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The US Pharmacopeia has approved new testing guidelines for sterile pharmaceutical products. Injected and implanted products must be free from bacterial endotoxins, which can cause inflammation. Widely used current tests rely on reagents extracted from wild horseshoe crabs, a practice that environmentalists say strains ecosystems. Synthetic alternatives have been approved in several countries, but US drug makers have been reluctant to change testing processes without a regulatory green light. The new guidelines will take effect in May 2025.
Laurel Oldach (Mon,) studied this question.