AIS requires the following items to be completed before conducting the inspection:
The AIS Inspection Application must be completed and submitted. You will be able to choose all states for which a report is needed.
Contract and Business Associate Agreement (BAA)
After the completed application is received, the Account Advisor will send a contract and Business Associate Agreement. These must be completed and returned to your assigned Account Advisor.
Payment must be made in full by check or credit card. Fees include:
INSPECTION FEE: The fee for a one-day inspection is $2,995. This fee includes all Inspector travel, meal, and lodging expenses.
LABORATORY TESTING FOR TEXAS STATE BOARD OF PHARMACY (TSBP) CLASS E-S LICENSE: (This applies only to pharmacies seeking approval from the TSBP to ship into TX). TSBP requires the Inspector to collect a sample of a compounded medication for potency, sterility, endotoxin and fungal testing. The pharmacy is responsible for covering the cost of testing, packaging, and overnight shipping of the sample to the laboratory up front. AIS estimates the cost to perform the tests will be about $800. In certain cases, the cost may be as high as $1,500. In these cases, the pharmacy will be notified and required to cover any additional expense.
In order to qualify for inspection, pharmacies must have been providing compounding services for a minimum of 30 days. The on-site inspection will occur within 60 days of AIS receiving the completed contract and payment. The inspection is unannounced, and will occur within a two-week time frame that will be identified by AIS. The actual date of the inspection will not be provided.
AIS inspects compounding pharmacies according to state requirements. Please note that in cases where USP standards and state requirements differ, state requirements supersede USP <795> and <797>.
AIS will provide the inspection report to state boards of pharmacy within 10 business days of inspection. AIS does not make licensure determinations. AIS's role is to collect information on behalf of state regulatory bodies.