When you hear the term “compounding pharmacy”, you might wonder: What exactly is it – and is it regulated? A compounding pharmacy is a specialized pharmacy that prepares custom-made medications tailored to meet the specific needs of an individual patient. Unlike standard pharmacies that dispense mass-produced, FDA-approved medications, compounding pharmacies mix ingredients to create unique and custom formulations that aren’t commercially available. In this article, we will answer the most common misconceptions surrounding compounding pharmacies.
How Compounding Pharmacies Entered the Market
Before the era of mass-produced medications, every pharmacy was a compounding pharmacy. The roots of pharmacy lie in apothecaries – early medicine-makers who ground herbs, mixed minerals, and brewed tinctures by hand to treat individual patients. As medicine evolved, so did pharmacy practice.
In 1820, the first U.S. Pharmacopoeia (USP) was published, standardizing formulas and ingredients to ensure consistency in the quality of pharmaceuticals. However, by the late 1800s and into the 20th century, pharmaceutical manufacturers began mass-producing drugs. This mass production became the standard, which resulted in a sharp decline of traditional compounding in retail pharmacies. In recent decades, healthcare has shifted toward more personalized treatment, thus resulting in a resurgent demand for customized medications and compounding pharmacies.
Why Compounding Pharmacies Exist
Medications are not one-size-fits-all, and that’s exactly why compounding pharmacies are essential. Every patient is unique, and their health needs vary based on age, allergies, dosage requirements, medical conditions, or even how they metabolize certain ingredients. Commercially available medications often don’t account for these individual differences and that’s where compounding pharmacies step in. Compounding allows pharmacists to tailor medications to meet specific needs.
Benefits of Compounding Pharmacies
Compounding allows pharmacists to tailor medications to meet a patient’s specific needs. For example:
- Allergy – A patient with a specific allergy to a preservative, dye, gluten/lactose/sugar that is contained in a manufactured medication would require the medication to be compounded without that specific allergen.
- Pediatric/geriatric formulations – Manufactured medications are produced in fixed doses and pill sizes. Young children and elderly patients may need more precise doses or struggle with standard pill sizes and need smaller or different dosage forms.
- Alternative forms – Compounding pharmacies can make medications into a wide variety of dosage forms that are not commercially available. Compounding a liquid or suspension is beneficial for medications that are only commercially available as tablets or capsules for patients who have difficulty swallowing or need specific dosing. Topical creams, troches/lozenges, nasal sprays, suppositories, and sterile injections are among other dosage forms compounding pharmacies can create.
- Discontinued/unavailable medications – Compounding pharmacies can also fill in the gaps for commercial products when the commercial product is discontinued or unavailable due to market shortages.
How Compounding Re-entered Modern Medicine
As discussed earlier, compounding pharmacies originated from traditional apothecaries, customizing remedies long before mass-produced medications became the standard. However, mass production doesn’t meet every patient’s needs.
Today, we are witnessing a strong resurgence in the demand for compounding pharmacies. Why? Because patients and providers are seeking more personalized care. From drug shortages and discontinued products to individual allergies or unique dosage requirements, compounding pharmacies are essential to fill critical gaps in modern healthcare and create a more patient-centric world.
Common Misconceptions Surrounding the Compounding Pharmacies
Compounding pharmacies play a vital role in delivering personalized, patient-centered care, but they are often surrounded by confusion and misinformation. Here we will break down the most common misconceptions about compounding pharmacies, clarify the facts, and help you feel confident and informed when it comes to your healthcare decisions.
Misconception #1: Compounding Pharmacies Operate in a Gray Zone
It has been said that compounding pharmacies operate in a gray zone because of the regulatory framework surrounding compounding. Compounding is legal and regulated in the United States. Compounding pharmacies must be licensed by the state’s board of pharmacy.
The Legal Framework for Compounding Pharmacies
For MediVera Compounding Pharmacy, this means we are licensed in every state we serve. Additionally, we are subject to inspection from any of these states’ boards of pharmacy, as well as the FDA. Compounding pharmacies must follow strict guidelines set forth by the U.S. Pharmacopeia (USP), including chapters <795> non-sterile compounding, <797> sterile compounding, and <800> handling hazardous drugs.
Why the Gray Area Perception?
This “gray area” perception often stems from misunderstandings about their practices, particularly regarding custom formulations, or from past instances of regulatory breaches by a minority of establishments. These isolated incidents can, unfortunately, cast a shadow of doubt over the entire, largely compliant industry.
Misconception #2: Compounded Medications Aren’t Safe for Usage
Compounded medications are safe for use when prepared correctly by trained professionals in properly regulated facilities. For more than 25 years, Medivera Compounding Pharmacy has been the leader in compounding treatments, exceeding our patients’ and physicians’ expectations for quality and customer care. This isn’t just a standard – it’s our priority.
MediVera Compounding Pharmacy meets the highest industry standards and is proud to be PCAB Accredited in both non-sterile and sterile compounding. The Pharmacy Compounding Accreditation Board (PCAB) is a nationally recognized, independent, non-profit organization that sets rigorous standards for pharmacy compounding. Accreditation through PCAB isn’t required – it’s earned by pharmacies that go above and beyond in their commitment to safety, transparency, and excellence. In addition to our PCAB status, MediVera Compounding Pharmacy conducts routine third-party testing for potency and sterility to verify and ensure that every custom medication created is accurate, effective, and contaminant-free.
The Drug Quality and Security Act (DQSA)
In 2013, the Drug Quality and Security Act was enacted as a federal law that amends the Federal FD&C Act and addresses two main areas: drug compounding and the drug supply chain. Title 1: Compounding Quality Act – establishes a framework for regulating pharmacies that compound drugs, aims to ensure safety and quality of compounded medications, grants the FDA enhanced oversight of compounded medications, requires registrations and reporting for outsourcing facilities, and subjects compounding pharmacies to inspections by the FDA.
Enhanced Inspections
Compounding pharmacies are subject to enhanced inspections to ensure adherence to quality standards. These inspections are conducted by both the state’s board of pharmacy, which licenses and regulates the pharmacies, and the FDA. Compounding pharmacies must diligently follow the rules set out by the U.S. Pharmacopeia (USP), an independent nonprofit organization that collaborates with the FDA to establish and maintain quality standards for medicines.
Misconception #3: Compounded Medications Are Not FDA-Approved
Compounded medications are not individually FDA-approved because they are custom-made formulations for specific patients and situations, whereas the FDA’s drug approval process is designed for mass-produced drugs. However, at MediVera Compounding Pharmacy, the active pharmaceutical ingredients (API) used in compounding formulations are FDA-approved and sourced from FDA-regulated facilities.
Reliable Medications You Can Count On
The FDA has the authority to inspect compounding pharmacies to ensure they comply with certain provisions of the Federal FD&C Act and the DQSA.
Misconception #4: Compounding Is Only for Rare or Specialty Drugs
Many individuals mistakenly believe that compounding pharmacies primarily focus on exotic or hard-to-find medications. It’s a common misconception that limits the perceived utility of compounding to only the most obscure medical situations.
Compounding For All Needs, Big or Small
Compounding medications is not only for rare or special drugs. Compounded medications can be as simple as a filler-free aspirin capsule due to patient-specific allergies or as complex as sterile products for injection, like our Trimix, due to a commercially available product. Compounded medications meet the needs of all patients by providing a wide range of medications in customizable doses, dosage forms, and formulations.
Misconception #5: Compounded Medications Are For Humans Only
Compounded medications are not only for humans. At MediVera Compounding Pharmacy, we serve a wide range of patients, aside from humans, including canine, feline, avian, equine, and amphibian, to name a few.
Serving Both You and Your Pets
Veterinary medicine relies on compounding medications due to the specific needs of animals and the lack of commercially available medications for animals. Compounded medications can be formulated to ensure specific doses for animals of all sizes and increase the ease of administration with different dosage forms, enhanced palatability or flavoring, or combining multiple drugs.
Misconception #6: It’s Such A Hassle to Procure High-Quality Compounded Medications
A common belief exists that obtaining high-quality compounded medications is a complex and burdensome process. This misconception often deters healthcare providers and patients from considering compounding as a viable option for personalized treatment.
Hassle-Free Prescribing
For many patients, it may be a hassle to obtain high-quality compounded medications. At MediVera Compounding Pharmacy, we’ve worked hard to eliminate the frustration. Since 1999, we’ve been delivering high-quality, custom-compounded medications tailored to meet the unique and specific needs of patients, without the hassle.
MediVera Compounding Pharmacy continues to work directly with healthcare providers across the country to ease the burden of obtaining customized medications through our user-friendly and secure prescribing Provider Portal and support from our dedicated customer care team.
How To Choose A Reputable And Regulated Compounding Pharmacy?
There are factors to consider when choosing a reputable and regulated compounding pharmacy to ensure safety, effectiveness, and quality pertaining to customized medication. Is the pharmacy PCAB-accredited? Is the pharmacy following USP compounding standards? Are there reputable healthcare providers who work directly with the pharmacy? Does the pharmacy source API from FDA-regulated facilities? Is the pharmacy licensed by the state board of pharmacy? Are there on-site pharmacists to consult?
At MediVerea Compounding Pharmacy, we proudly check every one of these boxes. We simplify the process for both patients and healthcare providers through a secure Provider Portal, personalized services, and a commitment to exceptional quality in every custom formulation.
Your Health Is Our Priority—Choose MediVera Compounding Pharmacy
Founded in 1999, MediVera Compounding Pharmacy™ has been a leader in custom-compounded medications, setting the standard for quality, compliance, and personalized care. The pharmacy partners with healthcare providers across the country to meet patients’ unique therapeutic needs.
Your questions about compounding pharmacies are now answered! Still have more inquiries or ready to experience our services? Reach out to us today.
