Three Compounding Pharmacy Misconceptions, Debunked

In the decades that VLS Pharmacy and New Drug Loft pharmacy have been in business, we have heard our fair share of misconceptions about the work that we do. Below, we explore and debunk three of the most common sentiments we hear regularly from patients and providers alike.

Misconception #1) Compounding pharmacies are out of control like the Wild West and are not safe; they have no supervision or regulatory oversight.

First, when operating properly and compliantly, a compounding pharmacy is a very safe place for producing compounded medication. In fact, compounding is far more common than one might think; hospitals have in-house compounding pharmacies (or frequently use them) so that they can make the necessary adjustments to medications for patients with specific needs including pediatric dosages for chemotherapy or creating IV drugs to serve small patient populations. What we do in our own pharmacies is precisely the same type of work: custom medication compounding by expert, trained, and licensed pharmacists. 

Second, there are governing bodies that oversee all compounding pharmacies and strict safety measures that must be adhered to.  To name just a few:

• We must strictly comply with the comprehensive standards laid out by the United States Pharmacopeial (USP) Convention for sterile and non-sterile compounding, recognized in various provisions of the federal Food, Drug and Cosmetic Act . These USP chapters issue strict standards that apply to compounding that cover details like chemical purity, strength and the quality of medicines that are compounded. 
• VLS Pharmacy is a PCAB accredited pharmacy which means we choose to subject ourselves to one of the most comprehensive compliance bodies for assessing compounding pharmacies based on standards laid out by the USP Convention covering sterile and non-sterile procedures under USP <795> and USP <797>. This includes annual verification and independent on-site surveys and inspections conducted by a third-party individual who reviews all of our compounding processes. 
• As part of the Verified Pharmacy Program (VPP) hosted by the National Boards of Pharmacy (NABP) we are regularly inspected to make sure we are operating in full compliance with state laws and safety standards. This seal of approval is widely recognized nationwide. 
• As a 503A compounding pharmacy, we are subject to inspections by FDA on a regular and unannounced basis. 
• We must source all active pharmaceutical ingredients (APIs) that go into our compounded medications from an FDA-registered facility and each must be accompanied by a valid Certificate of Analysis (COA). 
• For any controlled substances that we compound (including narcotic drugs for anxiety, sleep disorders or pain medications like hydrocodone), we have direct oversight by the Drug Enforcement Administration (DEA).

Finally, there are ways to make sure you are working with a reliable and safe compounding pharmacy:

• Ask questions.  Safety and quality are (and should be) a pharmacy’s top priority.  Don’t be afraid to ask questions about licensing, certifications and the measures taken to ensure a safe and quality medication. 
• Check to see if a pharmacy has had any warning letters or has received a Form 483 from the FDA. 
• Confirm Credentialing. There are many credentialing bodies and membership organizations that help ensure a compounding pharmacy is reliable, adherent and safe. Check to see if a pharmacy has earned PCAB accreditation or has independently opted into PCCA membership. Both PCAB accreditation and PCCA membership signal that the facility is open to third-party scrutiny and are accessing the best practices and quality pharmaceutical ingredients in the industry. You can look up PCCA Pharmacy members using this directory tool: http://www.pccarx.com/Resources/FindACompounder

Misconception #2) Compounding pharmacies do not use precise technology to create medicine; it’s back-room chemistry with a mortar and pestle.

Many patients and prescribers envision a compounding pharmacy as it was at the turn of the century and into the 1940s and 50s. At that time, every pharmacy was compounding (there were no commercial pharmaceutical companies as there are today) and medications were administered by a local pharmacist wielding a mortar and pestle at the pharmacy on Main Street, USA. Today, compounding looks very different. 

At VLS Pharmacy, where we compound sterile medications like intravenous, intramuscular, subcutaneous and ophthalmic drugs, we boast state-of-the-art, innovative facilities that are environmentally monitored 24/hours a day very much like a large pharmaceutical company. In addition, we have designated clean rooms and USP <797> sterile rooms, one which is segregated for compounding hazardous drugs. All of the sterile compounding staff are trained by the Professional Compounding Centers of America (PCCA) to work in sterile compounding. Have a look inside our facility with this online tour.  Further, we have been compliant with all USP <800> guidelines for handling hazardous drugs since 2015, even before they were revised in 2019.  

Misconception #3) Compounding pharmacies are all the same. 

All compounding pharmacies create custom medications, but in what context, and for how many people? That can depend on their designation. There are two FDA designations assigned to facilities that compound medications: 503A and 503B. VLS Pharmacy and New Drug Loft are designated as 503A pharmacies which means that they may only compound medications upon receipt of patient-specific prescriptions approved by the prescribing practitioner. 503B outsourcing facilities, however, operate very differently and produce large batches of medication at a single time.

For more information about how we operate as a 503A pharmacy, and what makes our pharmacies stand out, please contact our team: info@vlspharmacy.com