FDA: Avoid using certain Greenpark Compounding Pharmacy products

The FDA recommended health care providers and individuals avoid using compounded products said to be “sterile, produced and distributed nationwide by Prescription Labs Inc.” that does business as Greenpark Compounding Pharmacy.

The agency based its recommendation on a lack of “sterility assurance.” It also said inspections of Greenpark Compounding Pharmacy operations raised several concerns, including employees wearing nonsterile gear, producing nonsterile drugs in nonsterile areas and failing to have the airflow and air quality at some of its business locations recertified.

The FDA also stated Greenpark Compounding Pharmacy began recalling several lots of a compounded ophthalmic drug in August. The following month, the agency recommended the recall also include “all unexpired compounded drugs intended to be sterile and stop sterile production until it implements adequate corrective actions.” The company “has refused to recall all unexpired compounded drug products intended to be sterile or to cease compounding of all sterile drugs,” the FDA stated.

The FDA added it is not aware of any adverse events tied to drugs from Greenpark Compounding Pharmacy. The agency also said that customers with concerns related to this announcement should reach out to their health care professional. In addition, those who experience adverse events or quality issues tied to Greenpark Compounding Pharmacy’s products should file a report with the FDA’s MedWatch Adverse Event Reporting program.

Based in Houston, Greenpark Compounding Pharmacy compounds medications used for treating pain and for hormone therapy, as well as medications used in the pediatric, dermatology, podiatry and sports medicine fields, according to the company’s website.

In response to the FDA’s claims, Kenneth Hughes, RPh, a compounding pharmacist with Greenpark Compounding Pharmacy, told Healio Primary Care the company is “in good standing” with Texas’ Board of Pharmacy. Hughes also noted that the company follows all the state board’s regulations and “provides safe sterile and nonsterile medications for Texas.”

“The FDA is exerting its federal authority to apply national pharmaceutical company practices to state-regulated pharmacies,” Hughes added.

References:

FDA. FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-not-use-compounded-products-intended-be-sterile?utm_medium=email&utm_source=govdelivery. Accessed Sept. 17, 2021.

FDA. Several documents pertaining to Greenpark Compounding Pharmacy. https://www.fda.gov/media/152236/download. Accessed Sept. 17, 2021.

Greenpark Compounding Pharmacy. Home page. https://greenparkrx.com/index.php. Accessed Sept. 17, 2021.