FDA calls for melamine screening in pharmaceuticals

Lab equipment 1The US Food and Drug Administration is advising pharmaceutical companies to test certain ingredients for melamine, a toxic chemical that caused a major public health scandal last year when it was encountered in infant formula and various milk-based food products.

Melamine is a synthetic compound used in resins, cleaning products and other industrial chemicals and if ingested in sufficient quantities can cause kidney failure and death. 

In 2008, infant formula contaminated with melamine caused around 50,000 infants in China to become ill, and led to an estimated six deaths.

Appallingly, it is suspected that the contamination of milk-based ingredients that went into the formula could have been deliberate and designed to fool analytical tests for protein levels based on nitrogen content.

Three officials from the Chinese company that made the formula were eventually sentenced to death or life imprisonment.

“Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the USA, and milk products for infants in China, underscore the potential problem,” said the agency in a statement.

The guidance document (available here) is intended to help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding to avoid the use of components that are at risk for melamine contamination.

The document asks manufacturers of medicines to carry out a risk-assessment to see if any of their ingredients could be susceptible to melamine contamination, and if that is the case recommends testing for melamine before the components are released for use in the manufacture or preparation of drug products.

Drugmakers should also maintain tight oversight of their supply chain and obtain certification from component manufacturers that their material is tested for contamination.

The following ingredients are considered at-risk for melamine contamination, says the FDA, which emphasises that the list is not exhaustive:

  • adenine
  • albumin
  • amino acids derived from casein protein hydrolysates
  • ammonium salts
  • calcium pantothenate
  • caseinate or sodium caseinate
  • chlorophyllin copper complex sodium
  • colloidal oatmeal
  • copovidone
  • crospovidone
  • dihydroxyaluminum aminoacetate
  • gelatin
  • glucagon
  • guar gum
  • hyaluronidase
  • imidurea
  • lactose
  • melphalan
  • povidone
  • povidone-iodine
  • protamine sulfate
  • protein hydrolysate (powder) for injection
  • taurine
  • thioguanine
  • urea
  • wheat bran
  • zein

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said FDA Commissioner Peggy Hamburg.

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