Why Compounding is Important.
Pharmacy compounding is a long-established tradition that allows a physician to prescribe a specific medication, prepared by a pharmacist, for a patient’s individual needs. Years ago, compounded medications provided the majority of prescription drug care.
Today, most medications are mass-produced by pharmaceutical manufacturing companies. They aim to treat a specific medical condition for a large number of people. Problems can arise when a patient has a medical condition that can not be treated by one of these mass-produced products, or they might be allergic to a dye or filler in a commercial tablet. Patients may not be able to take the medication if a capsule is too large, or a dose is too high, which is common in pediatric cases. Some patients such as those in hospice may not be able to swallow a medication, so it must be compounded into a different delivery system such as a transdermal cream, a suppository or an injectable. These are the situations in which a compounding pharmacist can play a vital role in helping a prescriber to find an appropriate treatment for each patient.
These Issues May Affect Access to Compounded Medications.
You Have a Voice in This!
The Art and Science of Personalized Medications
Compounded Bioidentical Hormone Replacement Therapy (cBHRT)...
When a medical practitioner determines that a medication needs to be compounded to meet the needs of an individual patient, it is because the practitioner has determined that there is no commercially available, FDA-approved medication to meet that patient’s medical need. The starting point for compounding is the active pharmaceutical ingredient (API), also known as “bulk ingredients.”
About Save My Compounds
Save My Compounds is a grassroots advocacy effort that provides up-to-date information on pharmacy compounding, the laws and regulations that impact compounding, and insight on the current issues that may impact the practice of pharmacy compounding.The goal of Save My Compounds is to protect patient and provider access to compounded medications.
Save My Compounds is supported by individuals, patients, compounding pharmacies and other stakeholders that support the practice of pharmacy compounding for both humans and animals. Supporters of this effort advocate for appropriate regulatory oversight in accordance with local, state and federal laws to ensure patients have continued access to – at times life-saving - compounded medications.
The prohibition of dispensing medication for office use, or the requirement that any pharmacy doing so must be regulated by the FDA against manufacturer-like standards, is most likely the result of misunderstanding this much needed—and in many states explicitly permitted—healthcare practice.
Laws & Regulations
Compounding is a founding principle in the practice of pharmacy and is the art and science of preparing a medication for an individual patient’s needs. Pharmacy compounding has been practiced in the U.S. as early as 1820 when the first United States Pharmacopeia (USP) was published. Since that time, the USP has issued several standards specific to compounding, and those standards have been recognized by the U.S. Food and Drug Administration (FDA) and by more than 85% of the state boards of pharmacy.
The Food & Drug Administration (FDA) commissioned an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study to determine whether women and men need the option for “Compounded Bioidentical Hormone Replacement Therapy” (cBHRT), or whether existing manufactured drugs made by large pharmaceutical companies can meet this demonstrated need. The NASEM Committee recommended that FDA add all compounded hormones to its “Too-Difficult-To-Compound” list.
The Food & Drug Administration (FDA) is supposed to represent and protect the American public. But does FDA’s massive funding from large pharmaceutical manufacturing companies influence the agency to look after the interests of the large drug companies instead? Just follow the money for the answer.