Application for Pharmacy Permit
Application for Controlled Substance Registration
Pharmacy Inspection Questions
The Board shall issue a pharmacy permit to a facility that:
- submits a completed application for pharmacy permit and $100 application fee;
- submits a completed application for controlled substances registration and $100 application fee;
- submits a drawing or blueprint of your proposed licensed area (clarification on whether your licensed area is just the prescription department or the entire store is required);
- sets forth the name of the Indiana licensed pharmacist who will be in full responsible charge for the legal operation of the pharmacy (qualifying pharmacist; please make sure the named pharmacist is not listed as the "QP" on another pharmacy permit);
- successfully completes an inspection conducted by an Indiana Board of Pharmacy Compliance Officer.
Professional Licensing Agency
Applicants must submit a $100 Pharmacy permit application fee and $100 CSR application fee (if applicable) in the form of a check or money order made payable to the "Professional Licensing Agency". The fees may be combined into one check or money order. The fee(s) must be submitted with the application to the following:
402 W Washington Street, Room W072
Indianapolis, IN 46204.
What Do I Submit With The Completed Application for a Pharmacy Permit?
→ $100 pharmacy application fee and, if applicable, $100 CSR application fee;
→ drawing or blueprint showing physical size (include linear dimensions) and general layout of the floor plan; show the location of the prescription counter top with dimensions, location of the refrigerator, and prescription sink;
→ if you answered “yes” to either of the Inquiry of Law Violations questions on page 3 of the application, then you must explain fully, including all related details, in a signed and notarized statement. You must also submit documentation regarding to the incident(s) in question.
Prior to opening the pharmacy, the permit holder shall submit the premises to a qualifying inspection by an Indiana Board of Pharmacy Compliance Officer. Upon receipt of all requested information, the Board office will contact the individual listed on the application to schedule an inspection.
The pharmacy will be located separate and apart from any area containing merchandise not offered for sale under the pharmacy permit. The pharmacy will:
Sterile Pharmaceutical Physical Requirements: 856 IAC 1-30
- be stationary;
- be sufficiently secure, either through electronic or physical means, or a combination or both, to protect the products contained in the pharmacy and to detect and deter entry during those times when the pharmacy is closed;
- be well lighted and ventilated with clean and sanitary surroundings;
- be equipped with a sink with hot and cold running water, a proper sewage outlet, and refrigeration;
- have such additional fixtures, facilities and equipment as the Board requires to enable it to operate properly as a pharmacy in compliance with federal and state laws and regulations governing pharmacies; the qualifying pharmacist shall consider minimum health, safety, and security measures as well as the type and scope of practice, the patient's needs, and the laws and rules that apply;
- not be located in a place of residence;
- the wholesale value of the drug inventory on the licensed items must be at least 10% of the wholesale value of the items in the licensed area.
A licensed pharmacy preparing sterile pharmaceuticals shall have a designated area for preparing compounded, sterile pharmaceuticals. The designated area shall:
- be restricted to only those personnel authorized for preparation;
- be in a separate room or in a portion of a larger room but cannot be a warehouse or a stockroom setting;
- be free of dust and dirt;
- be used only for the preparation of sterile pharmaceutical products and related functions;
- have the equipment as required in 856 IAC 1-30-8(c);
- maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products as required in 856 IAC 1-30-8(d);
- have a current copy of Occupational Safety and Health Administration requirements for handling hazardous drugs as published by Occupational Safety and Health Administration,Office of Occupational Medicine, Directorate of Technical Support, Occupational Safety and Health Administration, U.S. Department of Labor;
- maintain a policy and procedure manual relating to the compounding, dispensing, delivery, administration, storage, and use of sterile pharmaceutical products, pursuant to prescriptions or drug orders, or both, as part of the pharmacy policy and procedure manual or as a separate policy and procedure manual; specific requirements may be found in 856 IAC 1-30-7.
Prescription Monitoring Program - INSPECT
The Indiana Scheduled Prescription Electronic Collection and Tracking (INSPECT) program is designed to serve as a tool to address the problem of prescription drug abuse and diversion in Indiana. By compiling controlled substance information into an online database (PMP Webcenter), INSPECT performs two critical functions:
- it maintains a warehouse of patient information for health care professionals, and
- it provides an important investigative tool for law enforcement.
Visit INSPECT's website at www.in.gov/pla/inspect/ for reporting requirements and registration information.
PSE and Ephedrine Reporting Requirements - NPLEx
If your pharmacy sells nonprescription pseudoephedrine (PSE) and/or ephedrine based products direct to consumers, you are required to electronically report those sales to the State of Indiana via the National Precursor Log Exchange System (NPLEx). This program is 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. Registration information can be found on our website.
Please visit our website for more information regarding retailer requirements and purchase limits.
Classes of Pharmacy Permits
The board has established three categories of pharmacy permits as follows:
Category II. An institutional permit for hospitals, clinics, health care facilities, sanitariums, nursing homes, or dispensaries that offer pharmaceutical care by dispensing a drug product to an inpatient under a drug order or to an outpatient of the institution under a prescription.
Category III. A permit for a pharmacy that provides closed door, central fill, mail order, or other processing operations that are not open to the general public but include: (A) traditional pharmacy functions; or (B) nontraditional pharmacy functions, such as infusion, nuclear pharmacy, or sterile compounding.
- Category I. A retail permit for a pharmacy that provides pharmaceutical care to the general public by the dispensing of a drug or device.
After June 30, 2012, a person with:
- a Type I permit shall be treated as holding a Category I permit;
- a Type II permit shall be treated as holding a Category II permit; and
- a Type III, IV, V, or VI permit shall be treated as holding a Category III permit.
If you have any questions, please contact our office at pla4@pla.IN.gov.