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
Wednesday, January 30, 2013
Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled
2013-1 ~ Compounding for Prescriber's Use (aka compounding for office use) 12-13-2012 Board issued Declaration of Emergency & Emergency Rule, effective immediately.
12-16-2012 Distributed electronic Notice of Emergency Rule to List of Interested Parties, all pharmacies, and all pharmacists.
12-17-2012 Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
01-18-2013 Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule. The effect of that decision was to void the December 13, 2012 Emergency Rule, effective immediately. However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
01-18-2013 Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to List of Interested Parties, all pharmacies, and all pharmacists.
01-20-2013 1st Report: Notice of Intent
02-27-2013 Public Hearing
source found here
12-16-2012 Distributed electronic Notice of Emergency Rule to List of Interested Parties, all pharmacies, and all pharmacists.
12-17-2012 Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
01-18-2013 Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule. The effect of that decision was to void the December 13, 2012 Emergency Rule, effective immediately. However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
01-18-2013 Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to List of Interested Parties, all pharmacies, and all pharmacists.
01-20-2013 1st Report: Notice of Intent
02-27-2013 Public Hearing
source found here
Tuesday, January 29, 2013
Virginia Bill 2312 Dealing With Compounding Introduced
On January 18, 2013, VA Bill 2312, was introduced into legislation. This bill includes new definitions and regulation of compounding. The bill would permit the Virginia Board of Pharmacy to revoke or suspend a pharmacy permit if the Board believes the actions of the pharmacy are of imminent threat to the citizens of the state. Language also is proposed that provides additional explanation to anticipatory compounding and defines compounding activities in "inordinate quantities" over anticipated patterns of prescribing and dispensing as manufacturing.
To view this bill click here
To view this bill click here
Oklahoma State Board of Pharmacy Inspections Stats
From information provided by Cindy Hamilton, D. Ph. Chief Compliance Officer for the Oklahoma State Board of Pharmacy, the Oklahoma Board of Pharmacy conducted 1173 inspections in 2011 and 1155 inspections in 2012. Oklahoma has 1142 pharmacies and 400 facilities located in the State of Oklahoma. These inspections include pharmacies and facilities (medical gas suppliers, wholesalers, manufacturers, etc.) The Oklahoma Pharmacy Board attempts to inspect each registrant once a year unannounced. However, for the past two years the Oklahoma Pharmacy Board has been short a compliance officer. The board does not keep individual statistics on the number of compounding pharmacies inspected.
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