Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies

Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies

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

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

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.

Virginia Board of Pharmacy Ad Hoc Committee to Meet Regarding Documentation Submitted from Registered Nonresident Pharmacies in Response to Recent Compounding Survey

Meeting to Be held on February 1, 2013, at 9:00 a.m.  To view agenda and for location click here

Michigan Introduces Bill Dealing With Pharmacies

SENATE BILL No. 92

January 29, 2013, Introduced by Senators GREEN, JONES, PROOS and HANSEN and referred to the Committee on Health Policy

  A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 16333, 17705, 17707, 17711, 17721, and 17731

(MCL 333.16333, 333.17705, 333.17707, 333.17711, 333.17721, and

333.17731), section 16333 as added by 1993 PA 80, section 17705

as amended by 1986 PA 304, section 17707 as amended by 1990 PA

333, sections 17711 and 17721 as amended by 2006 PA 390, and

section 17731 as amended by 1994 PA 234, and by adding sections

17735, 17736, and 17744a.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 1        Sec. 16333. Fees for a person licensed or seeking licensure

 2  to engage in the practice of pharmacy or other practices

 3  regulated under part 177 are as follows:

College of Veterinary Medicine to host 50th annual conference, alumni weekend | UGA Today

College of Veterinary Medicine to host 50th annual conference, alumni weekend | UGA Today

Dr. Lynn White-Shim of the American Veterinary Medical Association will present the two-hour Georgia laws, ethics and professionalism session on "Compounding: Are You Following the Rules?" for continuing education credit. For those interested in this session only, registration is $40.

Meningitis outbreak just ‘tip of the iceberg,’ ex-fed testifies

January 25, 2013

A former FDA regulator turned compounding pharmacy watchdog told state lawmakers the loosely regulated industry has gone unchecked for too long and warned the deadly nationwide fungal meningitis outbreak linked to Framingham-based New England Compounding Center just scrapes the surface of problems linked to the industry.

“This is one we know about,” Dr. Sarah Sellers told the Herald after her hourlong testimony on Beacon Hill yesterday. “What we don’t know about is even more concerning because most drug-related problems are very difficult to detect, so we’re only getting the tip of the iceberg.”

Sellers alleged the industry operates with huge profit margins but under far less regulation than big pharmaceutical companies.

 

But the industry fired back, saying regulators need to enforce rules already on the books and that major incidents at compounding pharmacies are rare.

“There is no indication that this is an industry that’s out of control,” said Todd Brown of the Massachusetts Independent Pharmacists Association. “This whole thing would have been prevented if the FDA had done their job, enforced their regulations and if the Board of Pharmacy had enforced their regulations.”

A top state health official told the Herald things are changing post-NECC.

“This tragedy has been a wake-up call to all different sectors of that industry and the regulatory arena as well,” said Madeleine Biondolillo of the Bureau of Health Care Safety and Quality. “We’re very confident that between the work we’ve done to inspect the industry and get a lot more information than was ever provided before, we’re going to be increasingly effective.”

State Sen. Mark Montigny (D-New Bedford), who accused the industry of exploiting a lack of regulation it helped create through intense lobbying, said he thinks the aftermath of NECC will make it easier for lawmakers to tighten the rules.

“They’ve already lost the opportunity for constructive feedback,” Montigny said.

 

Source found here

  

Testimony in MA that NECC was an accident waiting to happen and the compounding industry is rife with potential conflicts of interest

Montigny misses mark

January 28, 2013

Sen. Mark Montigny (D-New Bedford), who often targets Big Pharma and its lobbying efforts in his perpetual search for bad guys, may have actually found a better target in Little Pharma — those compounding pharmacies that have grown and grown and yet remained under the radar screen.

That is until 44 people died and 678 were sickened by fungal meningitis traced to the New England Compounding Center, which went virtually unregulated and uninspected until it was too late.

So last week Montigny chaired a meeting of the Senate Post Audit and Oversight Committee at which Dr. Sarah Sellers, a former compounding pharmacist and former Food and Drug Administration official testified that the NECC case was “an accident waiting to happen” and that the compounding industry is rife with potential conflicts of interest.

Montigny, of course, chose not to focus on the obvious — that the state Board of Registration in Pharmacy was itself rife with such conflicts and failed in its responsibility to regulate compounding pharmacies here. No, he chose to zero in on his favorite bete noir:

“When we allow special interests to ply their trade so successfully in Washington and in state capitols, the outcome is inevitable, and in this case deadly,” he insisted.

Yes it’s all about the lobbyists — really!

How about public officials who weren’t doing their jobs? How about greedy owners who even as people were dying and NECC was in bankruptcy proceedings were looting its treasury, according to their bankruptcy court filings?

It’s all shameful, but as usual the senator misses the point.

Source found here

American Society of Pharmacy Law Track and Annual Business Meeting: Mark the Date

ASPL Pharmacy Law Track and Annual Business Meeting

American Society for Pharmacy Law Track
ASPL will once again be sponsoring a series of sessions on Pharmacy Law at APhA 2013 in Los Angeles, CA March 1-4.  For more information about the APhA 2013 annual meeting, go to www.aphameeting.org.

Pharmacy Law Track:

• Case Law Update
• Legislative & Regulatory Update
• Hot Law Topics
• Warning: What You Don't Know Can Hurt You — Understanding the Consequences of State Board of Pharmacy Actions
• FDA Update
• HIPAA and HITECH: New Requirements for Privacy and Security
• Mitigating Your Legal Risk: Challenges to Compliance in the Current Regulatory Framework
• Pharmacy Social Media Boot Camp: Legal Issues

ASPL Annual Business Meeting
Please join us for the Annual Business Meeting and Reception to be held on Saturday, March 2, 2013, at 6:00 pm at the JW Marriott Hotel.