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Question 2 of the Day September 23, 2013, Should Texas Be Called the Compounding Capital of the World? After all it is home to PCCA, IACP, and the Texas Board of Pharmacy Has No Idea How Many Compounding Pharmacies

IACP Believes Its Final Concerns About Language of Compounding Clarity Act (H3089) Can be Resolved so that the final legislation will appropriately and adequately safeguard the American public while not adversely affecting our profession’s commitment and ability to serve patients.

Sunday, September 22, 2013

IACP Position on the Compounding Clarity Act of 2013

Washington, D.C. (September 20, 2013) – The International Academy of Compounding Pharmacists (IACP) today acknowledges the introduction in the U.S. House of Representatives of the Compounding Clarity Act of 2013, a bill aimed at addressing problems of the type associated with last year’s deadly outbreak of meningitis linked to the now-closed New England Compounding Center in Framingham, MA. The IACP, a global professional association representing compounding pharmacists and practitioners, continues to work collaboratively with members of Congress and their staff, providing input and expertise on the issues surrounding the practice and regulation of pharmacy compounding. 

We believe the House bill makes many key improvements over legislation introduced earlier this year in the U.S. Senate. These improvements include the creation of a compounding advisory committee within the FDA as well as a communication system between the FDA and state boards of pharmacy to ensure that government regulators are working together rather than separately. While we support the general direction of the House bill, we do have several specific concerns that we are committed to resolving so that compounding pharmacists and physicians may continue to provide patients with the customized medications they need in an effective, timely and safe manner. 

First, the bill requires that, for compounded medications to be administered in a physician’s office, those administering the medications would be required to gather the names of individuals receiving the medication within seven days. The form and requirements of a prescription have traditionally been left to the legislative authority of the states and not the federal government. While well intended, we believe that this new mandate would create confusion between existing and evolving state policies on the provision of compounded preparations to physicians and other prescribers. IACP believes that individual state authority over, and regulation of, office-use medications must be recognized at the federal level. 

Second, the proposed legislation enables the FDA to prohibit the preparation of “demonstrably difficult” compounded medications. We believe that this provision needs to spell out the criteria by which the FDA makes the decision to put compounded medications on its list of these prohibited 

materials, as “demonstrably difficult” is not defined by the new law. Without such specifics, this provision is likely to lead to confusion as well as costly and unnecessary legal challenges. IACP supports clear language that enables the prohibition of compounded preparations based on clear scientific evidence of either safety or efficacy concerns. 

IACP believes that these and other concerns about language within the Compounding Clarity Act (H 3089) can be resolved so that the final legislation will appropriately and adequately safeguard the American public while not adversely affecting our profession’s commitment and ability to serve patients. 

quoted from Utah Pharmacists Association

In recent years, the International Academy of Compounding Pharmacists has invested over $1 million in lobbying efforts with Congress.

source found here

The Food and Drug Administration (FDA) has asked Congress to extend its oversight of large pharmacies that manufacture and distribute drugs, called compounding pharmacies. Currently, licensing for many of these facilities is the same as a mom-and-pop local pharmacy that sells one prescription at a time to customers. However, because these plants are actually making, storing and distributing drugs, their impact is more widespread and costly when a contamination issue exists.
Recently, authorities have linked a Tennessee pharmacy that makes and distributes steroids to an outbreak of fungal infections. During an inspection of the facilities, the FDA found spiders in a supposedly clean room, fungus and bacteria in vials of steroids, and no quality control procedures to monitor batches of the drugs being processed. There were 25 patients from four different states that that have developed infections after receiving injections of products from the Tennessee compounding pharmacy. The FDA says that the contamination may be similar to the 2012 case of the New England Compounding Center in which as many as 58 patients died after receiving steroid injections.

Not the First Time the FDA Has Tried

According to the Huffington Post, attempts by the FDA to increase its regulation of compounders date back to the 1990s. After strong pushback from the compounding industry, the FDA and the American public are left with the same vulnerabilities.
As reported by its trade group, the compounding pharmacy industry, which creates custom medicines by mixing drugs, does $3 billion of business in the U.S. and operates 7,500 pharmacies. In recent years, the International Academy of Compounding Pharmacists has invested over $1 million in lobbying efforts with Congress.
- See more at: http://1800theeagle.com/dangerous-drugs-news/2013/07/fda-inspection-unearths-utter-chaos-fungal-debacle/#sthash.BJ8WM00x.dpuf

The Food and Drug Administration (FDA) has asked Congress to extend its oversight of large pharmacies that manufacture and distribute drugs, called compounding pharmacies. Currently, licensing for many of these facilities is the same as a mom-and-pop local pharmacy that sells one prescription at a time to customers. However, because these plants are actually making, storing and distributing drugs, their impact is more widespread and costly when a contamination issue exists.
Recently, authorities have linked a Tennessee pharmacy that makes and distributes steroids to an outbreak of fungal infections. During an inspection of the facilities, the FDA found spiders in a supposedly clean room, fungus and bacteria in vials of steroids, and no quality control procedures to monitor batches of the drugs being processed. There were 25 patients from four different states that that have developed infections after receiving injections of products from the Tennessee compounding pharmacy. The FDA says that the contamination may be similar to the 2012 case of the New England Compounding Center in which as many as 58 patients died after receiving steroid injections.

Not the First Time the FDA Has Tried

According to the Huffington Post, attempts by the FDA to increase its regulation of compounders date back to the 1990s. After strong pushback from the compounding industry, the FDA and the American public are left with the same vulnerabilities.
As reported by its trade group, the compounding pharmacy industry, which creates custom medicines by mixing drugs, does $3 billion of business in the U.S. and operates 7,500 pharmacies. In recent years, the International Academy of Compounding Pharmacists has invested over $1 million in lobbying efforts with Congress.
- See more at: http://1800theeagle.com/dangerous-drugs-news/2013/07/fda-inspection-unearths-utter-chaos-fungal-debacle/#sthash.BJ8WM00x.dpuf

Head of nation’s largest specialty pharmacy group backs FDA regulation

The head of the nation’s largest trade group for the specialty pharmacies known as compounders said he will support legislation requiring pharmacies that operate like drug manufacturers to register with the Food and Drug Administration and be subject to stricter standards enforced by the agency.
The new position by the International Academy of Compounding Pharmacies follows a Washington Post investigation that showed 15 of the nation’s largest compounding pharmacies, which make custom-ordered medications, operate like drug manufacturers but do not have to register with the federal government or follow the same safety laws.
The Post also reported that shoddy equipment and unsanitary conditions at some of these firms had caused patient illnesses and deaths long before an October meningitis outbreak that was linked to tainted steroids made at a Massachusetts-based compounding pharmacy. Congress is investigating compounding pharmacies after steroid shots made at the New England Compounding Center were linked to the outbreak, which killed 47 people and sickened another 660.
“We want to enable and clarify for the FDA that those businesses that are involved in the manufacturing of compounded drugs, regardless of size, be regulated like drug manufacturers,” said David Miller, the academy’s executive vice president.
Miller and his 2,700-member group have traditionally argued that all pharmacies should fall under the purview of state pharmacy boards, not the FDA, and fought efforts in 2007 to shift primary oversight from the states to the federal government.
On Thursday, Miller said he now wants to see FDA registration for what he describes as compounding manufacturers and supports giving the agency the power to enforce safety standards for these firms.
“They’re singing a different tune,” said a congressional staffer who is knowledgeable about Capitol Hill discussions concerning the FDA’s role in regulating compounders.

Additional oversight is needed 

Officials who represent state regulators say the change reflects a broader shift in momentum. There is now agreement within the industry that additional oversight is needed for pharmacies that go beyond the traditional role of filling prescriptions for individual patients


Read more: http://www.voxxi.com/specialty-pharmarcy-group-fda-regulation/#ixzz2LdtEd4TQ

My Two Cents: IACP Just Made a Huge Step in the Right Direction Because They Will Now Have Input into Any New Federal Legislation and Regulations

It took David Miller and the International Association of Compounding Pharmacies awhile to jump on board with the new proposed federal legislation that would allow the FDA to oversee and enforce laws and regulations relating to compounders who are considered manufacturers, but this is a step in the right direction and a big step at that.  This is not to say that they or anyone agrees with the FDA taking over completely or part of the regulation of compounders.  What this does say to me is they saw the writing on the wall that some federal legislation is going to be passed into law.  So it is better for them to be on board and have a say in that legislation than to oppose it completely and have no say in the new federal laws and regulations.  With IACP backing the federal legislation that allows FDA limited oversight over compounders this helps prevent there being federal legislation that allows for the FDA to take over all compounding regulation and enforcement.  Now, in my opinion, what needs to happen it that Congress, the FDA, and the groups representing compounders need to come up with a fairly clear list of determining factors as to whether a compounding pharmacies qualifies as a "manufacturer" and is under whatever federal legislation is ultimately passed.  What are some of the factors that should determine if a compounding pharmacy is a manufacturer?

Breaking NEWS RE: IACP: Pharmacy trade group shifts position on federal oversight

By Kimberly Kindy and Lena H. Sun,

Feb 22, 2013 12:28 AM EST

The Washington Post Published: February 21

The head of the nation’s largest trade group for the specialty pharmacies known as compounders said he will support legislation requiring pharmacies that operate like drug manufacturers to register with the Food and Drug Administration and be subject to stricter standards enforced by the agency.
The new position by the International Academy of Compounding Pharmacists follows a Washington Post investigation that showed 15 of the nation’s largest compounding pharmacies, which make custom-ordered medications, operate like drug manufacturers but do not have to register with the federal government follow the same safety laws

Continue reading here

MONDAY, FEBRUARY 25, 2013

IACP's Response to the Washington Post Article - A Message from David Miller, at IACP

IACP launches Compounders Stateside web page

IACP has launched Compounders Stateside. which  will serve as a one-stop resource for state compounding updates and the latest happenings with the state Boards of Pharmacy.   That webpage can be found here

IACP Law Library-Compounding for Office Use Available for Purchase

As part of our ongoing development of tools, programs and materials that help our members improve their professional and business practice, IACP is launching its IACP Law Library. As conceived, this law library will provide pharmacists with a comprehensive analysis of state pharmacy law and regulation that affect many day-to-day decisions.

Our first installment in the new IACP Law Library—Compounding for Office-Use is now available for purchase! Click here for purchase information.

Overview of Results
The majority of the states (42) allows pharmacies to sell any non-controlled prescription drug and compounded drugs to practitioners for office use. Six states specifically prohibit that activity, and two states appear to be silent. Silent means the statutes and regulations do not specifically say whether it’s allowed. As our phone calls to the states Boards revealed, silent does not necessarily mean it is not allowed. Many of the states Boards confirmed that although the statutes or regulations don't say office use is specifically permitted, the Boards allow by broad interpretation, board policy, or by common practice covered by a pharmacy’s license the provision of office-use prescriptions.
For the most part, those states that do specifically prohibit office-use prescriptions provide for a “sales” process instead and require that in lieu of a prescription, orders from practitioners must be placed via an invoice. Several of these states limit the amount of product that a pharmacy can sell to a practitioner for office use to either 5% of the total annual sales or 5% of the total dosages in a consecutive 12-month period. This five percent figure appears in many of the states controlled substances laws and is being applied by the Boards to sales for office use in general.
The percentage limitation is from the federal DEA Controlled Substances Act and rules. The five percent language was placed into some of the states PDMA laws – which deal with wholesaler licensure -- where the allowing of sales for office use also is found in an exemption provided in the definition of wholesale drug distribution. In these states, sales to practitioners are not wholesale drug distribution and do not require a wholesaler license. Many of the states providing the exemption limit the sales to 5%. If sales exceed 5%, then a pharmacy would be required to obtain a wholesale drug distributor license.
Unanswered Questions
Even the best research has limitations. Three states did not respond to our numerous phone calls and emails for clarifications and additional information. They are: Georgia, Illinois, and New Jersey.

• Based on our review of the statutes and regulations, Georgia allows the sale to practitioners for legend drugs but is not clear as to whether such is allowed for compounded products.
• Illinois and New Jersey allow the sale of compounded products for office use but appear to be silent as to whether legend drugs may be sold to a practitioner for office use.

IACP members doing business in those states should confer with the Board of Pharmacy if they have any questions.

To read entire IACP statement click here