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US Pharm. 2009;34(5):36-38.
The FDA amended its action of warning manufacturers to stop production and distribution of certain unapproved prescription opioids. It will now allow, on an interim basis, the continued marketing and distribution of a high-concentration morphine sulfate oral solution, a product that is widely used to alleviate pain in terminally ill patients. Based on responses from concerned patients and health care professionals in the palliative care community, the agency determined that 20 mg/mL morphine sulfate oral solution was medically necessary and should remain on the market until an approved alternative becomes available. The FDA's decision only affects high-concentrate morphine sulfate solution and not the other unapproved prescription opioids mentioned in a March 30th warning letter sent to manufacturers. These include unapproved immediate-release tablets containing morphine sulfate, hydromorphone, and oxycodone that have not met the FDA's standards for safety, efficacy, and quality.
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U.S. Pharmacist is a monthly journal dedicated to providing the nation's pharmacists with up-to-date,
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