Navigating Through State Compliance

Compliance: States Navigation – Step by Step

Pharmaceutical compliance refers to adherence to all applicable laws, regulations, and ethical standards governing the development, manufacturing, dispensing, and distribution of drugs. This includes ensuring product safety, efficacy, quality, and maintaining transparency and accountability throughout all pharmacy operations.

---

Accessing State Compliance

1. Click the FileMaker Pro icon to open FileMaker.
2. When FileMaker opens, locate the menu bar on the left.
3. Click SiCompounding (near the top).
4. From the center icons, click Pharmacy to open the Dashboard.
5. From the blue sidebar menu, click Compliance.

---

Compliance Main Menu

At the top of the Compliance module, the Main Menu includes:

• Reports
  See linked guide: What Reports are Included in Compliance?
• General Features
  • Search
  • Lookup
  • < Go Back
  • Help
  • Notifications (Bell Icon)
    See linked guide: General Features of SiCompounding

---

State Authorization Map

A U.S. Map displays State authorization status using color indicators:

• Authorized with CS – Controlled Substances permitted
• Do Not Dispense CS – Controlled Substances restricted
• Not Authorized – State not yet authorized

Licenses Expiring Soon

• Enter a date in Expire Before (calendar icon)
• Displays licenses expiring on or before the selected date

---

States and Licenses

States Widget

1. Under States and Licenses, click the States widget.
2. The States window opens, where all State-related data is managed.
3. Use the Search bar to locate a State by name.

---

State Overview Statistics

After selecting a State, the following dynamic buttons appear above the main menu:

• Patients – Opens State-related patients
• Providers – Opens State-related providers
• Total Rx – Opens prescriptions for the State
• Total CS Rx – Opens controlled substance prescriptions
• Dispenses – Opens State-related dispense records

Use the < Go Back button to return after viewing each section.

---

State Profile (Default Tab)

Click Edit to open the State Information Form.

Dispense Authority

• Dispense Authority (dropdown)
  • Authorized
  • Authorized with CS

---

State Settings

• USP 71 Compendial Enforced (Y | N)
• Require Delivery Signature (Y | N)
• State Surcharge
• Renewal Open (number of days)

---

Dispense Restrictions

Some States require:

• A Sterile Compounding License
• Restrictions on shipping Sterile / Non-Sterile products
• Storage condition validation during shipment

Follow all State Board of Pharmacy regulations when configuring these settings.

Authorized Storage Conditions

• ☐ Frozen
• ☐ Refrigerated
• ☐ Room Temperature

Authorized Product Types

• ☐ Non-Sterile
• ☐ Sterile

---

PMP Report Settings

• PMP ASAP Version (dropdown)
• Reporting Platform (dropdown)
• File Type (dropdown)
• Report Zero (Y | N)
• Report All Prescriptions (Y | N)
• PMP Report Exempt (Y | N)

PMP FTP Information

• FTP URL (IP or Hostname)
• Port
• Default Directory
• Authentication Type
• Username
• Password

PMP Website Information

• Report Website URL
• Username
• Password

---

License & Query Websites

• License Website
  • URL
  • Username
  • Password
• Query Website
  • URL
  • Username
  • Password

Click Save after completing all required fields.

---

Communication Notes

1. Click + Note to open a New Communication Form.
2. Select Document Type:
   • Email
   • Note
   • Phone Call
   • SMS
3. Enter note details.
4. Add supporting documents or images via Drag & Drop.
5. Click Save.

Communication Actions (Gear Icon)

• Print Note
• Fax as PDF
• Dismiss
  • Confirm using CONTINUE
  • Cancel using STOP

---

Licenses (State Tab)

Add License

1. Use the Search bar to locate licenses.
2. Click + License.
3. Enter:
   • State
   • Staff Name
   • License Type
   • License Number
   • Valid Until
   • Opening Renewal Date
   • Image (Drag & Drop)
4. Click Save.

License Actions

• Document (Preview)
• Edit
• Delete
• Access Logs
• Change Logs

---

License Costs

1. Click + License Cost.
2. Enter:
   • License Type
   • Cost
3. Click Save.

Actions:

• Edit
• Delete

---

Restricted Formulas (State Tab)

1. Use the Search bar to locate formulas.
2. Click + Formula.
3. Select formula from Master Formula list.
4. Filter by:
   • Active
   • Inactive
   • All
   • Status

Actions:

• Delete

---

Drugs of Interest (State Tab)

1. Use the Search bar by License Type.
2. Click + Drug of Interest.
3. Enter required data.
4. Click Save.

Actions:

• Delete

---

State Compliance (State Tab)

• Displays State Items of Concern
• Search by Drug Name
• E-RX Requirements for Controlled Substances
  (Feature under development)

---

Documents (State Tab)

1. Use the Search bar to locate documents.
2. Click + Document.
3. Drag & drop files.
4. Select document type and add description.
5. Click Save.

Actions:

• View Document
• Delete

---

Actions (State Tab)

• License Report – Prints State License Report
• Access Logs
• Change Logs
• Refresh Stats
  • Patients
  • Physicians
  • Total Rx
  • And more

---

Completion

This concludes the step-by-step guide for Navigating Through State Compliance in SiCompounding.