The U.S. Food and Drug Administration is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy, in Melbourne, Florida. The drugs—which include compounded ophthalmic products among other drug products — pose unnecessary risks due to significant quality and sterility concerns.
“When the FDA becomes aware of drugs that have the potential to cause harm to American consumers, we will alert the public, Prior to today’s outreach, AmEx Pharmacy refused to recall all sterile drug products and has not adequately addressed FDA’s concern that it is manufacturing drugs that are not in line with the quality standards we’ve set, putting patients at risk,” said Acting FDA Commissioner Ned Sharpless, M.D. “We urge drug manufacturers and compounders to take appropriate action to ensure quality medicines as the agency continues our efforts to protect public health.”
An FDA inspection of AmEx Pharmacy’s facility found conditions that could cause the company’s drugs to become contaminated or otherwise pose risks to patients. As a result, the agency recommended on June 25that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations until the company takes adequate corrective actions. However, AmEx Pharmacy declined to initiate a recall of all unexpired drugs intended to be sterile and has not provided adequate assurances regarding the sterility and quality of its remaining and newly manufactured products.
Because of this, the agency today issued a formal request to the outsourcing facility to recall all non-expired lots of drugs intended to be sterile. The FDA is also urging consumers to stop using these drugs and dispose of them immediately. Additionally, the agency is requesting the outsourcing facility cease production of drugs intended to be sterile until adequate remediation actions have been taken.
Administration of a non-sterile drug intended to be sterile presents the risk of infection. Intraocular medications which are not sterile can lead to intraocular infections such as endophthalmitis which, depending on the infecting microorganism, can lead to a loss of partial or total permanent visual function (i.e., no light perception). Patients who have concerns about receiving any drug produced by AmEx Pharmacy or who observe signs of an infection after using these medicines should contact their health care professional.
Health care professionals should immediately check their medical supplies, quarantine any drugs intended to be sterile and prepared by AmEx Pharmacy, and not administer or provide them to patients. The FDA urges health care professionals who obtained drugs from AmEx Pharmacy to make alternative arrangements to obtain medications from sources that adhere to proper quality standards.
“Although compounded drugs can serve an important need for some patients, they present a higher risk because they do not undergo premarket review to ensure that they are safe and effective for their intended use and to verify their manufacturing quality,” said Donald D. Ashley, director of compliance for the FDA’s Center for Drug Evaluation and Research. “The agency’s compounding program aims to protect patients from unsafe, ineffective and poor-quality compounded drugs, while preserving access to compounded drugs for patients for whom an FDA-approved drug is not medically appropriate.”
The FDA has received reports of adverse events associated with the use of AmEx Pharmacy’s drugs. The FDA encourages health care professionals and consumers to report adverse events to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
AmEx Pharmacy is registered as an outsourcing facility under section 503B of the Federal Food, Drug and Cosmetic Act. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section 503B to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility.