FDA: Keep away from utilizing sure Greenpark Compounding Pharmacy merchandise
http://mymedicaldaily.com/fda-avoid-using-certain-greenpark-compounding-pharmacy-products-2/
The FDA advisable well being care suppliers and people keep away from using compounded products mentioned to be “sterile, produced and distributed nationwide by Prescription Labs Inc.” that does enterprise as Greenpark Compounding Pharmacy.
The company primarily based its advice on an absence of “sterility assurance.” It additionally mentioned inspections of Greenpark Compounding Pharmacy operations raised a number of considerations, together with workers carrying nonsterile gear, producing nonsterile medication in nonsterile areas and failing to have the airflow and air high quality at a few of its enterprise places recertified.
The FDA additionally acknowledged Greenpark Compounding Pharmacy started recalling a number of plenty of a compounded ophthalmic drug in August. The next month, the company advisable the recall additionally embrace “all unexpired compounded medication meant to be sterile and cease sterile manufacturing till it implements ample corrective actions.” The corporate “has refused to recall all unexpired compounded drug merchandise meant to be sterile or to stop compounding of all sterile medication,” the FDA acknowledged.
The FDA added it isn’t conscious of any hostile occasions tied to medication from Greenpark Compounding Pharmacy. The company additionally mentioned that clients with considerations associated to this announcement ought to attain out to their well being care skilled. As well as, those that expertise hostile occasions or high quality points tied to Greenpark Compounding Pharmacy’s merchandise ought to file a report with the FDA’s MedWatch Hostile Occasion Reporting program.
Primarily based in Houston, Greenpark Compounding Pharmacy compounds medicines used for treating ache and for hormone remedy, in addition to medicines used within the pediatric, dermatology, podiatry and sports activities medication fields, based on the corporate’s web site.
In response to the FDA’s claims, Kenneth Hughes, RPh, a compounding pharmacist with Greenpark Compounding Pharmacy, advised Healio Main Care the corporate is “in good standing” with Texas’ Board of Pharmacy. Hughes additionally famous that the corporate follows all of the state board’s laws and “supplies secure sterile and nonsterile medicines for Texas.”
“The FDA is exerting its federal authority to use nationwide pharmaceutical firm practices to state-regulated pharmacies,” Hughes added.
References:
FDA. FDA alerts sufferers and well being care professionals to not use compounded merchandise meant 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. A number of paperwork pertaining to Greenpark Compounding Pharmacy. https://www.fda.gov/media/152236/download. Accessed Sept. 17, 2021.
Greenpark Compounding Pharmacy. Residence web page. https://greenparkrx.com/index.php. Accessed Sept. 17, 2021.
Filed under: General Problems
Dr. Steve, DO compounding pharmacies often make “sterile” preparations? That would seem to me to require extra equipment and time.
I believe that most pain clinics that are doing implanted pumps… are using compounding pharmacy… the only commercially available opiate for pumps is Infumorph ( Morphine)… Any pt that has meds put in their pump that has more than just Morphine in their pump… it being obtained from a compounding pharmacy… and BTW… the FDA does not recommend that pharmacy compounded meds BE USED IN IMPLANTED PUMPS. I have been told that pain clinics use these compounding pharmacies because they can purchase the meds at 10%-25% of the cost of Infumorph… and the way that those meds are billed they are using HCPCS Codes… which are very vague type of billing… they are essentially billing Infumorph and getting reimbursed at the allowable rate for Infumorph. It is not the same billing process ( using NDC numbers) that pharmacies use to bill insurance for meds. Here is worse case of non-sterile to sterile compounding GOING BAD…https://en.wikipedia.org/wiki/New_England_Compounding_Center_meningitis_outbreak Non-sterile to sterile compounding is classified as “high risk compounding”. Back in the 80’s I got certified in sterile add-mixtures – where you combine two or more commercially sterile products – using aseptic techniques – to produce a final product. I never had any interest in doing non-sterile to sterile compounding.
Thank you.