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Regulatory and Washington

  • CHPA responds to Food and Drug Administration’s APAP recommendation

    WASHINGTON — The Consumer Healthcare Products Association on Thursday responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

  • NCPA places support behind Diabetic Testing Supply Access Act

    ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday expressed its support behind the Diabetic Testing Supply Access Act (S. 1935). 

    The legislation would allow independent community pharmacies to provide same-day delivery of diabetes testing supplies to Medicare beneficiaries and was introduced by Senss Jerry Moran, R-Kan., and John Thune, R-S.D. 

    Since July 1, 2013 community pharmacies have been banned from delivering DTS to beneficiaries, including those who are homebound or in long-term care or assisted living facilities. 

  • House restores $85 million in FDA sequestered user fees

    WASHINGTON — The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

  • SIUE professor nabs U.S. patent

    EDWARDSVILLE, Ill. — Dr. Ronald Worthington, associate professor of pharmaceutical sciences at the School of Pharmacy at Southern Illinois University Edwardsville, obtained U.S. Patent No. 8,563,293 for his invention to protect against bacterial contamination. 

  • FDA warns of flammability of cryogenic wart removers

    SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued a warning that some cryogenic wart removers — which remove warts from the skin by freezing them off — have caught fire during use at home, harming consumers or setting fire to items around the house.

    Since 2009, FDA has received 14 such reports about over-the-counter wart remover products. Ten patients have described singed hair, blisters, burns or skin redness, the agency stated.

  • NAD refers ad claims made by Coorga Nutraceuticals for its Grey Defense dietary supplements to FTC

    NEW YORK — The National Advertising Division on Tuesday referred advertising claims made by Coorga Nutraceuticals Corp. for its Grey Defense dietary supplements to the Federal Trade Commission.

    NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

  • FDA recommends health professionals prescribe no more than 325 mg of acetaminophen per dose

    SILVER SPRING, Md. — The Food and Drug Administration on Tuesday recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit. 

  • FDA issues final guidance distinguishing liquid dietary supplements from beverages

    SILVER SPRING, Md. — The Food and Drug Administration earlier this week issued final guidance for the industry on distinguishing liquid dietary supplements from beverages. "We are issuing this guidance to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage," the agency stated.

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