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U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House Bill
…to practice pharmacy and dispense prescription drugs in Canada; (3) is purchased for personal use by the individual, not for resale, in quantities that do not exceed a 90-day supply;…
Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning
…[are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov. A short-form warning for the same product could read: ⚠WARNING: Cancer – www.P65Warnings.ca.gov Not…
Tuesdays (and Thursdays) With Regulations.gov BETA
Anyone who has recently (on Tuesdays and Thursdays at least) tried – and we mean tried – to wander on to www.regulations.gov to do a little FDA docket research has…
FDA Sets Enforcement Date for Restaurant Menu (and Coupon!) Labeling
…the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also…
DDMAC Digs Deep to Link Unbranded Websites to Violative Promotional Practices
By Carrie S. Martin – FDA just released the Warning Letter it issued to Novartis Pharmaceuticals Corporation (“Novartis”) in April regarding two purportedly unbranded websites, www.gistalliance.com and www.cmlalliance.com (the “alliance…
FDA Amends Informed Consent Regulations
…the trial has been or will be entered into a databank accessible to the public via www.clinicaltrials.gov. FDA published the proposed rule implementing the FDAAA requirement in December 2009, and…
Pharmacists Associations Petition FDA to Utilize Enforcement Discretion as July 1 Deadline for Product-Tracing Compliance Nears
By Andrew J. Hull* – On June 22, three major pharmacists associations signed a letter to FDA asking the agency to use its enforcement discretion as pharmacies struggle to create…
SCOTUS Makes it Easier for Government to Withhold Commercial or Financial Information
…privileged or confidential.” 5 U.S.C. 552(b)(4). In this case, a South Dakota newspaper (Argus Leader) filed a FOIA request with the U.S. Department of Agriculture (USDA) for data related to…
Hyman, Phelps & McNamara, P.C. Calls On FDA to Post on the Internet All Court Filings Regarding Enforcement Actions
…downloadable, and searchable online.” On March 11, 2011, this firm sent a letter to the FDA Chief Counsel, Ralph S. Tyler, calling on FDA to commit to posting on its…
Further Musings about DEA’s “Suspicious Order” Proposed Rule: What Will a Registrant be Required to Report?
…PDDA to make this portal available). Importantly, SORS Online established more than just an online reporting method because DEA also for the first time required registrants to provide a “reason…
As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows
…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…
The Canadian Drug Importation Rule Survives Industry Challenge, But Don’t Expect Canadian Drugs at Your Pharmacy Just Yet
…of harm. Despite the apparent green light, it will be a while before we see Canadian drugs on our pharmacy shelves. The final rule does not itself permit any drugs…
Not An April Fool’s Joke: California BOP Establishes Loss Reporting Thresholds
…it “significant” relative to how much the pharmacy dispenses. So even if losses do not hit a threshold, a pharmacy must report a loss deemed significant. We wonder how often…
OIG Proposed Safe Harbor Revisions Take Aim at Formulary Rebates, Volume-Based PBM Administrative Fees
…chargeback or rebate to the pharmacy if the full price reduction to the pharmacy, combined with the patient’s cost sharing and the plan’s reimbursement to the pharmacy, is at least…
Pharmacy Compounding and Outsourcing Facilities: What Inquiring Minds Want to Know….
…Hyman, Phelps & McNamara, P.C.’s compounding expert and blogger Karla Palmer, presenting on “Pharmacy Compounding Regulation: Deconstructing Latest Guidance, Compliance & Enforcement Activities.” The webinar will occur on Tuesday, October…