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)]:
- A completed "Application for Operating a Remote Location" along with the required application fee*;
- A drawing or blueprint of the current licensed pharmacy area as well as one of the proposed remote location site;
- A map indicating the location of the current licensed pharmacy area as well as the proposed remote location; and
- All required additional documentation as listed below, preferably in a tabbed binder or folder for presentation and review by the Board. Also include a cover letter or table of contents as the first page for organization purposes.
SPECIFIC APPLICATION INFORMATION AND DOCUMENTATION REQUIRED
→ Completed "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.
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 not be storing, administering, or dispensing controlled substances, then the application fee is $50.
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
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.
→ Site Map
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.
Additional Required Attachments, Specific to the Proposed Remote Location Site
→ Statement of Explanation
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.
→ Type of Site
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.
→ Personnel Responsible
Provide a list of the names, titles, and license numbers (if applicable) of all personnel that will be responsible for the operations.
→ Detailed Policies and Procedures
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.
→ If the site is an IV room, USP 797 compliance information
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.).
→ 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)
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.);
d. other (lockboxes, cages, gates, safe, etc.).
***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.
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:
Professional Licensing Agency
402 W Washington Street, Room W072
Indianapolis, IN 46204.