Showing posts with label American Pharmacists Association. Show all posts
Showing posts with label American Pharmacists Association. Show all posts

Tuesday, January 29, 2013

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


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.

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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.

Tuesday, July 31, 2012

APhA Publishes Fourth Edition of The Art, Science and Technology of Pharmaceutical Compounding


July 25, 2012
WASHINGTON, DC – The American Pharmacists Association (APhA) recently published the fourth edition of the leading textbook on pharmaceutical compounding, The Art, Science and Technology of Pharmaceutical Compounding.
The book is geared to both student pharmacists taking laboratory classes and practicing pharmacists. In a logical and progressive format, it presents all the information a student needs to understand the purpose and processes of compounding. It includes the essential information on establishing, equipping and operating a compounding pharmacy. It discusses all aspects of good manufacturing practices for compounded medications and it features quality control measures for all aspects of compounding.
For practitioners who already compound prescription medications, the hardbound book is a ready reference featuring more than 200 sample formulations, including bases, vehicles and ingredient-specific preparations. Each formulation lists the necessary ingredients and gives step-by-step instructions for preparing the product. A new chapter emphasizes the importance of knowing the purity and form of all ingredients to ensure that the proper dose of a compounded product is delivered.
The book is authored by Loyd V. Allen Jr., PhD, Editor in Chief of the International Journal of Pharmaceutical Compounding, Edmond, OK, and Professor Emeritus at the College of Pharmacy, University of Oklahoma, Oklahoma City. Allen has written more than 200 refereed publications and abstracts in the scientific and professional literature. He is a principal author of Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems and he has written a monthly compounding column since 1988 for the trade journal U.S. Pharmacist.
To read remainder of news article and for information on ordering click here.

Monday, July 2, 2012

Role of the pharmacist in preventing distribution of counterfeit meds - American Pharmacists Association

American Pharmacists Association - Article March 24, 2012: - Role of the pharmacist in preventing distribution of counterfeit meds

"Summary: The taskforce recommends that pharmacists (1) purchase medications from known, reliable sources; (2) warn patients of the dangers of purchasing medications over the Internet; (3) confirm with distributors that products were purchased from manufacturers or other reliable sources; (4) monitor counterfeit product alerts; (5) examine products for suspicious appearance; (6) work with the pharmaceutical industry, distributors, and the Food and Drug Administration (FDA) to close gaps in the supply chain, especially for drugs in short supply; (7) use scanning technology in the pharmacy as part of a prescription verification process; (8) educate themselves, coworkers, and patients about the risks of counterfeit medications; and (9) report suspicious medications to FDA, the distributor, and the manufacturer.

Conclusion: The consequence of a patient receiving a counterfeit medication in the United States could be catastrophic, and pharmacists must play an active role in preventing such an event from occurring."

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