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Mum’s the Word on Hearing Aids
…through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local…
Code ORANGE: The Orange Book Archives Have Arrived!
…Orange Book – that is, all of the prior editions and supplements from the 1979 draft edition to the current 2020 BPCIA Transition edition and beyond – were available online…
Specialty Pharmaceutical Distribution Company Pays $10.5M and Enters into a Deferred Prosecution Agreement with the Mass. U.S. Attorney’s Office Over Illegal HGH Distribution
…section of the paper. In a seemingly unrelated investigation, the District Attorney for Albany County, New York, David Soares, has investigated and charged Specialty Pharmacy of Orlando, Florida, and top…
More Information about Nevada Compliance Program Law
A colleague of your trusted bloggers spoke with counsel for the Nevada Board of Pharmacy (“BOP”) and reports the following about the new law in our post from yesterday: A…
DoD Loses a Battle but Wins the War on TRICARE Retail Refunds
…Authorization Act of 2008 (NDAA 08). That section provides that prescriptions filled on or after January 28, 2008 (the enactment date) and paid for under the TRICARE retail pharmacy program are…
2023 IS the Year for OTC Naloxone!
…Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and…
Hospitals: Do You Know Where Your Controlled Substances Are?
…a Non-Prosecution Agreement in June 2022 after a pharmacy tech diverted more than 11,000 schedule II doses and another 1,900 schedule III-V doses. A registered nurse also admitted she replaced…
Sixth Circuit Affirms Dismissal of Off-Label Promotion FCA Case for Lack of Rule 9(b) Specificity
…improperly promoted the product must have prescribed the medication for an off-label use; The patient must have filled that prescription; and The filling pharmacy must have submitted a claim to…
Nevada Department of Health and Human Services to Exercise Enforcement Discretion for Required Reports under Drug Pricing Transparency Law
As we previously reported, Nevada enacted a law on June 15, 2017 addressing drug prices. S.B. 539 imposed new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”) related…
Pharmaceutical Manufacturers Must Submit 340B Ceiling Prices Starting in the First Quarter of 2019
…Pharmacy Affairs (“OPA”) has developed an electronic system for manufacturers to report their 340B ceiling prices, using HRSA’s Office of Pharmacy Affairs Information System (“OPAIS”). OPAIS was launched in 2017…
Finally Getting Bulky: Six Years After Enactment of the DQSA, FDA Publishes First Final Rule for the Section 503A Bulks Substance List (and It Includes Six Drug Substances!)
…Pharmacy Compounding Advisory Committee. The Final Rule also identifies four substances that FDA has determined may not be used in compounding, and provides information on factors that FDA will consider…
FDA Rejects Requests to Initiate Rulemaking for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions
…because TE ratings are far more than advisory: They have been expressly incorporated into state pharmacy practice statutes that control which drug products pharmacists may dispense and, therefore, which drug…
Mainers and FDC Act Preemption “In”, and PhRMA and Foreign Commerce Clause “Out” in Dispute Over Drug Importation Law
…September by two Maine pharmacists, three Maine trade associations (the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and Retail Association of Maine), and the Pharmaceutical Research and Manufacturers of…
Congressional Hearing on “Improving Predictability and Transparency in DEA and FDA Regulation” On Monday, April 7th at 3PM; Three Bills Appear on the Agenda
…and at least one nationwide retail pharmacy in the past few years where the subject of those immediate suspension orders involved conduct that occurred — and typically had resolved –…
Citizen Petition Requests Rulemaking Process for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions
…drugs,” for two primary reasons: First, TE listings are now far more than advisory. They have been expressly incorporated into state pharmacy practice statutes that control which drug products pharmacists…