Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
The following regulations have been amended and became effective July 30, 2018: ARTICLE IV LICENSE RENEWAL AND CONTINUING EDUCATION
The amendment increases the number of required annual continuing education hours from ten to fifteen and requires five of those hours to be related to opioid abuse or other addiction related issues. At least two hours of CE must be live CE. (The enforcement of this regulation will begin with the calendar year 2019. All pharmacists will be required to obtain the increased CE during the 2019 calendar year.)
ARTICLE VI PRACTICE OF PHARMACY PERMITS
The amendment allows for the delivery of home dialysis solutions to patients without the necessity of the distributor obtaining a pharmacy permit.
ARTICLE XLIII PMP
The amendment includes mandatory review of the PMP by pharmacists based on certain circumstances prior to dispensing opioids.
ARTICLE XLVI CHARITY PHARMACY REGULATIONS
The amendment allows retail pharmacies to participate in charitable drug distribution programs that have been approved by the Board.
ARTICLE XXXI COMPOUNDING GUIDELINES
The amendment incorporates the provisions from ARTICLE XXVII, STERILE PHARMACEUTICALS into this Article and Article XXVIII will be repealed. The amendment also requires pharmacies who are performing compounding services to obtain a compounding certificate. (The compounding certificate portion of this amendment will not be enforced until the Board develops an application for a compounding certificate. The application will be placed on the Board website after it has been developed and a notice will be sent to all pharmacists.)
PROCEDURES FOR PERMANENT CLOSURE OF BUSINESS
The amendment cleans up outdated information related to reporting to DEA and other agencies and streamlines the regulation.
COVER PAGE AND GENERAL INFORMATION
The amendment cleans up outdated information such as Board address, phone and fax number, etc.