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Pharmacy Resources

Additional Resources for Pharmacy

  • 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.

  • 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.

  • 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.
  • 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