Infectious Disease

Avoid using certain Greenpark Compounding Pharmacy products

17.09.2021

Read for 2 minutes

ADD SUBJECT TO EMAIL ALERTS

Receive an email when new articles are published on

Please enter your email address to receive an email when new articles are published on . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If this problem persists, please contact customerservice@slackinc.com.

Back to Healio

The FDA recommended that health care providers and individuals avoid compound products labeled “sterile, manufactured and used nationwide by Prescription Labs Inc.” that does business as Greenpark Compounding Pharmacy.

The agency justified its recommendation with a lack of “sterility assurance”. It also said inspections of Greenpark Compounding Pharmacy operations raise several concerns, including having employees wearing non-sterile equipment, manufacturing non-sterile drugs in non-sterile areas, and failing to recertify airflow and quality at some of their business locations.

Photo source: Adobe Stock

The FDA also announced that Greenpark Compounding Pharmacy began recalling multiple lots of a compound eye medicine in August. The following month, the agency recommended that the recall also include “any unexpired compound drug that is intended to be sterile and should cease sterile production pending appropriate corrective action”. The company “has refused to recall any unexpired compound drugs that are said to be sterile or to stop manufacturing all sterile drugs,” the FDA stated.

The FDA added that it was not aware of any drug-related adverse events from Greenpark Compounding Pharmacy. The agency also said customers who have concerns about this announcement should speak to their doctor. In addition, individuals who experience adverse events or quality issues related to Greenpark Compounding Pharmacy’s products should file a report with the MedWatch Adverse Event Reporting Program of the FDA.

Houston-based Greenpark Compounding Pharmacy makes pain management and hormone therapy drugs, as well as drugs in the fields of pediatrics, dermatology, podiatry, and sports medicine, according to the company’s website.

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

“The FDA has federal powers to apply national drug company practices to state-regulated pharmacies,” added Hughes.

References:

FDA. The FDA warns patients and healthcare professionals not to use compound products designed 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 September 17, 2021.

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

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

ADD SUBJECT TO EMAIL ALERTS

Receive an email when new articles are published on

Please enter your email address to receive an email when new articles are published on . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If this problem persists, please contact customerservice@slackinc.com.

Back to Healio

Related Articles