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:

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.

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:

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: