COMPOUNDING MEDICATIONS
Alot of people ask how we are able to offer the base versions of semaglutide and tirzepatide (since there is currently a nationwide shortage of both medications) and how we are able to provide it at such a reduced price.
We partner with a reputable compounding pharmacy who is able to manufacture these medications for sterile injection. Never heard of a compounding pharmacy?
That’s ok, let us explain!
What is a compounding pharmacy?
While most pharmacies offer some level of compounding, most compounding is done in pharmacies that have made the investment in equipment and training to do so safely and efficiently. 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 the eye, or injection into body tissues or the blood).
All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work. With such tools and through applying their knowledge, all pharmacists routinely prepare nonsterile compounded preparations when requested by prescribers.
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 made in these pharmacies are more likely to include both sterile and nonsterile dosage forms. 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?
The practice of compounding is regulated by state boards of pharmacy. Community and hospital compounding pharmacists are allowed exemptions to the Federal Food, Drug, and Cosmetic Act of 1938 if they comply with the regulations outlined in Section 503A. All pharmacists and pharmacies engaged in compounding are subject to oversight by both federal and state authorities.
Pharmacists engaged in compounding are expected to follow applicable standards and regulations for the types of preparations that are compounded. The FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs, by the FDA) used in compounded preparations.
In addition, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This private, nonprofit organization defines the chemical purity of drugs and also issues practice standards. The USP develops standards for the identity, quality, strength, and purity of medicines, dietary supplements, and food ingredients that may be used in compounding preparations. These standards in particular are relevant to compounding pharmacists.
USP General Chapter <797> is a national standard for the process, testing, and verification of any compounded sterile preparations. It provides guidance on preventing microbial contamination and other variances in compounded sterile preparations, regardless of setting (e.g., hospitals, community pharmacies) or who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others).
USP General Chapter <795> provides similar guidance for nonsterile preparations that are compounded in health care settings. It describes categories of compounding (simple, moderate, complex), defines concepts such as beyond-use date and stability, and provides criteria for compounding pharmacists to follow in preparing various drug preparations.
What are the benefits of using a compounding pharmacy?
It Provides Personalized Medication
Commercialized medicines are produced with a standard dosage. These are very difficult to adjust based on patient needs. By utilizing a compounded form of medication we can adjust to any dosage appropriate for you. This also allows us to add additional medication (Vitamin B12) to help reduce side effects, boost the positive effects and provide other additional beneficial action. Click here to see the benefits of Vitamin B12
It Costs Less
Compounding Pharmacies have access to pure, premium medical-grade chemicals that often have lower costs. This makes compounded medicines less expensive than commercialized drugs.
Independent compounding pharmacies tend to eliminate the use of designer dyes and preservatives patented by drug manufacturing companies. Without the cost of patenting and expensive drug components, compounded medications are significantly cheaper than those available on the market.
Is it legal?
ABSOLUTELY! Our reputation is on the line and patient safety is our #1 priority. For more information on compounding pharmacies click here