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    Trump Administration Takes a Turn at Medicare Part B Payment Reform

    …other developed economies (Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Japan, Portugal, Slovakia, Spain, Sweden, and United Kingdom). The HHS analysis found that, on average, the…

    Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled

    If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. However,…

    California to Pharmacies: Start Balancing your Opioid Checkbook

    …stored within the hospital pharmacy and for each of the pharmacy’s satellite locations. Id. § 1715.65(g). The PICs of pharmacies that service “automated drug delivery systems” such as Pyxis machines,…

    Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit

    …law may render those cases inconsequential in that state. The 340B contract pharmacy dispute involves several manufacturers who are refusing to provide 340B discounts to covered entities if they requested…

    Proposed Draft of House Compounding Legislation Released, Comments Wanted by Thursday June 20, 2013

    …a determination whether there is enough evidence to inspect the pharmacy in question.  The draft proposal gives FDA full inspection authority of a compounding pharmacy, but only if there is…

    FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

    The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. After its…

    Florida Proposes Plan to Import Drugs from Canada

    …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…

    Government Seeks to Dismiss Lawsuit Challenging the Canadian Drug Importation Rule

    …Canadian sellers from distributing drugs outside of Canada unless they have “reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug” in Canada….

    Biden “Promoting Competition” Executive Order Falls In Behind Drug Importation

    …difficult it will be to pass the statutory hurdle and obtain FDA approval to import drugs from Canada, and also pointed out that Canada’s Minister of Health has issued an…

    Pain Relief on the Way? Senator Kohl’s Proposed Bill to Provide Easier Access to Controlled Substances to Patients in Long-Term Care Facilities

    …The practitioner must then endorse and return within 5 days to the dispensing pharmacy the copy of the prescription that it received from the pharmacy.  The dispensing pharmacy must attach…

    Fifth Circuit Medical Center Pharmacy v. Mukasey Decision Creates Circuit Split Over FDCA § 503A Pharmacy Compounding “Safe Harbor”

    …Center Pharmacy v. Mukasey. In the early 1990s, FDA began asserting that the compounding of drugs without an NDA was unlawful.  FDA’s move spurred considerable controversy.  To resolve the dispute,…

    Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

    …the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy;…

    Congress Poised to Revamp TRICARE Retail Pharmacy Rebate Program

    …the VA, covered drug purchases under the TRICARE retail pharmacy program, authorized and paid for by the TRICARE Management Activity’s (“TMA’s”) Pharmacy Benefits Office, qualified for rebates to the FCPs….

    Recent OIG Advisory Opinions Involving Benefits Provided to Patients Are of Special Interest to Drug and Device Manufacturers

    …either the patient’s pharmacy or the prescriber can submit a request for the drug to the Program Pharmacy.  Once the Program Pharmacy confirms eligibility, a separate prescription for the drug…

    CMS Proposes Rule to Reduce Drug Costs Under Medicare Part D and Medicare Advantage

    …with a pharmacy as the amount the pharmacy will receive, in total, for a Part D drug, and it is also the pharmacy’s price to the enrollee, upon which the…

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  • Recent Posts
    • To Meet or Not to Meet: Day 70 and Counting July 18, 2025
    • Blood Pressure Rising: FDA Warning Letter Takes an Aggressive Approach on General Wellness Product July 17, 2025
    • CMS Proposals Would Raise the Bar on Bona Fide Service Fees for Average Sales Price July 16, 2025
    • ACI’s Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition July 15, 2025
    • Federal Hiring Shake-Up (Again): What the Latest Executive Action and Supreme Court Decision Mean for Industry July 14, 2025
  • Trackers
    • 180-Day Exclusivity Tracker
    • FDA Citizen Petition Tracker
    • REMS Tracker (Historical – Not Recently Updated)
    • FDA Legislation Tracker
  • Orange Book Archives

     

    ANDA Paragraph IV Patent Certifications List Archives

  • Scorecards
    • Generic Drug Labeling Carve-Out Scorecard
    • Biosimilars State Legislation Scorecard (Historical – Not Recently Updated) 
  • Blogroll
    • Big Molecule Watch Blog
    • Bloomberg BNA Health Care Blog
    • Drug and Device Law Blog
    • Eye on FDA
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    • Harvard Law Bill of Health
    • IN VIVO Blog
    • Internet Drug News.com
    • Lachman Consultants Blog
    • Medical Devices Today
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    • WLF Legal Pulse
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