Florida State Surgeon General Tours Compounding Pharmacy

Contact: DOH Communications
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STATE SURGEON GENERAL TOURS COMPOUNDING PHARMACY IN PENSACOLA
~Representative Clay Ingram tours Pensacola Apothecary with Dr. Armstrong~

TALLAHASSEE- Florida Surgeon General and Secretary of Health Dr. John Armstrong was recently joined by Representative Clay Ingram, R-Pensacola, in a tour of Pensacola Apothecary, a compounding pharmacy in Pensacola, Fla. The local pharmacy provides services to Northwest Florida physicians and specializes in formulating and customizing medications to meet the special health needs of patients and to assist where certain medications are not available. With recent discussions regarding compounding practices in the state and across the nation, this tour presented a unique opportunity to gain first-hand knowledge of the practice and to work with the Board of Pharmacy in its ongoing discussions of changes to best protect all Floridians.

“Pensacola Apothecary serves as an industry standard for quality of service and safe practices,” said Dr. Armstrong. “These strict quality standards should be the benchmark for all compounding pharmacies so that patients in Florida receive safe compounded medications.”

Supervising pharmacist Christopher Schulte manages Pensacola Apothecary, a community and special parenteral and enteral pharmacy. A parenteral and enteral pharmacy is licensed to compound sterile medications such as intravenous “IV” therapy and nutrition, irrigation solutions, feeding tubes and other sterile products such as eye drops. Pensacola Apothecary opened its doors in 2003 and is Northwest Florida’s only Pharmacy Compounding Accreditation Board (PCAB) accredited pharmacy, the highest quality and safety standards in the profession.

“Pensacola is fortunate to be served by one of the state’s leaders in safe, high-quality compounding,” said Rep. Clay Ingram. “I personally saw the extraordinary measures taken by Pensacola Apothecary to ensure that patients are protected, and that kind of commitment to safety sets a wonderful example for other compounding pharmacies in Florida.”

National conversations have emerged regarding the safety of compounded medications as the result of the fungal meningitis caused by contaminated injectable products compounded at the New England Compounding Center in Framingham, Mass. The Florida Department of Health, along with the Florida Board of Pharmacy will continue to review current regulation of Florida’s pharmacies to identify measures for improvement. Results from a mandatory compounding practice survey have recently been released and will serve as a guide to future rulemaking in order to protect patients without creating unduly burdensome regulation.

DOH protects, promotes and improves the health of all people in Florida through integrated state, county and community efforts.

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Aren't We All In This Boat Together And All Looking For the Right Solution? APhA's Position is Refreshing.

One of my favorite times to write is late at night when the house is quite.  Actually it is a habit.  While working at the U.S. Attorney's Office most nights  I had to stay up and work after everyone else at my house had gone to bed.  Deadlines come fast and furious in the federal government's legal world.  Long hours are the norm.   Attorneys do their best not to miss deadlines for a number of reasons--there are the ethical reasons--sanctions from the court, causing your side to lose, etc.  As AUSA(Assistant United States Attorneys)  there was another reason.  When you are sworn in as an AUSA you take an oath of office--this is after all the background checks and security clearances-deeming you worthy of these positions.  The oath is a pledge that you will represent and defend the United States of America.  Most AUSAs, if not all,  take this oath extremely serious.  After all isn't it extremely serious to represent and defend  one's country.   Does that, however, make one pro-government?  I suppose that depends on what one means by the use of the word pro-government?  Does pro-government always mean that you believe in more, bigger government?  No. It does not.  Pro-government can also mean you believe in your government--the United States of America-and that you will represent and defend it as necessary.
At times as an AUSA you might be asked to defend a law that you personally did not believe in.  That was the job you were paid to do. A lot of times you are required to advocate a position that is not your personal belief, but again that is what you are required to do even when you thought it made you look disingenuous.

Likewise, does anti-government mean you hate government of any kind?  Does it mean you prefer state government over the federal government to regulate certain areas?  Does it mean government can be big as long as it is state government doing the regulating and not the federal government?  Again, I think different people have different ideas of what these terms mean.  I know I have been labeled by some as pro-government because I spent a great part of my legal career representing the United States of America and defending the Constitution and the rights it provides.  I took my job very, very seriously as an AUSA, and I tried to honor the oath I swore to,  I also represented the great state of Oklahoma as an Assistant Attorney General and took an oath there also.  People don't seem to focus on that job.  Does that job make me pro-state government?  How do you mesh the two and come up with the right label for me if you are simply basing it on where I worked and nothing else?  Is it really fair to label me at all simply because I have a background in federal and state jurisdiction and understand the legal ins and outs and some of the legal challenges of both?

There are both sound arguments for and against the FDA taking over all or a bigger part of regulating compounding.  Similarly, there are sound arguments for and against the states continuing to regulate compounding.  APhA's position announced on the blog earlier today was refreshing.  It was refreshing to see thatAPhA's is considering options even though it involves change. It is refreshing that APhA wishes to continue the dialogue with the FDA and work to find the best solution.

The point of this blog is and always has been to educate, inform and open up the dialogue regarding issues in the compounding world.  Is this blog meant to be negative toward compounding? Absolutely not, but it is meant to present multiple sides and views.  The recent events of NECC have caused a negative spin on compounding. That may be unfortunate, but it is the reality. On a recent post when I asked readers to comment on the positive of compounding, I got no responses despite the post being well read.  I still welcome any and all positive stories that readers want to share about compounding.
I hope that others will be open to new ideas and solutions to make the compounding world a better safer place no matter who ultimately is in charge of regulating it.

Repost: APHA's page Explaining necessity of compounding and how all compounding is subject to both state and federal regulations already

Frequently Asked Questions About Pharmaceutical Compounding

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Last Updated: November 19, 2012

What is pharmaceutical compounding and why is it necessary?

Compounding is the creation of a pharmaceutical  preparation – a drug – by a licensed pharmacist to meet the unique needs of an individual patient when commercially available drugs do not meet those needs. A patient may not be able to take the commercially available drug, or a patient may require a drug that is currently in shortage or discontinued.

These are a few examples of the ways a compounding pharmacist can customize medications with a doctor’s prescription to meet a patient’s needs:

• Adjust strength or dosage.
• Flavor a medication, for example to make it more palatable for a child.
• Reformulate the drug to exclude an unwanted, nonessential ingredient, such as gluten or a dye that a patient is allergic to.
• Change the form of the medication for patients who, for example, have difficulty swallowing or experience stomach upset when taking oral medication.

Compounding pharmacists can put drugs into specially flavored liquids, topical creams, suppositories, or other dosage forms suitable for patients’ unique needs. Compounding does not replicate commercially available drug products.

How is pharmaceutical compounding different from drug manufacturing?

Compounding is the preparation of an individual drug to meet the prescriber’s exact specifications and to be dispensed directly to the patient or the prescriber. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy (see below question on legal oversight of compounding versus manufacturing). Compounded drugs are not for resale by the patient or prescriber.

Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA). These products are sold to pharmacies, health care practitioners or others authorized under state and federal law to resell them.

What is a compounding pharmacy?

While all pharmacies do some types of compounding, this is more common or the primary focus of a small portion of American pharmacies. The preparations  offered by these compounding pharmacies can be nonsterile (ointments, creams, liquids, or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (usually intended for injection into body tissues or the blood).

All licensed pharmacists learn during their four years of pharmacy school to perform basic compounding. In addition, all pharmacies have compounding tools such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, scales for weighing solids, spatulas for mixing materials, and pill tiles on which to work. With such tools and applying their knowledge, all pharmacists routinely prepare nonsterile compounded products when requested by physicians.

Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all of their time compounding special preparations  for patients. Preparations in these pharmacies are more likely to be both sterile and nonsterile. Compounding also takes place in hospital pharmacies and at other health care facilities.

Who regulates compounding pharmacies? Do compounding pharmacies follow the same regulations as drug manufacturers? Why or why not?

All pharmacists and pharmacies involved in compounding are subject to oversight by both federal and state authorities.

The practice of compounding is regulated by state boards of pharmacy. Pharmacists engaged in compounding are expected to follow appropriate procedures for the types of preparations that are compounded.

FDA has oversight for the integrity of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations.

The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications. Controlled substances include narcotics such as hydrocodone, amphetamines and similar drugs, and drugs such as those used for anxiety and sleep disorders.

In addition, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This quasigovernmental organization defines the chemical composition of drugs and also issues practice standards. Two standards in particular are relevant to compounding pharmacists.

Continue reading here

FDA works with pharmacy, states on compounding; NOT On Mission to Stop Compounding Per APHA

By now, we’re all aware of the terrible tragedy and 39 deaths that resulted when unfortunate and unsuspecting patients were injected with products inappropriately manufactured by a pharmacy in Massachusetts that called itself a compounding pharmacy.

Yesterday FDA held a closed intergovernmental meeting on a Framework for Pharmacy Compounding: State and Federal Roles for representatives from all 50 states as well as FDA staff—more than 100 people in all.

The last 2 hours of the meeting were public. In opening remarks, FDA Commissioner Margaret A. Hamburg, MD, noted that the agency had spoken with more than 50 different organizations, including pharmacy groups, leading up to the meeting. “Today was the states’ turn,” Hamburg said, to discuss four questions that get to the heart of federal and state roles. What FDA heard underscores the need for new legislation, she added.

During the public discussion of the questions, state representatives zeroed in on the need for clear definitions of pharmacy compounding versus manufacturing, and better communication among states and between FDA and states. Cody Wiberg, PharmD, MS, Executive Director of the Minnesota Board of Pharmacy, said at the meeting that most states have the authority and resources to handle traditional compounding, but fewer states may have the resources to handle nontraditional compounding in facilities like the New England Compounding Center (NECC). “I think the consensus in our group was in the latter case, with NECC, there is a role for the FDA to be involved,” Wiberg said.

Hamburg responded minutes later that the issue about defining the terms—compounder, manufacturer—and how that then aligns with regulatory actions is “just so, so fundamental.” She suggested a working group to address the issue.

Another takeaway from the meeting was the National Association of Boards of Pharmacy’s work with the Iowa Board of Pharmacy to start investigating out-of-state pharmacies, leading in turn to the creation of a database for all boards of pharmacy that will track the licenses and disciplinary measures taken against pharmacies nationwide. 

FDA’s meeting with states followed a separate meeting with FDA that I attended on December 14 with about a dozen other national pharmacy organizations and stakeholders. We discussed the agency’s interest, among other things, in a clear distinction between manufacturing and compounding that could allow state and federal regulators to better protect the public.

Representing APhA, I shared the perspective that pharmacy is committed to doing everything possible to enhance patient safety while maintaining access to our compounding services. We promoted greater recognition of Pharmacy Compounding Accreditation Board standards and offered some suggestions on ways to help differentiate compounding from manufacturing.

FDA is not on a mission to stop compounding, as may have been the perception in prior years. Rather, they are looking for ways to better define manufacturing, which they see as their responsibility to regulate and to enforce maintenance of good practices. We appreciated FDA’s recognition of the value of compounding and did not observe any interest on their part in hindering that practice. Their goal is to better regulate manufacturing in order to protect the public.

This discussion is just beginning, but based on FDA’s posture on the 14th, we’ll be at the table throughout the debate.

More to follow on this. Meanwhile, you are encouraged to comment on the agency’s four questions—outlined in the November 28 Federal Register notice for the FDA meeting with states—due January 18, 2013. And remember, APhA continues to post compounding updates and resources on pharmacist.com at Just the Facts: Compounding. 

Source found here--APHA website.

BREAKING NEWS: APHA Supports FDA's Proposed Regulatory Framework For Pharmacy Compounding

n print

January 29, 2013

Comment letter follows agency’s intergovernmental meetings considering a FDA risk-based framework that would create two categories of compounding: “traditional” and “nontraditional.” As proposed, traditional compounding—as discussed by FDA in testimony at the November 2012 congressional hearings and the December 2012 stakeholder meetings—would remain under state jurisdiction. Nontraditional compounding would be subject to federal standards based on higher-risk factors such as the amount of product being made or whether the drug is being dispensed to someone other than the ultimate user.

APhA believes that this tiered regulatory approach “has its merits, generally supports the concept, and is very interested in continuing dialogue with FDA, Congress, States and other stakeholders to explore potential solutions,” according to its January 18, 2013, comment letter to FDA.

The Association recommended considering the following areas for further clarifications and additions:

• Compounding standards: APhA supports efforts to ensure proper resources and funding for state boards of pharmacy for compounding regulatory activity.
• Sterile compounding licensure: APhA supports consideration of enhanced standards and state licensure for sterile compounding to ensure consistent standards across all states and providers in all practice settings.
• Manufacturer versus compounder: APhA agrees with ongoing dialogue that the definition of compounding versus manufacturing needs to be clearly defined.
• Amount/quantity
• Compliance policy guide
• Education and training resources
• Communication
• Accreditation

The Association’s January 18 letter to FDA built on the December 2012 intergovernmental meeting; APhA’s discussions with FDA at the December 2012 pharmacy stakeholders listening session; APhA’s comments to the Senate Health, Education, Labor, and Pension Committee in November 2012; meetings with House Energy & Commerce Committee staff; and APhA’s ongoing dialogue with congressional and agency staff, the pharmacy community, and other stakeholders.

Diana Yap
Source found here

Inspection at Taiwan plant illustrates FDA inspections challenge Facility failed to do in-process testing or keep raw data to validate safety Read more: Inspection at Taiwan plant illustrates FDA inspections challenge - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/inspection-taiwan-plant-illustrates-fda-inspections-challenge/2013-01-29#ixzz2JObx7USd Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

With countries all over the world building up their drugmaking capabilities, the FDA is working to keep up with inspections of existing plants even as more come online. In fact, the FDA says there are now more foreign than U.S. plants that it must keep tabs on. When FDA inspectors do get in them, they often find that facilities that have been exporting products to the U.S. for years are not meeting some of the most basic manufacturing standards.
A warning letter posted today on the FDA website for a operation in Taichung City, Taiwan, illustrates the challenge. Inspectors found that the Beanne Chemical facility failed to validate its manufacturing processes; was not conducting in-process testing, only finished-product testing; and was not testing for stability that would support expiration dates.


Read more: Inspection at Taiwan plant illustrates FDA inspections challenge - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/inspection-taiwan-plant-illustrates-fda-inspections-challenge/2013-01-29#ixzz2JOc53KAG
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Compounder that operated like drug plant paid big bucks to owners

Judge orders NECC shareholders to keep hands off $21 million in payments

Read more: Compounder that operated like drug plant paid big bucks to owners - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/compounder-operated-drug-plant-paid-big-bucks-owners/2013-01-29#ixzz2JOb2bfSn
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Bill would ban basic compounds behind synthetic drugs like bath salts, spice

Tuesday, Jan. 29, 2013By MATTHEW LONGDON
Cronkite News

About HB 2327:

• Author: Rep. Eddie Farnsworth, R-Gilbert.

• Key provision: Would expand the state's definition of dangerous drugs to include chemical configurations that typically compose synthetic cannabinoids and bath salts.

• Status: Endorsed by the House Judiciary Committee and headed to the floor by way of the Rules Committee.

PHOENIX – It’s become a pattern as state lawmakers try to address synthetic drugs such as bath salts or spice: Almost as soon as one recipe is outlawed, manufacturers simply change to a mix that isn’t banned.

Hoping to get ahead of that cycle, the chairman of the House Judiciary Committee is out to ban the basic chemical formulas underlying such drugs.

“Imagine a Christmas tree. You can change one of the bulbs on the lights and it’s a little different, but it’s the same tree,” said Rep. Eddie Farnsworth, R-Gilbert. “This bill would just outlaw the Christmas tree.”

Farnsworth said that chemists have identified the most basic formulas used to create synthetic drugs. HB 2327 would ban those basic formulas so the substances are always illegal despite any alteration.

He said he avoided banning any formula that had a legitimate commercial use, such as the recipes for cleaning supplies.

Continue to read here

Reminder: Iowa Board of Pharmacy Meeting by Teleconference tomorrow at 2:00

Notice of Board Meeting 

January 30, 2013

The Iowa Board of Pharmacy will by teleconference on Wednesday, January 30, 2013, at 2:00 p.m. An in-person meeting is impractical due to travel distances of members of the Board, the limited agenda, and the need for immediate action.

The call will originate from the Board office located at RiverPoint Business Park, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309. The tentative agenda can be found here.

Please note: The Iowa Board of Pharmacy may address agenda items out of sequence to accommodate persons appearing before the Board or to aid in the efficiency of the meeting. Times are subject to change. Please phone the Board office at (515) 281-5944 before January 30, 2013, to confirm times.

Reminder of Louisiana Board of Pharmacy Meeting 1/29/13 at 8:30

Louisiana Board of Pharmacy
3388 Brentwood Drive
Baton Rouge, Louisiana 70809-1700
www.pharmacy.la.gov
NOTICE IS HEREBY GIVEN that a meeting of the Board has been ordered and called for 8:30 a.m. on Tuesday, January 29, 2013 at the Board office, for the purpose to wit:
A G E N D A
NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 01-16-2013
1. Call to Order
2. Invocation & Pledge of Allegiance
3. Quorum Call
4. Consideration of Replacement Emergency Rule re Compounding for Prescriber’s Use
5. Opportunity for Public Comment
6. Announcements
7. Adjourn