FDA throws support behind compounding pharmacies in response to potential drug shortages

In a move that will have ramifications in Australia and around the world, the U.S. government’s Federal Drug Administration (FDA) is introducing changes which may significantly reduce the number and duration of pharmaceutical drug shortages.

Matthew Bellgrove, Director of National Custom Compounding on the Gold Coast welcomed the changes, which will remove some of the ‘regulatory burden’ from compounding pharmacies, saying Australia should consider a similar move.

“It’s about future-proofing the medical industry against disruptions to medicine production,” Mr Bellgrove said, “In Australia our Therapeutic Goods Administration (TGA) regularly issues alerts listing medicines that are currently unavailable in the country. Tamiflu is a good example – we regularly run out of this important medication.”

“You only have to look at the recent hurricane in Puerto Rico that brought the island’s huge pharmaceutical industry to a grinding halt, to realise the issue of future drug shortages is very real,” Mr Bellgrove said, “The Puerto Rican industry supplies an estimated 10 per cent of the America’s pharmaceuticals and some of these drugs are not manufactured anywhere else in the world.”

“The U.S. Government heavily invested money and resources to help the Puerto Rican industry rebuild and get back to operations quickly. We avoided any long-term drug-shortages but it gave them a scare. Next time we may not be so lucky.”

Mr Bellgrove said he was hopeful Australia would follow America’s lead by encouraging  compounding pharmacies to sure up their operations in readiness to fill a need should it come in the future.

“The FDA is doing the sensible thing and swiftly introducing a back-up plan by encouraging compounding pharmacies to improve their services,” Mr Bellgrove said, “A similar program in Australia could provide some security for our own medical sector and reduce the risk associated with reliance on overseas supply.”

Compounding pharmacies essentially make medications ‘from scratch’, in regulated laboratories, using the same highly-controlled active ingredients found in commercial medications. Compounding pharmacies are often called on to re-create drugs for patients sensitive to preservatives and dyes and also to make up medications that have become unavailable through the usual channels due to high demand or discontinued manufacture.

FDA Commissioner Scott Gottlieb said his administration was looking to bolster the number of compounding pharmacies registering to become official ‘outsourcing facilities’. These facilities would be called on to manufacture pharmaceuticals during times of commercial shortages.

In a statement issued in late September, Mr Gottlieb said, “Appropriately compounded drugs can provide important alternatives for patients who need them. Our ultimate goal is to make it more feasible for compounding pharmacies to register as outsourcing facilities, enabling them to grow their businesses under a legally approved framework, and increase access to better quality compounded drugs in the process.”

Mr Bellgrove said any changes to U.S. drug manufacturing guidelines would be watched closely by the Therapeutic Goods Administration, Australia’s counterpart of the FDA.

“The United States is home to most of the big pharmaceutical companies, supplying a significant percentage of the world’s medications. Changes to the pharmaceutical industry over there will impact us here on the other side of the Pacific,” Mr Bellgrove said.

“We look forward to learning the finer detail of the FDA’s new regulations on compounding when they’re released in the coming months.”

This article first appeared in the Australian Journal of Pharmacy. 13 November 2017.