The Office of the Inspector General for Health and Human Services (OIG) issued a comprehensive review of the effectiveness of the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) for certain opioid-based drugs.... Read More
Chain Pharmacies | Life Sciences | Manufacturers | White Collar Criminal Defense & Government Investigations

If your pharmacy has been vandalized or looted in the recent riots that have affected many cities and towns across the country, depending on the issue, there may be a number of notifications that the pharmacy is required to make as it relates to the... Read More
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On April 30, 2020, the Food and Drug Administration (FDA) issued new guidance relaxing certain requirements under the Drug Supply Chain Security Act (DSCSA) for COVID-19 related drug products.  In the guidance, FDA explained that under the DSCSA... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Life Sciences | Pharmacy Law | Physician Dispensing | Specialty Pharmacies

https://www.youtube.com/watch?v=G2-iGKlATyU&feature=youtu.be In these trying times many pharmacies and medical practices are facing some degree of temporary shutdowns. Co-Founding Partner Jonathan Levitt, Esq. and our Managing Partner of our... Read More
Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Healthcare Law | Life Sciences | Pharmacy Law | Specialty Pharmacies

In May 2019, Oklahoma passed the Patient Right to Pharmacy Care Act ("Act"). The Act takes aim at unfair pharmacy benefit manager (“PBM”) practices by expanding network access for independent pharmacies, prohibiting PBMs from requiring patients... Read More
Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Life Sciences | Pharmacy Law | Specialty Pharmacies

In an effort to facilitate continuity of patient care and to respond appropriately to the circumstances that have arisen during the COVID-19 pandemic, the Drug Enforcement Administration (“DEA”) has recently announced three exceptions to DEA... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Life Sciences | Pharmacy Law | Physician Dispensing | Regulatory Compliance, including FDA, DEA and HIPAA | Specialty Pharmacies

Over the last few days, FDA has issued several guidance documents relating to compounding of certain aqueous injectable drugs by outsourcing facilities, State-licensed pharmacies and Federal facilities for duration of the COVID-19 public health... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Healthcare | Hospitals and Healthcare Systems | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Section 340B In-House and Contract Pharmacies

Pharmacists are frequently the first point of contact with a healthcare provider for many Americans. In an effort to implement large-scale testing for COVID-19, on April 8, 2020, the Office of the Assistant Secretary of Health, HHS, authorized... Read More
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Much of America is now entering the third week of social distancing, and with the President’s decision to extend Coronavirus mitigation guidelines through the end of April, businesses are bracing for continued interruption. Providers across the... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Life Sciences | Pharmacy Law | Specialty Pharmacies