Controlled Substance Prescriptions

• Controlled Substance Prescriptions
  • Drug Enforcement Administration (DEA) - Practitioner's Manual
  • Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies

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  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 PaperAll 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.

• Suspicious Order Reporting

  Suspicious Order Reports can now be submitted online!

  CLICK HERE TO FILL OUT YOUR SUSPICIOUS ORDER REPORT

Additional Resources for Pharmacy

• Statutes & Rules

  Indiana Statutes

  Title 16 Article 42.- Regulation of Food Drugs and Cosmetics

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

  Title 25 Article 1 - Professions and Occupations

  Title 25 Article 26. Pharmacists, Pharmacies, Drug Stores

  Title 35 Article 43 - Offenses Against Property

  Title 35 Article 48 Controlled Substances

  Indiana Administrative Rules

  Title 856 - Article 1 Pharmacies and Pharmacists

• 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:

  • LSA #19-684(E) 
  • LSA #19-421(E)
  • LSA #19-380(E)
  • LSA #19-322(E)
  • LSA #18-516(E)
  • LSA #18-409(E) 
  • LSA #18-326(E)
  • LSA #18-250(E)
  • LSA #18-108(E)
  • LSA #18-58(E) 
  • LSA #17-568(E) 
  • LSA #17-446(E)
  • LSA #17-296(E)
  • LSA #16-535(E)
  • LSA #16-449(E)
  • LSA #15-188(E)
  • LSA #15-150(E)
  • LSA #14-448(E)
  • LSA #14-178(E)
  • LSA #14-177(E)
  • LSA #13-562(E)
  • LSA #13-305(E)
  • LSA #13-27(E)
  • LSA #12-590(E)
  • LSA #12-493(E)
• 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 Busby	317.503.4791
  Lana Conroy	317.450.8141
  Lorena Terry	317.775.3276
  Kimberly Russell	812.489.3249
  Melissa Gresham	812.569.2550
  Dianna Geier	317.450.9438
  Ronald Hinderliter	812.459.5382
  Michael Shannon	317.719.9339
  Courtney Calvert	317.460.5190

• 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.

  • Change of Officers (for use when an organizational change does not rise to the level of ownership change) This information may be emailed to pla4@pla.in.gov
• Related Links
  • Drug Watch
  • HoosierRx
  • Pharmacist Recovery Network (PRN)
  • U.S. Food and Drug Administration (FDA)
  • U.S. Drug Enforcement Administration (DEA)
  • National Association of Drug Diversion Investigators (NADDI)
  • National Association of Boards of Pharmacy (NABP)
  • Apply for a National Provider Identifier (NPI)
  • National Council for Prescription Drug Programs (NCPDP)
  • Indiana Pharmacists Alliance
  • Accreditation Council for Pharmacy Education (ACPE)
  • Indiana Department of Environmental Management (IDEM) - Prevent Pollution by Properly Disposing Unwanted Medicines
  • Collecting Unwanted Medications - An Indiana guide to holding unwanted medication collections for pharmacies and community organizations.
  • Indiana Department of Education (IDOE) - School Health Services
  • IU Center for Health Policy
  • Indiana Pharmacy Inspection Checklist
• Scope of Practice Rulings

  Licensed practitioners that have a specific question or questions about the scope of practice of their licensed profession may request a "practice ruling" from the Indiana Professional Licensing Agency (PLA) and the Indiana Board of Pharmacy (the Board). The PLA and the Board may provide a formal determination/interpretation based on the practitioner's factual situations/circumstances. Licensed practitioners may submit a "Request for Practice Ruling" through the web-based form provided on the PLA's "Request for Practice Ruling" web page. Additional information and instructions for submitting a "Request for Practice Ruling " are provided on the web page.

  All requests will be reviewed by the PLA's legal team, and PLA's legal team will draft a ruling for the Board's consideration and potential adoption. All rulings adopted by the Board will be posted to the Indiana Register as well as the comprehensive list provided on the the PLA's "Request for Practice Ruling" web page.