Lot distributed by Downing Labs is first placed into quarantine for 14 days, until certification from our FDA registered third party testing facility has confirmed the product is sterile and also meets required endotoxin levels. If there is ever any question regarding a lot that has been distributed, please contact any of our staff and we will provide the testing certificate for you within 1 business day.
Downing Labs, LLC is a retail and compounding pharmacy 100% committed to patient safety. We currently adhere to the USP <71> sterility standards. This involves meeting all requirements when submitting sampling, which also includes method suitability.
We follow all state pharmacy laws and our pharmacy license is in good standing with the Texas State Board of Pharmacy. Under our current agreement with FDA, Downing Labs subjects themselves to a quarterly audit by a Drug Expert in both our sterile and non-sterile lab. These audits are sent to FDA and the licensed State Board of Pharmacy to ensure compliance. Any audit finding by the Drug Expert or Regulatory, will be corrected within 30 days and submitted to FDA. Downing labs operates under FDA jurisdiction to ensure patient safety above required standards.