Summary of FDA Guidance for Industry:
Pharmaceutical Components Risk for Melamine Contamination
Authored by: Ryan White
In August 2009, the U.S. Food and Drug Administration (FDA) issued an industry guidance document titled Pharmaceutical Components Risk for Melamine Contamination. The guidance was issued to alert pharmaceutical manufacturers to the potential risk of melamine contamination in pharmaceutical components. At issuance, the FDA was unaware of any pharmaceuticals that had been contaminated with melamine.
In 2007, there was a spate of cat and dog illnesses and deaths due to melamine contamination in vegetable proteins imported to the U.S. from China used in certain pet and livestock food products. Likewise, in September 2008, the FDA received reports of infant formula in China being contaminated with melamine. The FDA has indicated that similarly derived pharmaceutical components are also at risk for being contaminated with melamine.
Melamine is a nitrogen based compound that was utilized to bolster the apparent protein content in foods or ingredients used in processed food products intended to contain protein.
The FDA guidance document provides recommendations to assist pharmaceutical manufacturers to better control the use of potential melamine contaminated materials. The guidance identifies and lists some of the materials that are at-risk for melamine contamination (Figure 1), as well as outlines recommendations that pharmaceutical manufacturers should take when working with those at-risk components.
Figure 1: Non exhaustive list of components that need test for melamine contamination from the formulary (USP/NF) monographs and the FDA Inactive Ingredient Database (IID).
|
Adenine (USP) |
Glucagon (USP) |
|
Albumin (IID)8 |
Guar gum (USP/NF) |
|
Amino acids derived from casein protein hydrolysates8 |
Hyaluronidase (USP)8 |
|
Ammonium salts9 |
Imidurea (USP/NF) |
|
Calcium pantothenate (USP) |
Lactose (USP/NF, IID)10 |
|
Caseinate or sodium caseinate (IID)8,10 |
Melphalan (USP) |
|
Chlorophyllin copper complex sodium (USP) |
Povidone (USP/NF) |
|
Colloidal oatmeal (USP) |
Povidone-Iodine (USP) |
|
Copovidone (USP/NF) |
Protamine sulfate (USP) |
|
Crospovidone (USP/NF) |
Protein hydrolysate (powder) for injection (USP) |
|
Dihydroxyaluminum aminoacetate(USP) |
Taurine (USP) |
|
Gelatin (IID)8 |
The guidance recommends testing for melamine contamination prior to releasing to manufacturing as well as, identifying the at-risk component manufacturers and obtaining certification from those manufacturers that the materials were tested for melamine contamination prior to release.
For more information and to read the FDA guidance document, go to http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM175984.pdf