Antibiotics Coalition Wants Drug Companies to Stop Growth Promotion Marketing

Keep Antibiotics Working (KAW) is on the Food and Drug Administration’s (FDA) case again about the growth promotion marketing loophole for antibiotics.

Last May, KAW alerted FDA to their concerns that drug manufacturer Novartis was using promotional materials for a feed additive used to treat dysentery and pneumonia and enteric disease in pigs that spoke more to production issues than animal health. FDA told the coalition via email that they had discussed the issue with Novartis, but the agency would not reveal any details about the substance of their conversation.

In June, KAW noticed that the company had modified the drug’s marketing page for the better, but the coalition didn’t think the changes were adequate. They met with FDA in July to explain their overall concerns and to ask the agency to clarify that this type of advertising would not be tolerated.

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New Jersey Society of Health-System Pharmacists: Southern Chapter - Pharmacy Law Update - A Look Back at 2014 and What to Expect in 2015

Southern Chapter - Pharmacy Law Update - A Look Back at 2014 and What to Expect in 2015

Start Date/Time:	Tuesday, November 18, 2014 5:30 PM
End Date/Time:	Tuesday, November 18, 2014 9:00 PM
Recurring Event:	One time event
Importance:	Normal Priority
Category:	Southern Chapter
Description:	Pharmacy Law Update - A Look Back at 2014 and What to Expect in 2015(NJSHP MEMBERS ONLY!) PRESENTED BY: Angelo Cifaldi, RPh, JD Wilentz, Goldman & Spitzer Vice-President and Chairman of the Mass Tort/Class Action Dept. Woodbridge, NJ WHEN: Tuesday, November 18, 2014 LOCATION: Maggiano's Little Italy 2000 Route 38, Suite 1180 Cherry Hill, NJ 08002-2100 TIME: 5:30 - 6:00 PM Registration 6:00 - 6:30 PM Dinner 6:30 - 7:00 PM Business Meeting 7:00 - 9:00 PM Presentation RESERVATIONS ARE REQUIRED BY Monday, November 10, 2014, at 2 PM to:  CLICK HERE New Jersey Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education, as a provider of continuing pharmacy education.  Pharmacists: ACPE #0152-0000-14-065-L03-P Technicians: ACPE #0152-0000-14-065-L03-T This is a knowledge-based law program for pharmacists and technicians. This program provides 2 contact hours of continuing education credits. Financial support for this meeting was received from AstraZeneca, Bristol-Myers Squibb, and Pfizer. This program is being sponsored by the Southern Chapter of NJSHP. CLICK BELOW FOR COMPLETE DETAILS: South_111814

Florida Pharmacy Association Law and Regulatory Conference-Sarasota

Law and Regulatory Conference - Sarasota 

 

12/6/2014 to 12/7/2014

When:	12/6/2014 07:00
Where:	Map this event » Hyatt Regency Sarasota 1000 Blvd of the Arts Sarasota, Florida  34236 United States
Contact:	Stacey Brooks sbrooks@pharmview.com

Ohio Board of Pharmacy FY 2014 Annual Report: Includes Statistics on Inspections, etc.

Ohio State Board of Pharmacy FY 2014 Annual Report

Be sure to read RX Trace Who Is A DSCSA Repackager? November 3rd, 2014 | Author: Dirk Rodgers

here

Ohio Application and Guidance for Outsourcing Facilities and Wholesalers Regarding Compounded Drugs

• Application for Outsourcing Wholesalers in or out of state
• Guidance Document - Licensing Outsourcing Facilities in Ohio

Does anyone know what happened during the Ohio Board of Pharmacy adjudication hearing with Davis Drug Compounding Infusion c/o Daniel Lee Sidwell, R.Ph., Caldwell, Ohio held in August 2014?

Ohio Board of Pharmacy Notice of Hearing Set for November 4, 2014 Regarding Pain Care Specialists, c/o Pandurango Rao Lingam, Dublin, Ohio and Hilliard, Ohio and H&H Wholesale Services, Inc., c/o Andrew Sweet, Troy, Michigan

Tuesday, November 4, 2014

8:30 a.m. 9:00 a.m.
9:00 a.m.
1:30 p.m. 2:00 p.m. 3:00 p.m.

ROLL CALL/ADMINISTRATIVE MATTERS (continued)
LEGISLATIVE REPORT/RULES UPDATE – Cameron McNamee, Legislative Liaison
ADJUDICATION HEARING – Pain Care Specialists, c/o Pandurango Rao Lingam, Dublin, Ohio
ADJUDICATION HEARING – Pain Care Specialists, c/o Pandurango Rao Lingam, Hilliard, Ohio
RECIPROCITY CANDIDATES REVIEW (Room South A, 31st Floor)
ADJUDICATION HEARING – Scott Thomas Druley, R.Ph., Tipp City, Ohio
ADJUDICATION HEARING – H&H Wholesale Services, Inc., c/o Andrew Sweet, Troy, Michigan
quoted from here 

Ohio Board of Pharmacy Notice of Hearing Set for December 2, 2014 Regarding Intent to Promulgate New Rules Including a Number of Rules relating to Compounding

This is a statement of the agency’s intention to promulgate the following rules:
New Rules

•   4729-7-10: Outlines Board of Pharmacy provisions relating to the licensure of veterans and military families. Includes all Board policies regarding fee waivers, continuing education and license renewal extensions for veterans and military families.
  
•   4729-16-03: Provides the requirements for drugs compounded in a pharmacy.
  
•   4729-16-04: Provides the requirements drugs compounded by a physician.
  
•   4729-16-05: Provides the requirements for drugs compounded in a fluid therapy pharmacy.
  
•   4729-16-06: Provides the recordkeeping requirements for pharmacies and prescribers when compounding drugs.
  
•   4729-16-07: Permits an in-state pharmacy to provide non-patient specific compounded drugs to a prescriber in limited quantities and in specific circumstances.
  
•   4729-16-08: Provides the requirement for drugs compounded by a nonresident (i.e. out-of-state) pharmacy.
  
•   4729-16-09: Requires all prescribers that are ordering compounded drugs and compounding drugs on site to
  have a terminal distributor license. This is to reflect a recent law change in HB 483 (130th General Assembly).
  
•   4729-16-10: Permits an in-state pharmacy to provide non-patient specific compounded drugs to a health care facility in the event of drug shortage. The health care facility and in-state pharmacy are required to notify the Board’s Executive Director.
  Amended Rules
  

•   4729-5-12: Provides the criminal records checks for pharmacists and pharmacy interns. Requires a pharmacist who lets their license lapse for more than three years to submit to a criminal background check if requesting a pharmacist or pharmacy intern license.
  
•   4729-5-21: Provides the manner with which a prescription must be processed by a pharmacy. Allows a pharmacy to document the administration of an immunization on a prescription form in order to allow a pharmacy to bill an individual’s health insurance.
  
•   4729-16-01: Provides definitions for a new rule chapter on compounding of dangerous drugs. Amended Rules (5 Year Review)
  

 4729-21-06: Provides the approved courses that divers must complete before they are allowed to purchase and utilize medical oxygen. Authorizes individuals who have completed courses from the National Association of Underwater Instructors to purchase and possess medical oxygen for the purpose of emergency care or treatment at the scene of a diving emergency.

•   4729-15-03: Sets the minimum standards for a nuclear pharmacy. Updates a cross reference to a new compounding chapter (Chapter 16). This chapter will be in effect prior to the effective date of this rule.
  
•   4729-5-27: Provides the record keeping for the practice of pharmacy in an outpatient setting. Updates the rule to reflect current technology.
  
•   4729-5-30: Provides the manner in which a valid prescription must be issued by a prescriber in order to be dispensed by a pharmacy. Updates a cross reference to a new compounding chapter (Chapter 16). This chapter will be in effect prior to the effective date of this rule.
  
•   4729-21-03: Requires sellers of compressed medical gas to keep records for three years. Updates current terminology for a Board of Pharmacy agent to match other record keeping sections of the Administrative Code.
  
•   4729-22-04: Prior to selling medical oxygen to a patient, the retail seller must have an order issued by a prescriber. Allows for the electronic transmission of an order for medical oxygen
  
•   4729-13-01: Provides the definitional section for the OAC chapter for laboratory licensure. This rule is amended to update an incorrect cross reference to the ORC.
  
•   4729-13-02: Provides the procedure for Board approval as a laboratory, including licensure as a terminal distributor of dangerous drugs.
  
•   4729-14-01: Provides the definitional section for the OAC chapter for animal shelter licensure. This rule is amended to update an incorrect cross reference to the ORC.
  
•   4729-14-02: Provides the procedure for obtaining a terminal distributor of dangerous drugs from the Board. Rescinded Rules
  

•   Chapter 4729-19
  
•   Chapter 4729-31
  
•   4729-9-25
  
•   4729-5-25
  The full text of the rules is available at the office of the State Board of Pharmacy in printed form without charge to any person affected by such proposals. The rules are also available on the Register of Ohio web site at www.registerofohio.state.oh.us.
  On the date and at the time and place designated in this notice, any person affected by the proposed action of the State Board of Pharmacy may appear and be heard in person, by his/her attorney, or both; may present his/her position, arguments, or contentions orally or in writing; offer witnesses; and, present evidence tending to show that any proposal, if adopted or effectuated, will be unreasonable or unlawful.
  Eric Griffin
  Interim Executive Director 
  source quoted from here
  

FDA Slide: Reminder Regarding Responsibilities Relating to API