For centuries, physicians have prescribed medications for their patients. The pharmacist followed exactly the physician's specifications and meticulously formulated these prescriptions. As the science of medicine advanced, many of the standard prescriptions began to be formulated and manufactured by pharmaceutical manufacturers. Most phamacists welcomed the change, since this removed most of their physical hand labor. Now phamacists could concentrate on spending more time with the patients and the dispensing and counseling process.
However, physicians began to notice that not all patients responded to the standardized manufactured medicines. There was still a need to formulate or "compound" prescriptions to the individual needs of these patients. Many patients were sensitive to the various fillers, dyes and preservatives that were used in commercial medicines. A few pharmacists responded to theses special needs by continuing to carefully compound these prescriptions to the exact specifications ordered by the physician without the offending chemicals. Some medications have been discontinued by the manufacturers simply because it became unprofitable to manufacture them. This became a real problem for the patient who had responded well to these drugs. Where could this person obtain their needed medication? Again, the compounding pharmacist is usually able to meet this need.
The compounding pharmacist who is committed to the art and skill of prescription compounding has made a significant investment in obtaining pure drugs and chemicals along with highly specialized equipment in order to make these medications. The compounding pharmacist must be involved in obtaining extra education and training which is unique in the profession of pharmacy. Compounding laboratories and sterile environments are all part of the compounding pharmacy. Literature to verify and validate the use of unique compounded medications must be researched and distributed to the physicians who choose to treat the unique needs of their patients.
Frequently Asked Questions about Compounding
(This comes from the International Academy of Compounding Pharmacists (IACP) www.iacprx.org)
What is pharmacy compounding?
In general, pharmacy compounding is the customized preparation of a medicine that is not otherwise commercially available. These medications are prescribed by a physician, veterinarian, or other prescribing practitioner, and compounded by a state-licensed pharmacist. A growing number of people and animals have unique health needs that off-the-shelf, one- size-fits-all prescription medicines cannot meet. For them, customized medications are the only way to better health.
Who are compounding pharmacists?
Pharmacy compounding is a centuries-old, well-regulated and common practice. Pharmacists are some of the most respected and trusted professionals in the United States. In a recent survey, pharmacists ranked second (only behind nurses) as the most trusted professionals in American society. Compounding has evolved into a specialty practice within the pharmacy community today. New applications to meet today’s patient needs require additional education, equipment, and processes that not all pharmacies possess.
How are compounding pharmacies and pharmacists regulated? Should there be increased federal oversight?
All pharmacies and pharmacists are licensed and strictly regulated at the state level. Compounding is a core component of pharmacy and has always been regulated by state boards, which are constantly updating their standards and regulations. In addition, standards set by the United States Pharmacopeia (USP) are integrated into the practice of pharmacy compounding. The Pharmacy Compounding Accreditation Board (PCAB) has developed national standards to accredit pharmacies that perform a significant amount of compounding.
Does the FDA have the expertise and federal power to regulate compounding pharmacies? Why shouldn’t compounded medications, especially the most commonly used combinations, have to go through FDA’s established drug approval process?
The medical profession, including the practice of pharmacy, has always been regulated by the states. State boards of pharmacy are in the best position to inspect pharmacy operations, develop appropriate regulations, and respond to problems or violations. The FDA does have an important role to play in making sure that ingredients used in compounding are safe and are manufactured by the FDA-registered and inspected facilities, but there is no such thing as an “FDA-approved” pharmacy.
The FDA’s drug approval process takes years and can cost hundreds of millions of dollars. Requiring this for individually personalized medications that fulfill an individual doctor’s prescription is both impractical and contrary to the best interests of patients requiring immediate treatment.
What suppliers sell ingredients to compounding pharmacies? How are these suppliers regulated?
Just like big pharmaceutical manufacturing companies, compounding pharmacies get their ingredients for medications from the suppliers that are registered and inspected by the FDA. Foreign suppliers are FDA- registered facilities.
There are thousands of FDA-approved drugs on the market for just about any ailment. Why do we still need compounded medications?
Some valuable medications and their different delivery methods are only available by compounding. Restricting a doctor’s access to compounded medications would be a serious mistake. Moreover, because of the economics of pharmaceutical manufacturing, FDA-approved drugs that serve a limited population are often discontinued by manufacturers. In most of these cases the only option left for doctors and their patients is to have a compounding pharmacist make the discontinued drug from scratch using pharmaceutical grade ingredients.
Are compounded medications safe? How does one know that the compounded medication they are taking is safe and effective?
Compounded medications are similar to the so-called off-label use of FDA-approved drugs. When the FDA approves a specific drug as safe and effective, this determination applies only to the specific disease or condition for which the drug was tested. But physicians and veterinarians often prescribe medications for treatments for which they have not been specifically approved. Medical professionals do this because, in their judgment, the treatment is in the best interest of the individual patient.
Similarly, medical professionals often prescribe compounded medications because they believe it is the best medical option for their patients. It is estimated that one fifth of all prescriptions written for FDA-approved drugs are for uses for which they were not specifically approved.
Compounding Pharmacy :
There are compounding pharmacies in most large cities in the United States. However, not all are the same when it comes to pricing, customer service, and compliance to sterilization regulations. You should call them to compare prices and to provide your credit card and address information. Prices for testosterone products (creams, injections, pellets), HCG, TRIMIX, clomiphene (Clomid), anastrazole (Arimidex), nandrolone, pain creams, Sermorelin, estrogen/progesterone creams, erectile dysfunction medications in sublingual and other fast acting formulations and other compounded products can vary widely among compounding pharmacies. If your doctor uses only one compounding pharmacy, tell him or her that you will shop around before committing to theirs as the main source of your products.
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