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Why a Drug Went on Shortage


April 01, 2016

 

QOL Medical is experiencing a shortage of sacrosidase (Sucraid), 8,500 I.U./mL 118 mL per bottle, 2 bottles/pack (NDC 67871-111-04).

Why is the product currently unavailable? The company indicated that the process for making the active pharmaceutical ingredient (API) doesn’t meet the required good manufacturing practices.

Unfortunately, there has been a delay with the conversion to the updated process, the company noted.

In July 2015, Pharmacy Learning Network reported that the company had announced that there would be a shortage from July to October due to the API being unavailable. In order to mitigate the shortage, the company made Sucraid lot #A1147 available, a product that was made in a non-FDA approved facility.

Physicians prescribing the Sucraid lot in question and patients taking it must fill out forms acknowledging that the product doesn’t meet FDA standards.

What does signing mean? Patients and physicians are acknowledging the potential risk that the drug may contain bacterial byproducts due to the manufacturing process, which could raise safety concerns. The acknowledgment form notes that immunocompromised patients are at risk.

Click here for more information regarding this shortage.

 

--Stephanie Vaccaro

 

References:

1. U.S. Food and Drug Administration. FDA drug shortages. www.fda.gov. Accessed April 1, 2016.

 

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