December 13, 2018

December 13, 2018

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December 12, 2018

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December 11, 2018

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Board of Pharmacy Delays Requirement That Sole Proprietors Obtain Terminal Distributor’s License In Order to Compound Or Possess Compounded Drugs

The Ohio State Board of Pharmacy (Board) has extended the deadline for sole proprietors to obtain a Terminal Distributor of Dangerous Drugs (TDDD) license to September 1, 2016. We previously alerted you that as of May 1, 2016, the Board requires any prescriber who will possess, have custody or control of, or distribute dangerous drugs that are compounded or used for the purpose of compounding to be licensed as a TDDD.

After receiving feedback from impacted prescribers, the Board granted the extension to all prescribers who are performing drug compounding or ordering compounded drugs to their offices from the requirement to obtain a TDDD license. The Board will reconsider the scope of its new compounding rules and will provide further guidance following its July 2016 meeting.

It is important to note that this extension does not impact the implementation and enforcement of OAC 4729-16-11, which regulates prescriber compounding of hazardous drugs.

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About this Author

Eric J. Plinke, Dinsmore Law, Health Care Lawyer, Corporate Attorney
Partner

Eric Plinke is a Partner in the Corporate Department and Health Law Practice Group, and he routinely advises corporate and individual clients regarding a wide-range of health care industry legal issues. He has counseled clients in practice formation and acquisition, hospital and joint venture transactions, hospital and medical practice affiliations, contract review and preparation, compliance programs, HIPAA regulations, scope of practice issues, telemedicine and Stark law and Anti-kickback statutes, as well as significant experience counseling in ambulatory surgery centers and other joint...

614-227-4213
Sarah C. Persinger PharmD RPh, managed care lawyer & pharmacy benefits management attorney at Dinsmore Law Firm
Associate

Sarah is a member of our Health Care Practice Group. She holds a Doctor of Pharmacy degree and is a registered pharmacist with extensive pharmacy practice experience and a working knowledge of regulatory affairs. She has managed health system pharmacy compliance with Ohio State Board of Pharmacy, DEA, and CMS regulations, the federal 340B Drug Discount Program, USP 797 and FDA Sterile Compounding requirements, and Joint Commission and HFAP Accreditation standards. 

Sarah has a strong working knowledge of specialty pharmacy, managed care and pharmacy benefits management, HIPAA and healthcare information security, and trade association industry relations, as well as work experience in the retail, hospital, and long-term care pharmacy practice settings. 

Her experience enables her to provide comprehensive and strategic legal and compliance counsel to a wide variety of healthcare clients who operate in a complex and quickly-evolving regulatory environment. Sarah also provides legal services and advice throughout the lifecycle of complex healthcare transactions, and leverages her previous experience practicing pharmacy and managing health system pharmacy compliance, along with relationships she has developed with staff, members, and executive leaders of the Board of Pharmacy, to assist clients with obtaining licensure and navigating the board’s administrative hearing process.

Sarah has served as an adjunct professor at Ohio Northern University and visiting lecturer at Cedarville University, teaching about the legal and regulatory environment of the pharmaceutical industry and the profession of pharmacy.

(614) 628-6979
Daniel S. Zinsmaster, Dinsmore Law Firm, Health Care Lawyer
Partner

Dan provides trusted counsel and advocacy to health care clients on a variety of matters, such as corporate compliance, provider credentialing, administrative proceedings and litigation.  He also advises clients on practice formation and acquisition, as well as contract review and preparation.  In recent years, Dan has helped health care companies and providers navigate through fraud and abuse investigations, antitrust reviews, and other white collar criminal matters.  He is a frequent author and lecturer on telehealth and telemedicine issues.

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(614) 628-6949