General Information

Government Type

State Agency

Entity

Department of Commerce > Division of Professional Licensing (DOPL)

Entity Website

dopl.utah.gov

Public Body

Dentist and Dental Hygienist Licensing Board

Notice Information

Add Notice to Calendar

Notice Title

Dentist and Dental Hygienist Licensing Board meeting

Notice Tags

Occupational Licensing

Notice Type(s)

Meeting

Event Start Date & Time

June 3, 2022 09:00 AM

Description/Agenda

Utah Division of Corporation Registration Number. In accordance with Utah Code §16-10a-1501, requires that businesses located outside Utah register with the Utah Division of Corporations and Commercial Code before transacting business in the State of Utah. You failed to submit your Utah Division of Corporation Registration Number with your application. Merck Sharp & Dohme LLC must be registered with the Utah Division of Corporations and Commercial Code as the correct business organization entity type. Once you register your business with the Utah Division of Corporations and Commercial Code, submit your assigned registration number to our office. NOTE: You may reach The Division of Corporations and Commercial Code at www.corporations.utah.gov or 1-877-526-3994. Response: Please find the attached Utah Division of Corporations and Code Registration. The Utah Division of Corporation Registration Number: 12829645-0161. Official Verification of License for new name. In accordance with Utah Code §58-17b-306(1)(c). Qualifications for licensure as a pharmacy must present to the division verification of licensure in the state where physically located and verification that such license is in good standing; You failed to include an official verification of license from the state where the pharmacy or business is physically located. Please provide an official verification of license or primary source verification to our offices by the due date below. Response: Please find the attached resident state license for Merck Sharp & Dohme LLC., 'PA WP WHS 2023'. Inspection report under new name. In accordance with Utah Code §58-17b-306(1)(d). Qualifications for licensure as a pharmacy. (1)Each applicant for licensure under this section, except for those applying for a class D license, shall: d) demonstrate the licensee's operations will be in accordance with federal, state, and local laws relating to the type of activity engaged in by the licensee, including regulations of the Federal Drug Enforcement Administration and Food and Drug Administration; You failed to include a copy of the most recent inspection report under your new name from the Board of Pharmacy of the state where the pharmacy is physically located, or NABP VAWD Inspection, completed within the last two years indicating compliance with laws and regulations. If an inspection is not available under the new name, please submit a written statement explaining why Response: Merck Sharp & Dohme LLC is the new name for what had been Merck Sharp & Dohme Corp., resulting from a formal change in corporate structure but with no change in operations, address, physical facility, or personnel. Both the LLC and Corp. are or were subsidiaries of Merck & Co., Inc. Licensee's operations were inspected by the United States Food and Drug Administration (FDA) in July 2021, and by the National Association of Boards of Pharmacy in 2020 under its Drug Distributor Accreditation program (NABP DDA). The FDA inspection resulted in four observations, which Merck Sharp & Dohme Corp. addressed by written response to FDA on August 9, 2021 with no further action from the FDA. The NABP DDA inspection resulted in a written determination that the facility is operating in compliance with program criteria. Given that the change from Merck Sharp & Dohme Corp. to Merck Sharp & Dohme LLC is a formal legal change only, with the operations, address, physical facility, and personnel remaining the same, these FDA and NABP DDA inspections establish that Merck Sharp & Dohme LLC as the applicant will operate in accordance with law. Please find the attached inspection report for Merck, West Point, Pennsylvania, and NABP certificate, and inspection letter. Drug Enforcement Administration (DEA) registration. In accordance with Utah Admin. Code R156-17b[1]615(17)(c), a valid DEA Registration is required in order to hold a Utah Controlled Substance License for those that hold or are applying for a Pharmacy Class C license. (17) Each facility shall comply with laws including: (c) obtaining a controlled substance license from the Division and registering with the Drug Enforcement Administration (DEA) if they engage in distribution or manufacturing of controlled substances and shall comply with all federal, state and local regulations applicable to the distribution or manufacturing of controlled substances. Please submit a valid Drug Enforcement Administration (DEA) registration for the facility and address listed on the application for licensure for the Utah Controlled Substance License. Response: Respectfully, as explained in our prior correspondence to the Bureau seeking further guidance on this item, we do not believe we are required to submit a DEA registration for Merck Sharp & Dohme LLC for its West Point, Pennsylvania address. Under Utah Admin. Code R156-17b-615(17)(c), a facility with a Class C Utah license must obtain a controlled substance license from Utah and register with DEA 'if they engage in distribution or manufacturing of controlled substances.' Here, Merck Sharp & Dohme LLC will market and sell the insomnia medication Belsomra (suvorexant), which is a schedule IV controlled substance under federal law. However, all physical distribution of Belsomra into Utah and other states will be by a 3PL, MD Logistics, which maintains DEA and state controlled substances registrations. Manufacturing will be by a Merck corporate affiliate, which also has a DEA registration. Because Merck Sharp & Dohme LLC does not physically manufacture or distribute Belsomra or any other controlled substance, it will not have a DEA registration. Please find the attached copy of our third-party logistics provider, MD Logistics LLC, DEA Distributor Registration.

Notice of Special Accommodations (ADA)

In compliance with the Americans with Disabilities Act, individuals needing special accommodations (including auxiliary communicative aids and services) during this meeting should notify the Division ADA Coordinator at least three working days prior to the meeting. Division of Occupational & Professional Licensing, 160 East 300 South, Salt Lake City, Utah 84115, (801) 530-6628 or toll-free in Utah only (866) 275-3675.

Notice of Electronic or Telephone Participation

Electronic participation is planned for this meeting.

Meeting Information

Meeting Location

160 East 300 South - 4th floor
Salt Lake City, UT 84111
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Contact Name

Lisa Martin

Contact Email

lmartin@utah.gov

Notice Posting Details

Notice Posted On

May 09, 2022 04:42 PM

Notice Last Edited On

September 19, 2022 09:36 AM

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