling of a prescription for a controlled substance listed in schedule II is prohibited.

    The DEA has revised its regulations regarding the issuance of multiple prescriptions for schedule II controlled substances.  A prescribing practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the following conditions are met:

    1. Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
    2. The individual practitioner provides written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription;
    3. The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
    4. The issuance of multiple prescriptions is permissible under state laws (Indiana law defers to federal regulations regarding this issue);
    5. The individual practitioner complies fully with all other applicable requirements under the CSA and CFR as well as Indiana law.
  • Authorization for Emergency Dispensing

    An emergency situation means those situations that:

    1. immediate administration of the controlled substance listed in schedule II is necessary;
    2. no appropriate alternative treatment is available; and
    3. it is not reasonably possible for the prescriber to provide a written prescription.

    In case of an emergency situation, a pharmacist may dispense a controlled substance listed as a schedule II upon receiving oral authorization of a prescribing practitioner, provided the following:

    1. the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period only;
    2. the prescription shall be immediately reduced to writing by the pharmacist;
    3. if the prescribing individual practitioner is not known to the pharmacist, s/he must make reasonable effort to determine that the oral authorization came from a registered individual practitioner; and
    4. within seven (7) days after authorizing he emergency oral prescription, the prescriber shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist.  The prescription shall have "Authorization for Emergency Dispensing" written on it face and the date of the oral order.  The written prescription may be delivered to the pharmacist in person or by mail; if by mail, it must be postmarked within the seven (7) day period.  The pharmacist shall notify the Board of Pharmacy if the prescriber fails to deliver the written prescription.
  • Prescriptions for Weight Reduction

    Indiana Code 35-48-3-11 states that only a physician licensed under IC 25-22.5, a physician assistant licensed under IC 25-27.5, or an advanced practice nurse licensed under IC 25-23 with prescriptive authority may treat a patient with a Schedule III or Schedule IV controlled substance for the purpose of weight reduction or to control obesity.

    A physician licensed under IC 25-22.5, a physician assistant licensed under IC 25-27.5, or an advanced practice nurse licensed under IC 25-23 with prescriptive authority may not prescribe, dispense, administer, supply, sell, or give any amphetamine, sympathomimetic amine drug, or compound designated as a Schedule III or Schedule IV controlled substance under IC 35-48-2-8 and IC 35-48-2-10 for a patient for purposes of weight reduction or to control obesity, unless the physician, physician assistant, or advanced practice nurse does the following:

    1. Determines through review of the physician's records of prior treatment of the patient or the records of prior treatment of the patient provided by a previous treating physician or weight loss program, that the physician's patient has made a reasonable effort to lose weight in a treatment program using a regimen of weight reduction based on caloric restriction, nutritional counseling, behavior modification, and exercise without using controlled substances and that the previous treatment has been ineffective for the physician's patient.
    2. Obtains a thorough history and performs a thorough physical examination of the physician's patient before initiating a treatment plan using a Schedule III or Schedule IV controlled substance for purposes of weight reduction or to control obesity.
  • Theft of Loss of Controlled Substances

    Every DEA registrant is required to notify the DEA field office in their area of any theft or significant loss of controlled substances upon its discovery.  Every DEA registrant (practitioner, pharmacy, hospital/clinic, manufacturer, distributor, etc.) must comply with this requirement.  Please use the link listed below to access the DEA Form 106.  This form needs to be submitted online to the DEA.

    Indiana law requires that the registrant notify the Indiana Board of Pharmacy in writing of any theft or significant loss of any controlled substances upon discovery of such theft or loss.  Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.  You will need to print a copy of the filed DEA Form 106 and submit a copy to the Indiana Board of Pharmacy by faxing 317.233.4236, e-mail to pla4@pla.IN.gov, or by mailing to 402 W Washington Street Rm W072, Indianapolis, Indiana, 46204.

    Report of Lost or Stolen Controlled Substances

Electronic Prescribing

  • E-Prescribing Information

    856 IAC 1-40:  Electronic Prescribing

    What is an electronic prescription?
    The only difference between a regular prescription and an electronic prescription is that an electronic prescription contains the electronic signature of the practitioner and is transmitted in accordance with relevant law.

    An e-prescription originates with the prescribing practitioner using a computer, sending the prescription through an approved electronic data intermediary ("EDI"), to a receiving pharmacy's computer.  The prescription software used by the prescriber must submit the prescription through an approved EDI in order for the e-prescription to be considered valid.

    E-prescribing does not include a prescription that is:

    • transmitted by facsimile, including those sent from a prescribing practitioner's computer to a receiving pharmacy's fax machine; or 
    • printed from the prescriber's computer. 

    What is an approved EDI?
    An EDI is an entity that provides the infrastructure that connects a computer system used by a prescribing practitioner with a computer system used by a pharmacy.  The EDI facilitates the secure transmission of an electronic prescription order, a refill authorization request, a communication, and other patient care information between a practitioner and a pharmacy.

    The EDI is required to submit an application and be approved by the Board.  An applicant for approval must submit an application and information regarding how they will guarantee the security of the prescription; the practitioner's identity and privacy; and the patient's identity, privacy, and confidentiality.

    EDI Application

    What is an electronic signature?
    An electronic sound, symbol, or process attached to or logically associated with an electronically transmitted prescription that is adopted by a person, who intends to sign the electronic prescription.

    Can controlled substances be electronically transmitted?
    IC 35-48-3-9 was updated to allow electronic prescribing of controlled substances, to follow federal law.  In order to electronically prescribe controlled substances, some of the major DEA requirements prescribers must adhere to include:

    • Use of an e-prescribing application that is certified for this purpose.
    • Completion of a compliant identity-proofing process.
    • Use of a secure, two-factor authentication process to sign prescriptions for controlled substances.

    A pharmacy cannot process electronic prescriptions for controlled substances until its pharmacy application provider obtains a third party audit or certification review that determines that the application complies with DEA's requirements and the application provider provides the audit/certification report to the pharmacy.

    For more information regarding the DEA's requirements for electronically prescribing and/or processing controlled substances, please visit the DEA's website at http://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html.

    Is a prescription that is sent via computer to a pharmacy's fax considered an electronic prescription?
    No.  A faxed prescription has requirements set out in 856 IAC 1-31-1; a faxed prescription must also meet the requirements of IC 16-42-22

    Questions?
    If you have any questions, please contact the Pharmacy Board at pla4@pla.IN.gov.

  • Approved Electronic Data Intermediaries

    EDI:  Advanced Answers on Demand/AOD Software
    11575 Heron Bay Blvd., Suite 200  Coral Springs, FL 33076
    Contact:  Doc DeVore
    Phone:  854-718-6422
    E-mail:  doc@aodsoftware.com
    Website:  http://www.AODSoftware.com/
    Approval Date:  05/11/2015

    EDI: MedAvant Healthcare Solutions
    1854 Shackelford Ct, Ste 200 Norcross, GA 30093
    Contact: Debra Roddenberry
    Phone: 770-806-4815
    E-mail: droddenberry@medavanthealth.com
    Website: http://www.medavanthealth.com/
    Approval Date: 04/17/2006

    EDI: Sure Scripts, LLC
    5971 Kingstowne Village Pkwy Ste 200  Alexandria, VA 22315
    Contact: Ken Whittemore, JR
    Phone: 703-921-2114
    E-mail: Ken.Whittemore@surescripts.com
    Website: http://www.surescripts.com/
    Approval Date: 04/17/2006

    EDI: Vision, by HealthMEDX
    5100 N Towne Centre Dr  Ozard, MO  65721
    Contact: Dan Cobb
    Phone: 417-449-3310
    E-mail:  dan.cobb@healthmedx.com
    Website: http://www.healthmedx.com
    Approval Date: 02/08/2010

    EDI: eHealth Solutions, Inc:  SigmaCare
    575 Eighth Avenue 15th Floor  New York, NY  10018
    Contact: G. Robert Russell
    Phone: 212-268-4242
    E-mail:  rrussell@sigmacare.com
    Website: http://www.sigmacare.com
    Approval Date: 01/10/2011

    EDI: Midwest Veterinary Supply, Inc.
    5374 Maly Road  Sun Prairie, WI 53590
    Contact: Brad Shaw
    Phone: 877-490-3576
    E-mail: brad.shaw@midwestvet.net
    Website: http://www.midwestvet.net/
    Approval Date: 11/14/2011

    EDI: Vetstreet, Inc.
    780 Township Line Road  Yardley, PA  19067
    Contact: Oliver Keane
    Phone: 240-599-2328
    E-mail: okeane@vetstreet.com
    Website: http://www.vetstreetpro.com/
    Approval Date: 04/16/2012

    EDI: Point Click Care
    6975 Creditview Road, Unit 4 Mississauga, Ontario Canada L5N8E9
    Contact: Catherine M.
    Phone: 800-277-5889
    E-mail: catherine.m@pointclickcare.us
    Website: http://www.pointclickcare.com/
    Approval Date: 1/14/2013

    EDI: Omnicare
    8351 W. Rockville Road Indianapolis, IN 46234
    Contact: Darold R. Barnes
    Phone: 800-772-7096
    E-mail: darold.barnes@omnicare.com
    Website: http://www.omnicare.com/
    Approval Date: 1/14/2013

    EDI: Matrix
    7690 Golden Triangle Drive, Eden Prairie, MN 55344
    Contact: Yuliya Pruzhanskaya
    Phone: 952-995-9752
    E-mail: yuliya@mdiachieve.com
    Website: http://www.mdiachieve.com
    Approval Date: 3/11/2013

    EDI: Emdeon Business Services (eRx Network)
    100 Lexington Street, Suite 400  Froth Worth, TX 76102-2759
    Contact: Dana Venable
    Phone: 866-379-6389
    E-mail: dvenable@emdeon.com
    Website: http://www.emdeon.com
    Approval Date: 05/13/2013

    EDI: Weno Exchange LLC
    8127 Mesa Drive, B206-201  Austin, Texas 78759
    Contact: Kevin Pauley
    Phone: 877-890-3726
    E-mail: Kevin@wenoexchange.com
    Website: http://www.wenoexchange.com
    Approval Date: 06/10/2013

    EDI: NTT DATA Long Term Care Solutions, Inc.
    8383 158th Avenue, Suite 100  Redmond, WA 98052
    Contact: Dave Brotten
    Phone: 425-307-2265
    E-mail: dave.brotten@nttdata.com
    Website: http://americas.nttdata.com/
    Approval Date: 4/14/2014

    EDI: Optimus EMR Inc.
    17802 SkyPark Circle, Suite 105  Irvine, CA 92614
    Contact: Craig Griffin
    Phone: 888-617-2457 x207
    E-mail: cgriffin@optimusemr.com
    Website: http://www.optimusemr.com
    Approval Date: 4/14/2014

    EDI: PrescribersConnection
    2095 Exeter Road, #80-102  Germantown, TN 38138
    Contact:  Sonya Oetting
    Phone: 855-793-9773
    E-mail: sonya.oetting@prescribersconnection.com
    Website: http://www.prescribersconnection.com
    Approval Date: 2/10/2015

    EDI:  American Health Tech
    574 Highland Colony Parkway  Ridgeland, MS  39157
    Contact:  Maria Arellano MS, RN
    Phone:  601-572-3147
    E-mail address:  marellano@healthtech.net
    Website:  www.healthtech.net
    Approval Date:  6/8/2015

    EDI: NewCrop, LLC
    1800 Bering Drive #600  Houston TX  77057
    Contact:  Larry Susnow, M.D.
    Phone:  707-253-2238
    E-mail address:  isusnow@newcroprx.com
    Website:  www.newcroprx.com
    Approval Date:  10/28/2015

    EDI:  OmniviewDr
    Omnicare Inc., 900 Omnicare Center, 201 East 4th Street Cincinnati OH 45202-4248
    Contact:  Darold Barnes, R.Ph.
    Phone:  (317) 273-1552 ext 53048
    Email address:  darold.barnes@omnicare.com
    Approval Date:  12/10/2012

    EDI: Precision Pharmacy Management
    31089 US HWY 19N  Palm Harbor FL  34684
    Contact:  Peter Bolos
    Phone:  (888)958-0261
    Email address:  pbolos@synergyrx.com
    Approval Date:  01/08/2018

    EDI: Office Ally, LLC uses Surescripts, LLC for an EDI
    2800 Crystal Drive   Arlington VA  22202
    Contact:  Chantal Germain
    Phone: (571) 303-0863
    email: chantal.germain@surescripts.com
    Approval Date:  8/11/2014

    EDI:  Kaleido Health Solutions
    2810 N. Church St., Suite 19204  Wilmington, DE 19802
    Contact:  Dr. Amina Chaudhry
    Phone:  (843) 303-9168
    email:  achaudhry@kaleido-health.com
    website: www.Kaleido-health.com
    Approval Date:  07/13/2020

    EDI:  FDB Vela
    701 Gateway Blvd., Ste 600, South San Francisco, CA 94080
    Contact:  Jason Reed, PharmD
    Phone:  (513) 594-5003
    email:  jason.reed@FDBVela.com
    website: www.fdbvela.com
    Approval Date:  10/04/2022

  • E-Prescribing Waivers

    The Indiana Board of Pharmacy, in anticipation of the mandatory electronic prescribing requirements effective Jan. 1, 2022, has promulgated emergency rules that allow practitioners to apply for a waiver from e-prescribing controlled substances. Statutorily created exemptions to the e-prescribing requirements may be found at IC 25-1-9.3-9; with authority granted to the Board of Pharmacy, in consultation with the Medical Licensing Board, to create a waiver which prescribers may apply for if they are unable to initially comply with the e-prescribing requirement. A copy of the rule may be found HERE.

    If a prescriber's application for a waiver is approved by the Board, it will run concurrent with the prescriber's controlled substance registration (CSR).  Therefore, a prescriber must renew their e-prescribing waiver if (1) their CSR has expired; and (2) the waiver is still needed to prescribe controlled substances. must be renewed alongside the practitioner’s registry, if needed.

    To Apply: 
    1. The Prescriber should login to, or create, their AccessIndiana account at the link above.
    2. Once logged in, select 'Initial Applications' from the left-hand column.
    3. Select 'Pharmacy Board' from the options, then select 'E-Prescribing Waiver'.
    4. Complete the prompts to submit the application to the Board of Pharmacy.

    NOTE:  A prescriber must identify which of the categories approved by the board they are eligible for, then complete the waiver request at the link below or submit a paper application found at the bottom of this this page.

    Recognized Exceptions
    1- A prescriber who demonstrates electronically transmitted prescriptions for controlled substances creates an economic hardship on behalf of the Prescriber.
    2- A prescriber who demonstrates electronically transmitted prescriptions for controlled substances is not possible due to technological limitations that are not reasonably within the control of the Prescriber.
    3- A prescriber who reasonably determines that it would be impractical for the individual involved to obtain an electronically transmitted prescription for controlled substances in a timely manner and such delay would adversely impact the individual’s medical condition.
    4- A prescription issued by a Prescriber under an approved research protocol.
    5- A prescription issued by a Prescriber for an individual who receives hospice care and that is not covered under the hospice benefit under 42 U.S. Code 1395 w-104.
    6- Prescriptions issued by a Prescriber for an individual who is a resident of a nursing facility, as defined in 42 U.S. Code 1396r. Waivers are not required for drug orders.
    7- A prescription issued by a Prescriber for an individual who is confined in a city or county jail.
    8- A prescription issued by a Prescriber that is a compounded prescription containing two (2) or more products.
    9- A prescription issued by a Prescriber that is a compounded infusion prescription containing two (2) or more products.

    To Renew:

    1. The prescriber should log into their AccessIndiana account at the link above.
    2. Once logged in, select "Renew" to the right of the prescriber's e-prescribing number.
    3. Complete the prompts to submit the renewal of the waiver to the Board of Pharmacy, ensuring that you provide documentation as to why you still require the waiver.

    Pharmacy Verification of Waivers
    If a pharmacist wants to verify if a prescriber has received a waiver from the Pharmacy Board, they can confirm utilizing PLA's Search & Verify Tool. This tool can be used to verify if the prescriber has an approved or pending application with the Board. A pharmacist can search using the waiver number, the prescriber's name, or the prescriber's CSR number.

    Prescribers who have pending waiver requests before the Board are authorized by the rule to indicate that a waiver is pending on their written or call-in prescriptions so that they may continue to prescribe for patients while the Board reviews their application. Pursuant to Indiana law, the pharmacist filling the prescription shall exercise their professional judgment in the best interest of the patient's health when reviewing all prescriptions and maintains ultimate discretion in filling the prescription.

    A copy of the application form can be found HERE.

  • Inspect Query Waiver Procedure

    MANDATORY QUERY – IC 35-48-7-11.1(k)

    A practitioner shall query INSPECT prior to prescribing a benzodiazepine or opioid. This is effective:

    • Immediately for any practitioner whose EHR is integrated with INSPECT.
    • January 1, 2019, for any services provided in an ER or pain management clinic.
    • January 1, 2020, for any services provided in a hospital
    • January 1, 2021, all other practitioners (immediately if EHR integrated with INSPECT)

    Query requirement exceptions:

    • If pain has signed a pain management contract, do not need to query more than once in a 90 day period
    • If granted a waiver from the Board due to lack of Internet access in practice location

    WAIVER REQUEST PROCEDURE

    1. Practitioner submits a written request for a waiver of the query requirement, by sending a letter to the Board or by emailing the Board at pla4@pla.in.gov.
    2. The written request should include the name and license number of the practitioner, the location of the practitioner’s place of business, and an explanation as to why the practitioner does not have access to Internet services.
    3. The written request will be saved to the practitioner’s electronic record kept by IPLA.
    4. The Board will review the request at their regularly scheduled meeting, and may ask the practitioner to make a personal appearance to answer any questions.
    5. The Board will then vote on whether to grant or deny a waiver request. A waiver will not be granted if the sole reason a practitioner does not have access to the Internet is that they do not want to pay for the service.
    6. The Board will send a letter to the practitioner notifying them of the Board’s decision.  This letter will also be maintained with the practitioner’s electronic file.
    7. The Board may rescind approval of a waiver if it receives information that the practitioner now has access to Internet services. This decision would be communicated and saved in the same manner described in #6 above.
    8. Waivers are granted for one year intervals only.  After one year, the practitioner will need to submit a new request.
  • DEA Requirements for Electronic Prescribing of Controlled Substances (EPCS)

    EPCS requires the individual practitioner be responsible for ensuring the prescription conforms to all legal requirements and the pharmacist, acting under the authority of the DEA-registered pharmacy, has a corresponding responsibility to ensure the prescription is valid and meets all legal requirements.

    In order to electronically prescribe controlled substances, some of the major DEA requirements prescribers must adhere to include:

    • Use of an e-prescribing application that is certified by a DEA approved entity.
    • Completion of a compliant identity-proofing process.
    • Use of a secure, two-factor authentication process to sign prescriptions for controlled substances.

    A practitioner cannot issue EPCS and a pharmacy cannot process them until its pharmacy application provider obtains a third party audit or certification review that determines that the application complies with DEA's requirements and the application provider provides the audit/certification report to the pharmacy.  Review of an EPCS application must be thorough in order to provide the prescriber and pharmacist the level of assurance needed in order to use the application.  For more information regarding these third-party reviews, please visit DEA's website at http://www.deadiversion.usdoj.gov/ecomm/e_rx/thirdparty.htm.

    For more information regarding the DEA's requirements for electronically prescribing and/or processing controlled substances, please visit the DEA's website at http://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html.

Pharmacy Compliance

Pharmacy Compliance

Additional Resources for Pharmacy

  • Statutes & Rules

    The Indiana Board of Pharmacy and the Indiana Professional Licensing Agency are prohibited from providing legal advice on issues contained in the laws and regulations.  For legal advice, please consult an attorney.

    TELEPHARMACY EMERGENCY RULE

    THIRD PARTY LOGISTICS PROVIDER EMERGENCY RULE

    CONVICTIONS OF CONCERN EMERGENCY RULE

    The most current version of the Indiana statutes and rules may be accessed using the citations below.

    LEGEND DRUGS AND DRUG REGULATION

    Title 16 Article 42. Regulation of Food Drugs and Cosmetics

    • Chapter 1. General Provisions
    • Chapter 3. Uniform Food Drug and Cosmetic Act: Adulteration and Misbranding of Drugs or Devices
    • Chapter 19. Drugs: Indiana Legend Drug Act
    • Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules
    • Chapter 21. Drug Samples
    • Chapter 22. Generic Drugs
    • Chapter 23. Drugs: Use of Amygdalin (Laetrile)
    • Chapter 24. Drugs: Use of Chymopapain
    • Chapter 25. Drugs: Biosimilar Biological Products
    • Chapter 26. Drugs: Investigational Drug, Biological Product, or Device
    • Chapter 27. Drugs: Overdose Intervention Drugs

    Title 35 Article 43 Offenses Against Property

    • Chapter 10. Legend Drug Deception

    GENERAL PROVISIONS

    Title 25 Article 0.5 Applicability of Certain Provisions in IC 25-1

    • Chapter 1. Initial License or Certificate under IC 25-1-1.1-4
    • Chapter 2. Permits, Licenses, Certificates of Registration, and Evidences of Authority under IC 25-1-2-2.1
    • Chapter 3. Entities under IC 25-1-2-6
    • Chapter 4. "Board" as used in IC 25-1-4
    • Chapter 5. Performance of Administrative Functions, Duties, and Responsibilities for Entities by the Indiana
      Professional Licensing Agency under IC 25-1-5-3
    • Chapter 6. "Provider" as used in IC 25-1-5-10
    • Chapter 7. Performance of Administrative Functions, Duties, and Responsibilities for Entities by the Indiana
      Professional Licensing Agency under IC 25-1-6-3
    • Chapter 8. "Regulated Occupation" for purposes of IC 25-1-7
    • Chapter 9. "Board" as used in IC 25-1-8
    • Chapter 10. "Board" as used in IC 25-1-8-6
    • Chapter 11. "Board" as used in IC 25-1-9
    • Chapter 12. "Board" as used in IC 25-1-11

    Title 25 Article 1. General Provisions 

    • Chapter 0.1. Effect of Certain Acts
    • Chapter 1.    Evidence of License Applicant's Payment of Personal Property Taxes Required
    • Chapter 1.1. Effect of Criminal Convictions on Licensed Persons
    • Chapter 1.2. Effect of Delinquency in Child Support Payments of Licensed Persons
    • Chapter 2.   Renewal of Licenses
    • Chapter 3.   Civil Immunity of Regulatory Agencies
    • Chapter 4.   Continuing Education
    • Chapter 5.   Professional Licensing Agency
    • Chapter 5.5 Electronic Registry of Professions
    • Chapter 6.   Professional Licensing Agency Functions and Duties
    • Chapter 6.5 Board Administration
    • Chapter 7.   Investigation and Prosecution of Complaints Concerning Regulated Occupations
    • Chapter 8.   Occupational and Professional Licensure, Registration, and Certification Fees
    • Chapter 9.   Health Professions Standards of Practice​
    • Chapter 9.1.  Out of Network Provider Referrals
    • Chapter 9.3. Electronically Transmitted Prescriptions for Controlled Substances
    • Chapter 9.5.  Telemedicine Services and Prescriptions
    • Chapter 9.7.   Prescribing and Dispensing of Opioids
    • Chapter 10. Direct Primary Care Agreements
    • Chapter 11. Professional Licensing Standards of Practice
    • Chapter 12. Renewal of Licenses Held by Individuals in Military Service
    • Chapter 13. Indiana Scheduled Prescription Electronic Collection and Tracking Program
    • Chapter 14. Repealed
    • Chapter 15. Exemption for Athletic Organization Practitioners Licensed in Other Jurisdictions
    • Chapter 16. Evaluation of Regulated Occupations
    • Chapter 17. Licensure of Individuals with Military Training; Licensure of Military Spouses
    • Chapter 18. Repealed
    • Chapter 19. Scleral Tattooing
    • Chapter 20. Effect of a State Disaster Emergency on Professional Disciplinary Action
    • Chapter 21. Reciprocity for Health Care Professionals

    Title 25 Article 26. Pharmacists, Pharmacies, Drug Stores

    • Chapter 13. Regulation of Pharmacists and Pharmacies; Creation of Board
    • Chapter 13.5. Remote Dispensing Facilities
    • Chapter 14. Wholesale Legend Drug Distributors
    • Chapter 16. Drug Regimens
    • Chapter 16.5 Drug Regimens in Health Facilities
    • Chapter 17. Nonresident Pharmacies
    • Chapter 18. Mail Order and Internet Based Pharmacies
    • Chapter 19. Regulation of Pharmacy Technicians
    • Chapter 20. Regional Drug Repository Program
    • Chapter 21. Home Medical Equipment Service Providers
    • Chapter 22. Pharmacy Audits
    • Chapter 23. Returning Unused Medication
    • Chapter 24. Central Repository for Controlled Substances Data

    CONTROLLED SUBSTANCES

    Title 35 Article 48 Controlled Substances

    • Chapter 1. Definitions
    • Chapter 2. Classification of Drugs
    • Chapter 3. Registration and Control
    • Chapter 4. Offenses Relating to Controlled Substances

    Synthetic Drugs

    • IC 35-31.5-2-321 "Synthetic drug"

    Title 856, Article 2 Controlled Substances

    • Chapter 1. Definitions
    • Chapter 2. Controlled Substances Code Number - Schedules I through IV
    • Chapter 3. Registration Information - Special Instructions
    • Chapter 4. Records and Inventories of Registrants
    • Chapter 5. Order Forms
    • Chapter 6.  Issuance; Filling and Filing Prescriptions
    • Chapter 7.  Limited Permits

    INSPECT

    See IC 25-1-13 and IC 25-26-24 above.

    ADMINISTRATIVE CODE

    Title 856, Article 1 Pharmacies and Pharmacists

    • Rule 1.  Application Requirements (Repealed)
    • Rule 1.1.  Definitions
    • Rule 2.  Pharmacists' Certificate
    • Rule 3.  Experience (Repealed)
    • Rule 3.1.  Examination and Experience Requirements
    • Rule 4.  Reciprocity
    • Rule 5.  Recognition of Accredited Schools
    • Rule 6.  Drugstores, Pharmacies, Apothecary Shops
    • Rule 6.1.  Drugstores, Pharmacies, Apothecary Shops
    • Rule 7.  Pharmacy Permits
    • Rule 8.  Known Pharmaceutical Manufacturer and Manufacturer - Definition
    • Rule 9.  Application for Prohibited Drugs (Repealed)
    • Rule 10.  Non-Drug Products (Repealed)
    • Rule 11.  Toxic Preparations (Repealed)
    • Rule 12.  Poisons (Repealed)
    • Rule 13.  General Definitions
    • Rule 14.  Physical Inventory of Merchandise (Repealed)
    • Rule 15.  Pharmacists' Notification of Termination
    • Rule 16.  New Pharmacist (Repealed)
    • Rule 17.  Practice of Pharmacy (Repealed)
    • Rule 18.  Narcotic License (Repealed)
    • Rule 19.  Adoption by Reference of U.S. Federal Rules Pertaining to Narcotics (Repealed)
    • Rule 20.  Violations and Penalties
    • Rule 21.  Resale of Returned Substances
    • Rule 22.  Narcotics - Defined (Repealed)
    • Rule 23.  Dispensing of Dangerous Drugs
    • Rule 24.  Hospital Pharmacies (Repealed)
    • Rule 25.  Internship for Apprentice Pharmacists (Repealed)
    • Rule 26.  Continuing Professional Education
    • Rule 27.  Fee Structure
    • Rule 28.  Institutional Pharmacies (Repealed)
    • Rule 29.  Electronic Data Processing of Prescriptions
    • Rule 30.  Sterile Pharmaceuticals; Preparation and Dispensing
    • Rule 31.  Facsimile Machines
    • Rule 32.  Transfer of Prescriptions Between Pharmacies
    • Rule 33.  Counseling
    • Rule 34.  Security Features for Prescriptions
    • Rule 35.  Pharmacy Technicians
    • Rule 36.  Temporary Variances
    • Rule 37.  Central Fill or Processing, of Both, of Prescriptions and Drug Orders
    • Rule 38.  Credit for Returned Expired Drugs
    • Rule 39.  Home Medical Equipment Service Providers
    • Rule 40.  Electronic Prescribing
    • Rule 41.  Cognitive Services
    • Rule 42.  Remote Pharmacy Practice

    Title 856, Article 3 Wholesale Legend Drugs

    • Rule 1.  Definitions
    • Rule 2.  Licensing and Operational Requirements
    • Rule 3.  Accreditation
    • Rule 4.  Pedigrees (Expired)
    • Rule 5.  Normal Distribution Chain of Custody
    • Rule 6.  Drug Returns (Expired)
    • Rule 7.  Authentications

    Title 856, Article 4 Pharmacist Vaccinations Administered via Protocol Authority

    • Rule 1.  Pharmacist Vaccinations Administered via Protocol Authority

    Title 856, Article 5  Automated Medication Systems

    • Rule 1.  Automated Medication Systems

    Title 856, Article 7  Prescription Drug Take Back Programs

    • Rule 1.  Purpose and Scope
    • Rule 2.  Definitions
    • Rule 3.  Responsibilities of Entities who Accept Unused or Unwanted Medications
    • Rule 4.  Policy Regarding Record Keeping
    • Rule 5.  Destruction Methods
    • Rule 6.  Privacy Protocols and Safeguards
    • Rule 7.  Security Standards
    • Rule 8.  Transportation Standards
    • Rule 9.  Liability and Immunity for Entities Operating a Take Back Program

    Additional Information

    • You can access the Indiana Code and the Indiana Administrative Code online via iga.IN.gov.
    • You can access associated federal regulations online via Title 21 of the Code of Federal Regulations.
  • Synthetic Drug Emergency Rules

    Indiana Code 25-26-13-4.1 gives the Indiana Board of Pharmacy the authority to adopt emergency rules declaring a substance to be a synthetic drug if the substance:

    1. has been scheduled or emergency scheduled by the United States Drug Enforcement Administration;
    2. has been scheduled, emergency scheduled, or criminalized by another state; or
    3. has:
      1. a high potential for abuse; and
      2. no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision.

    Controlled substances listed in IC 35-48-2-4 are included in Schedule I.  “Synthetic drugs,” as defined in IC 35-31.5-2-321, are listed as Schedule I drugs under IC 35-48-2-4(d)(35).  Indiana Code 35-31.5-2-321(13) includes in the definition of synthetic drug “any compound determined to be a synthetic drug by rule adopted under IC 25-26-13-4.1.”

    Emergency rules adopted by the Indiana Board of Pharmacy become effective thirty (30) days after filing with the publisher. Emergency rules adopted by the Board expire on June 30 of the year following the year in which the rules were filed with the publisher.

    The Indiana Board of Pharmacy has promulgated the following emergency rules in accordance with IC 25-26-13-4.1:

  • Pharmacy Board Frequently Asked Questions (FAQs)

    The following is for informational purposes only.  This does not and should not be construed as official legal advice or policy from the Indiana Board of Pharmacy.  Always review any state or federal regulations that may help answer your question, and if needed seek private counsel.  The Board is unable to provide specific legal advice.   This was last updated March 8, 2019.

    Does the Indiana Board of Pharmacy require compliance with USP 800?

    USP 800 is a standard developed by the United States Pharmacopeia and becomes effective December 1, 2019.  USP is not a regulatory body.  This means that the standards they develop are not legal requirements.  Their standards only become a legal requirement if the standards are adopted as state or federal law.  At this time, the Indiana Board of Pharmacy has not adopted USP 800, and legislation has not been introduced in the Indiana General Assembly either. If either occurs, the Indiana Board of Pharmacy will provide notice to all licensed pharmacies in the state. However, beware that other organizations, such as accrediting bodies, may require USP 800. It is best to consult with your private counsel to determine if any regulating body overseeing your operations requires compliance with USP 800.

    What are the required elements of a prescription?

    Under Indiana law, all prescriptions must have the following information:

    • Name and address of the patient
    • Name and strength or size of the drug or device
    • Amount to be dispensed
    • Adequate directions for the proper use of the drug or device by the patient
    • Name of the practitioner
    • Issued and signed by a practitioner, either in writing or electronically

    See IC 16-42-19-7.

    Additionally, all controlled substance prescriptions must also have the following information:

    • Dated as of, and signed, the day when issued
    • Name, address, and federal controlled substance registration number of the practitioner

    See 856 IAC 2-6-4

    Can a pharmacy accept a prescription that is printed on plain paper?

    Yes, provided all the required elements of a prescription are present.  However, the answer is no if the prescription is for a controlled substance.  All non-electronic prescriptions for a controlled substance must be printed on security paper that has been approved by the Indiana Board of Pharmacy.  A list of current approved security prescription paper providers can be found here: https://www.in.gov/pla/2538.htm.

    Prescriptions utilized by pharmacists to record call-in prescriptions, transferred prescriptions, or facsimile prescriptions do not need to use security prescription paper.

    Finally, the name of a controlled substance may not be preprinted on any prescription at any time before the prescription is being prepared and executed.  That includes such activities as typing prescriptions in anticipation of their need, or using a rubber stamp to accomplish the same end.  Commercially printed forms containing names of controlled substances are also prohibited.

    See 856 IAC 1-34.

    Can our pharmacy fill prescriptions written by physician assistants and nurse practitioners in another state?

    Yes.  A pharmacist may fill a prescription written by an out-of-state provider, provided they are licensed in that state, and the pharmacist has taken reasonable steps to determine whether the prescription was issued in compliance with the laws of the state where it originated.

    See IC 25-26-13-16

    What constitutes a change of ownership of a licensed facility?

    Pharmacy permits cannot be transferred between locations or owners.  If there is a change of ownership, an application for change of ownership should be made no later than 10 days after the change in ownership.  The original permit will remain valid until a new permit is issued or the application is rejected.

    Whether or not a change of ownership has occurred must be determined by the facility.  The ultimate inquiry is whether there has been a change in who has control over the operations of the facility.  Things to consider include a change in corporate identity, a change in a parent organization or a change of legal tax identification number.  A change of officers does not constitute a change of ownership if the corporate structure remains the same.  If in doubt, it best to obtain a new permit.

  • Internet Drug Outlet Identification Program

    The Internet Drug Outlet Identification Program is a program created by the National Association of Boards of Pharmacy.  The purpose of the program is to identify legitimate pharmacy websites.  Internet pharmacies should be evaluated carefully to determine whether they are engaged in the legitimate, safe practice of pharmacy.  A 2016 review of internet pharmacies purporting to be based in Canada found that 74% of them sourced their drugs from outside of Canada.  As of June 30, 2017, NABP has reviewed over 11,000 internet drug outlet websites.  A staggering 96% of these were operating outside of compliance with federal and state laws.  Most of these dispensed drugs without a valid prescription.

    NABP has created an ongoing list of internet pharmacies that it rates as "Recommended" or "Not Recommended."  Additionally, it has created the domain .pharmacy that legitimate internet pharmacies, who have been vetted by the program, can use.

    To access the list, please visit this page.

  • What is a Home Medical Equipment Services Provider

    For more information regarding the statutes and rules regulating home medical equipment services providers, please review them below.  

    For legal interpretations, please refer to your legal counsel; the Board office does not interpret the rules and regulations.  

    IC 25-26-21; 856 IAC 1-39:  Home Medical Equipment Service Providers

    Home Medical Equipment means equipment that:

    1. is prescribed by a health care provider;
    2. sustains, restores, or supplants a vital bodily function; and
    3. is technologically sophisticated and requires individualized adjustment or regular maintenance.

    The term includes, but is not limited to, the following:

    1. Continuous passive motion (CPM) machines;
    2. Patient lift devices;
    3. Defibrillators;
    4. Manual wheelchairs;
    5. Hospital-bed accessories;
    6. Electronically controlled or computerized wheel chairs and seating systems that are sold.

    This term does not include:

    1. walkers;
    2. ambulatory aids;
    3. commodes; or
    4. any other home medical equipment determined by the Board in 856 IAC 1-39.

    Home Medical Equipment Services means the:

    1. sale, rental, delivery, or installation; and
    2. installation, maintenance, and instruction in the use of medical equipment used by an individual that allows the individual to reside in a noninstitutional environment.

    A license is required to provide home medical equipment services to an unrelated individual in the individual's residence.  For more information on licensure, please go here.

    Additional Information
    For questions regarding the Indiana HME license, please contact our office by e-mail at pla4@pla.IN.gov.

  • Closing the Wholesale Drug Distributor Facility

    If you are closing out you Indiana wholesale drug distributor license due to closure of the facility or you are no longer shipping into or within Indiana, then you need to submit the closing information in writing to our office along with your original registration card.  This may be mailed to our office at the following address:

    Professional Licensing Agency
    402 W Washington Street, Room W072
    Indianapolis, Indiana  46204.

    If you have any questions, please contact our office at pla4@pla.IN.gov.

  • Who Needs a Wholesale Drug Distributor License

    For more information regarding the statutes and rules regulating wholesale drug distributors, please review them below. 

    For legal interpretations, please refer to your legal counsel; the Board office does not interpret the rules and regulations. 

    IC 25-26-14:  Wholesale Legend Drug Distributors
    856 IAC 3:  Wholesale Legend Drugs

    Any individual, partnership, limited liability company, corporation or business firm located in or outside Indiana and is physically distributing legend drugs or passing title into or within the state of Indiana is required to hold an Indiana wholesale drug distributor license as well as have obtained the Verified Accredited Wholesale Distributors (VAWD) accreditation.

    Indiana law requires wholesale drug distributors of legend drugs to obtain and maintain VAWD accreditation from the National Association of Boards of Pharmacy (NABP).  For more information regarding VAWD, including the accreditation process, VAWD application form, and instructions, please visit NABP's website at http://www.nabp.net/programs/accreditation/vawd/.

    Exceptions to Licensure
    The following entities are not required to obtain licensure, VAWD, or comply with the requirements of IC 25-26-14:

    1. FDA approved manufacturers (who distribute their own manufactured products);
    2. medical gas manufacturers or distributors that manufacture or distribute medical gases only; and
    3. veterinary supply distributors that distribute legend drugs that are FDA approved for animal use only.
    Wholesale Drug Distributor Defined
    "Wholesale drug distributor" means a person engaged in wholesale drug distribution of legend drugs, including:
    1. manufacturers
    2. repackers;
    3. own-label distributors;
    4. jobbers;
    5. brokers;
    6. warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses;
    7. independent wholesale drug traders;
    8. retail and hospital pharmacies that conduct wholesale distributions; and
    9. reverse distributors.

    This term does not include a common carrier or person hired solely to transport prescription drugs.

    Legend Drug Defined
    "Legend drug" means a drug that is subject to 21 USC 353(b)(1) or is listed in the Prescription Drug Product List published in the US Department of Health and Human Services Orange Book:  Approved Drug Products with Therapeutic Equivalence Evaluations.  The term includes any human drug required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to 21 USC 811 through 812.  The term does not include a device or a device component, part, or accessory.

    Wholesale Distribution Defined
    "Wholesale distribution" means to distribute legend drugs to persons other than a consumer or patient.

    The term does not include:

    1. a sale or transfer between a division, a subsidiary, a parent, an affiliated, or a related company under the common ownership and control of a corporate entity;
    2. the purchase or acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for the hospital's or health care entity's own use from the group purchasing organization or from other hospitals or health care entities that are members of the organization;
    3. the sale of a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code, to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
    4. the sale of a drug among hospitals or other health care entities that are under common control;
    5. the sale of a drug for emergency medical reasons, including transfers of legend drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, if the gross dollar value of the transfers does not exceed five percent (5%) of the total legend drug sales revenue of either the transferor or transferee pharmacy during any twelve (12) consecutive month period;
    6. the sale of a drug or the dispensing of a drug pursuant to a prescription;
    7. the distribution of drug samples by manufacturers' representatives or distributors' representatives;
    8. the sale of blood and blood components intended for transfusion;
    9. the sale of a drug by a retail pharmacy to a practitioner (as defined in IC 25-26-13-2) for office use, if the gross dollar value of the transfers does not exceed five percent (5%) of the retail pharmacy's total legend drug sales during any twelve (12) consecutive months;
    10. the sale of a drug by a retail pharmacy that is ending its business and liquidating its inventory to another retail pharmacy;
    11. drug returns by a hospital, health care entity, or charitable institution conducted under 21 CFR 203.23;
    12. the sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use;
    13. the distribution of prescription drugs by the original manufacturer of the finished form of the prescription drug or the distribution of the co-licensed products by a partner of the original manufacturer of the finished form of the prescription drug; or
    14. drug returns that meet criteria established by rules adopted by the board.

    Questions
    If you have additional questions, please e-mail our office at pla4@pla.IN.gov.

  • PSE and Ephedrine Retailer Requirements & Purchase LImits

    As of July 1, 2011, Senate Enrolled Act 503 made certain changes to the ephedrine and pseudoephedrine laws in the State of Indiana, specifically to the purchase limits, electronic tracking of drugs purchased, and convenience package storage areas.

    PSE and Ephedrine Purchase Limits (for both regular and convenience package sales)
    As of July 1, 2011, the new law changed the ephedrine and pseudoephedrine limits that may be purchased by an individual in the following ways:

    1. 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 seven and two-tenths (7.2) grams of ephedrine or pseudoephedrine, or both, in a thirty (30) day period.  These limits apply to the total amount of base ephedrine and pseudoephedrine contained in the products and not to the overall weight of the products.
    2. A person may not purchase drugs containing more than sixty (60) milligrams of ephedrine or pseudoephedrine, or both, in any one (1) transaction if the drugs are sold in a convenience package.

    Retailer Requirements and Electronic Sales TrackingAs of July 1, 2011, a retailer may sell a nonprescription drug that contains the active ingredient of ephedrine, pseudoephedrine, or both only if the retailer complies with the following conditions (a "retailer" is defined as a grocery store, general merchandise store, drug store, or other similar establishment where PSE or ephedrine products are available for sale):

    1. The retailer does not sell the drug to a person less than eighteen (18) years of age.
    2. The retailer does not sell drugs containing more than three and six-tenths (3.6) grams of ephedrine or pseudoephedrine, or both, to one (1) individual on one (1) day, or seven and two-tenths (7.2) grams of ephedrine or pseudoephedrine, or both, to one (1) individual in a thirty (30) day period.
    3. The retailer requires:
      1. the purchaser to produce a valid government issued photo identification card showing the date of birth of the person;
      2. the purchaser to sign a written or electronic log attesting to the validity of the information; and
      3. the clerk who is conducting the transaction to initial or electronically record the clerk's identification on the log. Records from the completion of a log must be retained for at least two (2) years.
    4. The retailer maintains a record of information for each sale of a nonprescription product containing pseudoephedrine or ephedrine. Required information includes:
      1. the name and address of each purchaser;
      2. the type of identification presented;
      3. the governmental entity that issued the identification;
      4. the identification number; and
      5. the ephedrine or pseudoephedrine product purchased, including the number of grams the product contains and the date and time of the transaction.
    5. Beginning January 1, 2012, a retailer shall, except as provided in subdivision (6) listed below, before completing a sale of an over-the-counter product containing pseudoephedrine or ephedrine, electronically submit the required information to the National Precursor Log Exchange (NPLEx) administered by the National Association of Drug Diversion Investigators (NADDI), if the NPLEx system is available to retailers in the state without a charge for accessing the system. The retailer may not complete the sale if the system generates a stop sale alert.  (For more information regarding tracking program requirements, please visit our website at http://www.in.gov/pla/3265.htm)
    6. If a retailer selling an over-the-counter product containing ephedrine or pseudoephedrine experiences mechanical or electronic failure of the electronic sales tracking system and is unable to comply with the electronic sales tracking requirement, the retailer shall maintain a written log or an alternative electronic recordkeeping mechanism until the retailer is able to comply with the electronic sales tracking requirement.
    7. The retailer stores the drug 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.
    8. The retailer posts a sign warning that:
      1. it is a criminal offense for a person to purchase drugs containing more than seven and two-tenths (7.2) grams of ephedrine or pseudoephedrine, or both, in a thirty (30) day period;
      2. it is a criminal offense for a person to purchase drugs containing more than three and six-tenths (3.6) grams of ephedrine or pseudoephedrine, or both, on one (1) day; and
      3. depending on the amount of ephedrine or pseudoephedrine contained in the drug, purchasing more than one (1) package of drugs containing ephedrine or pseudoephedrine on one (1) day may be a crime.

    The warning sign must list the new maximum amounts of ephedrine or pseudoephedrine that may be purchased in both grams and milligrams. Please make sure that you have new signage in place reflecting the new limits!

    Storage and Sales Area for a Retailer Selling Convenience Packages
    As of July 1, 2011, a retailer may not sell drugs containing more than sixty (60) milligrams of ephedrine or pseudoephedrine, or both in any one (1) transaction if the drugs are sold in convenience packages. A retailer who sells convenience packages must secure the convenience packages behind the 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.

  • PSE and Ephedrine Reporting Requirements

    As a result of Legislation passed during the 2011 Legislative Session of the Indiana General Assembly, retailers (including pharmacies, out-patient prescription centers of hospitals, and practitioners selling out of their offices) that sell nonprescription pseudoephedrine (PSE) and/or ephedrine based products direct to consumers are now required to electronically report those sales to the State of Indiana via an online database.  Specifically, Senate Enrolled Act 503 requires submission of this data via the National Precursor Log Exchange System (NPLEx) being administered by the Appriss Corporation in conjunction with the National Association of Drug Diversion Investigators (“NADDI”), the Indiana Sheriffs’ Association, and the Indiana State Police.

    At this time, the Indiana Board of Pharmacy is NOT maintaining this database or receipt of information – licensees must work directly with the vendor to achieve compliance. However, starting in January 2012, the Board will be checking during routine quality assurance inspections to ensure that pharmacies have been contacted by Appriss and are successfully reporting sales data to the system.

    This electronic sales tracking system is a web-based and/or point-of-sale based technology solution that will allow retailers to automatically report sales of PSE and ephedrine to the vendor before completing a sale and prohibits a retailer from completing a sale if NPLEx generates a "stop sale" notice; the data contained in the NPLEx shall be forwarded to the State of Indiana.  If your pharmacy sells nonprescription pseudoephedrine (PSE) and/or ephedrine based products direct to consumers, please request an NPLEx account by visiting www.nplexsurvey.com. Click on the link for Indiana and then on the survey link for pharmacies.

    For additional information on the new system, compatibility, and how the system will work, please contact Appriss, Inc. at INNPLEx@appriss.com, 1-855-786-7539, or review the material being made available at the following links:

    1. http://www.nplexservice.com/
    2. http://www.nplexanswers.com/
    3. http://www.nplexsurvey.com/

    Also, click here to read a notification from the Indiana Sheriffs' Association providing additional detail concerning this project and the enforcement and compliance timelines.

    For additional information on this new law, please see the link provided above for SEA 503.  This Act also contains additional information on stop sale alerts, permissible quantities to sell, and compliance requirements.

  • Display of Licenses in Pharmacy

    The pharmacy permit and controlled substance registration as well as licenses of all pharmacists, pharmacist interns, technicians, and techncians-in-training shall be prominently displayed in an area where customers at the prescription counter can readily see them.

  • Closing of Pharmacy

    IC 25-26-13-27:  Closing of Pharmacies

    If a pharmacy will be closed for five (5) consecutive days or more, the permit holder shall notify their Board Compliance Officer and take such steps to secure the drugs in the pharmacy as the Compliance Officer may direct.

    If a pharmacy is to be permanently closed for any reason, the owner or qualifying pharmacist shall notify the Board office, not less than twenty (20) days before the transfer of any controlled substances, at pla4@pla.in.gov or 317.234.2067 to schedule a closing inspection.

  • Transferring Indiana Intern Hours to Another State

    If you are seeking a pharmacist license in another state, and require your Indiana intern hours to be transferred to that state, you must make a request in writing to our office.  The written request must include your Indiana pharmacist intern registration number, where to send the hours, and a $10 fee; the fee must be in the form of a check or money order made payable to the "Professional Licensing Agency".  The request and fee must be submitted to the Indiana Board of Pharmacy at the following address:

    Professional Licensing Agency
    402 West Washington Street, Room W072
    Indianapolis, IN 46204

  • What is a Pharmacy Technician

    IC 25-26-19:  Regulation of Pharmacy Technicians
    856 IAC 1-35:  Pharmacy Technicians

    A pharmacy technician is an individual, licensed by the Indiana Board of Pharmacy, who works under the direct supervision of a licensed pharmacist and assists the pharmacist in the technical and nonjudgmental functions related to the practice of pharmacy in the processing of prescriptions and drug orders.  The pharmacist is responsible for the work performed by the pharmacy technician.

    A pharmacy technician cannot legally work in the State of Indiana unless they have received their “blue card” license from the Board; an individual who knowingly practices as a pharmacy technician without being licensed commits a Class D felony.

    Prohibited activities

    1. providing advice or consultation with the prescribing practitioner regarding the patient or the interpretation and application of information contained in the prescription or drug order, medical record, or patient profile;
    2. providing advice or consultation with the patient regarding the interpretation of the prescription or the application of information contained in the patient profile or medical record;
    3. dispensing prescription drug information to the patient;
    4. final check on all aspects of completed prescription, including appropriateness of drug and accuracy of the drug dispensed, strength of the drug dispensed, and labeling of the prescription;
    5. receiving a new prescription over telephone or electronically unless original information is recorded so a pharmacist may review it (refill approval or denial is OK);
    6. any activity required by law to be performed only by a pharmacist;
    7. any activity that requires clinical judgment of a pharmacist.

    Identification in Pharmacy

    The public must be able to distinguish between a pharmacist and pharmacy technician.  A pharmacy technician shall wear identification stating they are a pharmacy technician and they must identify themselves verbally in any telephone or electronic communication as a pharmacy technician. The pharmacy technician is required to also post their license ("blue card") in the same location as the pharmacists’ licenses.

    Records Required

    A record of the pharmacy technician training and education must be maintained in the pharmacy where the technician is employed and shall include the following:

    1. the name of the technician;
    2. the starting date of employment as a pharmacy technician;
    3. the starting date of the technician training program;
    4. the completion date of the training program or proof of passing the board approved certification examination, if successfully completed;
    5. a copy of the training manual, if on-the-job training is used by the employer, or certificate of successful completion of another approved program, or other training program completed prior to employment.

    The Technician Training Program

    The contents of the training program include specific training in duties required to assist a pharmacist in the technical functions associated with the practice of pharmacy, and shall include, at a minimum, the following:

    1. understanding the duties and responsibilities of the technician and the pharmacist, including the standards of patient confidentiality and ethics governing pharmacy practice;
    2. tasks and technical skills, policies, and procedures related to the technician's position;
    3. working knowledge of the pharmaceutical-medical terminology, abbreviations, and symbols commonly used in prescriptions and drug orders;
    4. working knowledge of the general storage, packaging, and labeling requirements of drugs, prescriptions, or drug orders;
    5. ability to perform the arithmetic calculations required for the usual dosage determinations;
    6. working knowledge and understanding of the essential functions related to drug purchasing and inventory control; and
    7. the record keeping functions associated with prescriptions and drug orders.
  • Compliance Officers & Counties Inspected
    Regional Map for Board of Pharmacy Compliance Officers - Coming Soon
    Zaneta Nunnally
    Compliance Director
    317.753.3890

    Compliance Officers:
    Tim Thomas 317.753.4000
    Bret Busby317.503.4791
    Lana Conroy317.450.8141
    Lorena Terry317.775.3276
    Kimberly Russell812.489.3249
    Melissa Gresham812.569.2550
    Dianna Geier317.450.9438
    Ronald Hinderliter812.459.5382
    Michael Shannon317.719.9339
    Courtney Calvert317.460.5190
  • Security Feature Prescription Pad Provider Information

    All controlled substance prescriptions written by Indiana licensed practitioners [as defined by IC 16-42-19-5] must comply with DEA regulations and 856 IAC 1-34 in order for their prescriptions to be accepted for filling in Indiana licensed pharmacies.  A listing of approved security feature prescription pad vendors may be found below.

    Indiana Security Feature Prescription Pad Provider Application
    Indiana Security Feature Prescription Pad Provider Template

    To view approved providers of Security Feature Prescription Paper, click here.

    Application Information
    Printers wishing to supply prescription blanks to authorized recipients must submit the above application and a proof to be reviewed by the Board.  If approved, the printer will be added to our list of approved providers of security feature prescription paper.  If you are not approved by the Indiana Board of Pharmacy to provide security feature prescription paper to authorized recipients, you cannot do so until you are approved.

    Please note that your organization does not need approval to conduct prescription security paper business in Indiana under the following circumstances:

    1. Your company does not take possession of prescription security paper (e.g. you operate as an independent sales representative or broker); or
    2. Your company does not physically sell directly to a prescriber (e.g. your company manufacturers base stock which is delivered to a distributor for sale directly to a prescriber).

    Security Feature Prescription Pad Requirements
    All controlled substance prescriptions must contain the following security features:

    1. A latent, repetitive "void" pattern in reflex blue must appear across the entire face of the document when the prescription is photocopied;
    2. A watermark reading "Indiana Security Prescription" must be printed on the back of the paper; these words must appear at a 45 degree angle, horizontally in a step-and-repeated pattern in 5 lines, using 12-point Helvetica bold type style;
    3. An opaque RX symbol must appear in the upper right-hand corner corner, 1/8 of an inch from the top and 5/16 of an inch from the right side.  This symbol must be 3/4 of an inch and disappear if the prescription copy is lightened;
    4. Six (6) quantity check-off boxes and the following quantities must be printed on the form and the appropriate box checked off:  "1-24", "25-49", "50-74", "75-100", "101-150", and "151 and over";
    5. No advertisements may appear on the front or back;
    6. Logos may appear in the upper left one-inch square;
    7. Only one prescription may be written per blank.  The following statement must be printed on the bottom of the pad:  "Prescription is void if more than one (1) prescription is written per blank.";
    8. Refill options that can be circled must appear below any logos and above the signature lines on the left side of the prescription in the following order:  "Refill NR 1 2 3 4 5 Void after _____"
    9. Practitioner full name, address, DEA number, and state issued license number must be preprinted, stamped, or manually printed on the prescription;
    10. All prescription blanks must be 4 1/4 inches high and 5 1/2 inches wide;
    11. Two signature lines printed at the bottom of the form:  under the blank line on the left side must be printed the words "Dispense as Written", under the blank line on the right side must be printed the words "May Substitute".
    12. The name of any controlled substance may not be preprinted on any prescription forms at any time prior to the prescription being prepared and executed for presentation to the patient or the patient's agent.  That includes, but is not limited to, typing prescriptions in anticipation of their need and/or using a rubber stamp or similar means to accomplish the same end.  Commercially printed forms containing names of controlled substances are also prohibited.

    Questions
    If you have any questions, please email the Indiana Board of Pharmacy at pla4@pla.IN.gov.

  • Change of Officer

    Indiana law requires that a nonresident pharmacy must notify the Board of Pharmacy within thirty (30) days after any change of corporate officer.

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