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…agency had not yet completed its review of the provisions in the CARES Act that affect FDA’s regulation of OTC drugs, and, therefore, officials could not comment on the specific…
…CSA. 21 U.S.C. § 830(e)(1)(A)(vii); 21 C.F.R. §§ 1314.35-.42, 1314.101-.103. Regardless, the Act’s requirements will make practitioners more carefully consider issuing a first opioid prescription for longer than seven days….
…of $12,000,000 for pharmacy compounding activities specified in the Drug Quality and Security Act (DQSA). The Committee urges FDA to complete inspections of compounding facilities that clearly fall within the…
…reportedly been introduced in the U.S. House of Representatives. According to a press release from the U.S. Senate Special Committee on Aging, the bill is intended “to provide doctors with…
…prescriptions — whether paper or electronic — between pharmacies for the initial filling of the prescription. Historically, if a patient presented a paper prescription to a pharmacy and the pharmacy…
…will not only encounter continued physician resistance to prescription verification, but also find it even more difficult to comply with their corresponding responsibility to ensure that the prescriptions they fill…
…has been available by prescription since 1999. On August 24, 2006, FDA approved non-prescription use of Plan B for women 18 years and older. Women 17 years and younger, however,…
…origins back to at least October 2009 when Senator Kohl, who is Chairman of the Special Committee on Aging and a Member of the Judiciary and Appropriations Committees, corresponded with…
…the EPCS prescription record to note the transfer. That pharmacist must also update the prescription record with: Name, address, and DEA registration number of the pharmacy to which the prescription…
…180-day, real-time or panel track supplement to FDA; and For Health Canada, specify if it represents a new or significant change amendment Class III or IV submission to Health Canada….
…process, has “stringent standards” against the issuance of prescriptions based on online consultations, and does not certify Canadian online pharmacies. Google also hired a third-party company to detect pharmacy advertisers’…
…2019, Florida became the second state to pass a bill allowing for the importation of prescription drugs from Canada. (In May 2018, Vermont became the first state to pass this…
Last November, we explained FDA’s role in blocking over-the-counter (OTC) rapid antigen tests from the American market. We identified as the main culprit FDA’s requirement that these tests achieve 80%…
…proposed in 21 C.F.R. Part 343 but are not part of 21 CFR part 201; (6) acetaminophen-narcotic combinations; and (7) prescription labeling for OTC IAAA drug products. FDA will, however,…
…requesting that FDA determine that any company with a pending Abbreviated New Drug Application (“ANDA”) for a proposed Venlafaxine HCl Extended-Release Tablets drug product, and in particular Sun Pharmaceutical Industries…