No person is the same as the next. We are all unique and should be treated as such; especially when it comes to medicine. Culture, genetics, allergies, physical limitations, or even personal preference are all reasons why many turn to compounding. Like a fine suit or an elegant dress, medications are best when they are custom-tailored. Otherwise, they’re not a perfect fit. Like tailoring, compounding is an option to make your medication fit the way it should.
A Little History
To better understand compounding and the important role it plays in medicine, we must first understand the history behind it. Records of pharmaceutical formulations reach as far back to 2000 B.C. in Ancient Egypt. These records describe preparations of various solutions and ointments made from the natural products gifted by the Gods. Later in Ancient Greece, a medical renaissance would flourish. Great minds such as Hippocrates would seek reason and rationale behind traditional medicines. Using medical evidence, the Greeks began to formulate medicines base d on science; falling back on theology when medicines failed. Continuing into the 20th century, the majority of medications were hand-crafted by pharmacists for their patients’ specific needs. As the world grew larger, the need for compounding pharmacies became smaller. As the Baby Boomer generation grew, so did the supply for medicines, turning to mass manufacturing of medicines we see today.
Compounding vs Manufacturing
What are the differences between compounding and manufacturing? Both manufacturers and compounding pharmacies must follow strict guidelines which are set by state and federal authorities. The guidelines impose standards for facilities, ingredients, cleaning, and personnel requirements. Manufacturers follow guidelines set by the Food and Drug Administration. This allows them to sell medications distributors who, in turn, sell to pharmacies. While the FDA regulates the ingredients used in compounding, the compounding process and guidelines are overseen by the United States Pharmacopeia (USP) and the State Boards of Pharmacy. The USP is specific to compounding, setting regulations on ingredient standards, compounding practices, and testing requirements. This ensures safe and effective compounded medications are distributed to the public.
Despite the separation of governing organizations, sometimes it may be difficult to distinguish a compounding pharmacy from a manufacturer. A manufacturer produces medications in mass quantities. These are then sold to pharmacies, healthcare practitioners or others who are authorized to sell them. Traditional compounding is the preparation of a medication to meet the prescriber’s exact specifications to be dispensed to a particular patient.
Accreditation: Going the Extra Mile to Ensure Quality
To further ensure compounded medications are safe and effective, compounding pharmacies can gain special accreditation from various organizations. Optional accreditations, like the Pharmacy Compounding Accreditation Board (PCAB) Accreditation from the Accreditation Commission for Health Care (ACHC), are symbols of quality in the pharmaceutical industry. Pharmacies that obtain these accreditations must undergo a rigid application process that evaluates the pharmacy’s processes, documentation, rules, and regulations under the highest standards. These standards are stricter than the requirements of state boards of pharmacies. Pharmacies must continue to maintain their standards of quality and ongoing compliance to maintain their status.
Today compounded medicines account for approximately 3% of all medications sold in the US. While compounding seemingly plays a very small role in modern medicine, it is still a vital need for many patients. Is compounding right for you? That is a question that may not be answered easily. If you have ever had a poor medication experience, consider speaking to your doctor about compounding as an alternative.
Who benefits from compounding?
The main advantage of compounding is to provide patient-specific formulations when mass-produced medications aren’t right for the patient. Compounding provides an outlet to make your medication truly your own. They are ideal when:
- a patient has an allergy or needs a medication made without certain dyes or preservatives,
- a patient can’t swallow a pill and prefers a liquid, lozenge or rapid-dissolve tablet,
- a medication is on back order,
- a patient needs a dosage that is not commercially available and wants to avoid measuring doses or cutting pills (perfect for children), or
- adding flavor will encourage dosage compliance by a pediatric patient.
The possibilities are endless! We work with you and your doctor to find the most effective treatment option and customize it for you.
Additional Resources
Drug Applications and Current Good Manufacturing Practice Regulations, U.S. Food & Drug Administration
https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm090016.htm
FDA Implementation of the Compounding Quality Act, U.S. Food & Drug Administration
https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm375804.htm
USP Compounding Standards, United States Pharmacopeia
http://www.usp.org/usp-healthcare-professionals/compounding
We Are a PCAB Accredited™ Compounding Pharmacy – Why That Matters, Coastal Pharmacy & Wellness
https://www.coastalpharmacyandwellness.com/what-we-do/compounding-pharmacy/coastal-pcab-accredited-pharmacy-matters
About the Author
Dylan Lim, PharmD Candidate 2018
