Adding a Remote Location to an Existing Pharmacy
The Board may approve a remote location operated by a hospital with a Type II permit that submits the following [IC 25-26-13-17(d)]: SPECIFIC APPLICATION INFORMATION AND DOCUMENTATION REQUIRED → Completed "Application for Operating a Remote Location" Page two (2) of the application lists all required documentation. The signature line on this page is REQUIRED to be signed by the qualifying pharmacist of the pharmacy responsible for the proposed remote location site. → *Application Fee If the proposed remote location site WILL be storing, administering, and/or dispensing controlled substances, and you have indicated this on the remote location application, then the application fee is $150. → Drawing or Blueprint → Site Map Additional Required Attachments, Specific to the Proposed Remote Location Site → Statement of Explanation → Type of Site → Personnel Responsible → Detailed Policies and Procedures → Inventory → If the site is an IV room, USP 797 compliance information → Storage and Security (Security and Storage Requirements may be found in 21 CFR 1301.71 – 1301.76 and 856 IAC 2-3-30 – 856 IAC 2-3-35) ***After all required application(s), fee(s), and documentation are received in the Board office and reviewed, the Board may require clarification on documentation or additional information by requesting your pharmacy schedule a personal appearance at a regularly scheduled Board meeting. Upon approval by the Board, the Board office will contact the named individual listed on the application to schedule an inspection. Professional Licensing Agency Questions?
Application for Operating a Remote Location
Page one (1) of the application must be completed in full: responsible pharmacy's information, proposed remote location's information, as well as an inquiry of law violations. If the applicant answers "yes" to any of the Inquiry of Law Violations questions, the applicant must explain fully, including all related details, in a signed and notarized statement. All related documentation regarding the incident(s) in question must also be submitted.
If the proposed remote location site will not be storing, administering, or dispensing controlled substances, then the application fee is $50.
Provide a drawing or blueprint showing the physical size (include dimensions) and general layout of the current licensed pharmacy area as well as one of the proposed remote location site.
Provide a map indicating the location of the current licensed pharmacy area as well as the proposed remote location, advising of distance between locations; include physical addresses of both sites.
Provide a statement or memorandum providing the Board with a general description of the proposed business plan and explain the need for the remote location.
Indicate the type of site the proposed remote location will be. Examples include a distribution site, university clinic, rehabilitation facility, warehouse, nuclear pharmacy, retail, hospital, etc.
Provide a list of the names, titles, and license numbers (if applicable) of all personnel that will be responsible for the operations.
1. If applicable, explanation of automation and information including:
a. auxiliary procedures for down time and
b. prescription files back-up information;
2. Authorized personnel with access at the remote site;
3. Qualifying pharmacist responsibilities, including availability to the site;
4. Handling of legend drugs at the remote site:
a. medication delivery,
b. restocking, and
c. inventory reconciliation.
Include an inventory listing of all legend drugs to be stored, including form and quantities.
1. Hood inspection reports;
2. Clean room procedures;
a. weekly, monthly cleaning logs,
b. proper disposal containers,
c. training/testing requirements for technicians, available upon request, and
d. equipment monitoring (hoods, refrigerators, etc.).
Provide the following regarding the storage and security of controlled substances:
1. Delivery of drugs from main site to proposed remote location site:
a. personnel responsible;
b. type of vehicle; and
c. containers which provide adequate security to guard against in-transit losses.
2. The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system);
3. The type of closures on vaults, safes, and secure enclosures; and
4. Controls and procedures to guard against theft and diversion:
a. electronic monitoring (motion, alarm, etc.);
b. human monitoring (guards, police, etc.);
c. cameras;
d. other (lockboxes, cages, gates, safe, etc.).
Fee Information
Applicants must submit the required application fee in the form of a check or money order made payable to the "Professional Licensing Agency". The fee must be submitted with the application to the following:
402 W Washington Street, Room W072
Indianapolis, IN 46204.
If you have any questions, please contact our office at pla4@pla.IN.gov or your local Compliance Officer.
