Data Collection and Reporting Obligations
The Information Sharing Network collects pharmacy and complaint data relating to compounding activities through NABP e-Profile Connect. General pharmacy information will be entered by the pharmacy or the board, and complaint information will be entered by the board.
By signing the MOU and participating in the project, boards of pharmacy are obligated to report the following to FDA:
- Pharmacies that are compounding human drug products and distributing inordinate amounts interstate, as well as their compounding data.
- Complaints of serious adverse experiences or quality issues relating to human drug products compounded by pharmacies and distributed interstate.
- Complaints of adverse experiences or quality issues relating to human drug products compounded by a physician and distributed interstate.
- Information relating to the distribution interstate of any amount of human drug products compounded by physicians.
What data is collected through the network?
Compounding Pharmacy Information
The following information will be collected from participating pharmacies that distribute or dispense compounded human drug products:
- Name and address of state-licensed entity
- Whether the pharmacy participates in the following activities during an identified calendar year:
- Human drug compounding – sterile
- Human drug compounding – nonsterile
- Patient-specific compounding
- Non-patient-specific compounding
If a pharmacy is compounding sterile or nonsterile human drug products, the following information will also be collected or calculated for the identified calendar year.
- Number of prescription orders for compounded human drugs the pharmacy sent out of the facility
- Number of prescription orders for compounded human drugs dispensed at the facility
- Total number of prescription orders for compounded human drugs sent out of or dispensed at the facility (calculated by the system)
- Total number of prescription orders for compounded human drugs distributed interstate
- Percentage of compounded human drugs distributed interstate (calculated by the system)
- Number of prescription orders for sterile compounded human drugs distributed interstate
- Names of states in which the pharmacy is licensed
- Names of states into which the pharmacy distributed compounded human drugs during the year
- Whether compounded human drugs are distributed without patient-specific prescriptions
Complaints about Compounding Pharmacies
The following information will be collected from boards regarding complaints involving a serious adverse drug experience or serious product quality issue related to compounded human drug products that are distributed interstate:
- Name and contact information of the complainant, if available
- Name and address of the pharmacy that is the subject of the complaint
- Description of the complaint, including a description of any compounded human drug product that is the subject of the complaint
- The board’s assessment of whether the complaint was substantiated, if available
- Description of any actions the board has taken to address the complaint
Complaints or Notifications about Compounding Physicians
The following information will be collected from boards regarding complaints involving an adverse drug experience or product quality issue related to human drug products compounded by a physician or regarding notifications of the distribution of any amount of human drug products compounded by a physician, and distributed interstate:
- Name and contact information of the complainant or notifier
- Name and address of the physician who is the subject of the complaint or notification
- A description of the complaint or notification, including a description of any compounded human drug product that is the subject of the complaint or notification