MELBOURNE, Fla. (PRWEB) July 02, 2019
As such, AmEx Pharmacy ensures our sterile injections are produced in a certified cleanroom and laminar air-flow work space in order to maintain asepsis, thus ensuring a sterile end product that is provided to health care professionals. Each container/closure syringe is vetted and tested to ensure the drug remains sterile throughout the beyond-use date. Additionally, AmEx Pharmacy conducts mandatory release testing on all Batches of sterile products produced in our cleanroom environment. The following destructive chemical testing is conducted on each Batch of product intended to be sterile:
- Sterility per USP 71
- Endotoxin per USP 85
- Subvisible Particulate Matter per USP 787
Furthermore, AmEx Pharmacy conducts 100% visual inspections on each Batch of sterile product by a licensed pharmacist. These quality attributes include:
- Verification of color and clarity of the product
- Verification that no bubble is present in the syringe
- Verification that there is no presence of visible particulates
- Verification of dosage
Should any of the aforementioned testing fail, AmEx Pharmacy quarantines said products, conducts an investigation, and subsequently dispositions the product per internal procedures. Once a Batch of sterile product produced by AmEx Pharmacy meets all stringent quality standards, the product is released for distribution into the supply chain for subsequent use in an office setting.
Since registering with the FDA as a 503B Outsourcing Facility in 2016, AmEx Pharmacy has not received sterility failure results of a Batch of product intended to indeed be sterile. Furthermore, AmEx Pharmacy has not received reports of adverse drug events related to product sterility issues. To ensure transparency, AmEx Pharmacy is committed to providing a Certificate of Analysis for any Batch of sterile drug product produced by our trained sterile compounding technicians which outlines specific testing (and results) applicable to that product.
Adverse reactions or quality problems experienced with the use of AmEx Pharmacy product may be reported directly to us, or to the FDA’s Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form at http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Lastly, AmEx Pharmacy invites health care professionals to engage in dialogue with the AmEx Pharmacy team. Health care professionals or consumers with questions regarding this press release can contact AmEx Pharmacy at (800) 644 – 9431 or by email at pharmacist@amexpharmacy.com during normal business hours Monday through Friday 9:00a.m. – 6:00p.m, EST.