Understanding the Basics of Pharmaceutical Compounding

What Is Pharmaceutical Compounding?

According to the FDA, human pharmaceutical compounding is a common practice involving a licensed pharmacist, licensed physician, or an individual supervised by a licensed pharmacist in the case of an outsourcing facility. This process entails combining, mixing, or modifying drug ingredients to produce a customized medication designed for an individual patient.

Also, this practice is essential when commercial pharmaceuticals do not adequately address individual needs, such as when a patient requires a different dosage form, a specific combination of ingredients, or the removal of certain allergens.

For instance, pharmaceutical compounders can produce liquid formulations for patients who struggle with swallowing pills, combine medications for easier administration in emergency trauma care, and dilute drugs to unique strengths not offered by commercial manufacturers.

In the healthcare industry, pharmaceutical compounding plays a vital role in numerous scenarios:

• Access to specialized medications unavailable commercially or discontinued
• Tailoring formulations for swallowing difficulties, allergies, and better tolerability
• Meeting medication needs of children and elderly with appropriate strengths and flavors
• Consolidating multiple medications into one for simpler treatment and better adherence
• Managing allergies and sensitivities by excluding allergens, dyes, or preservatives for safety
• Customized medications for individual needs, including dosages, forms, and allergen exclusions

While compounded drugs can address crucial medical requirements for certain patients, they also pose a risk to patients' well-being. The FDA's compounding program strives to safeguard patients by preventing the use of unsafe, ineffective, and substandard compounded drugs. At the same time, it ensures that patients who genuinely require lawfully-marketed compounded drugs can access them.

Pharmaceutical Compounding vs Drug Manufacturing

Compounding in its traditional form involves the customization of a medication to fulfill the precise requirements outlined by the prescriber. It is then dispensed directly to the patient, following a legitimate prescription specifically for that individual. A pharmacist licensed by a state board of pharmacy undertakes or oversees the process of pharmaceutical compounding.

It is worth noting the distinction between the legal oversight of compounding and manufacturing: manufacturing refers to the large-scale production of FDA-approved drug products that are subsequently sold to authorized entities, such as pharmacies, healthcare practitioners, and others permitted by state and federal regulations to distribute them.

Benefits of Pharmaceutical Compounding

Pharmaceutical compounding offers numerous benefits:

• Customized medications tailored to individual patient needs
• Avoidance of allergens or sensitivities by removing specific ingredients
• Precise dosing for pediatric and geriatric patients
• Access to discontinued or unavailable medications
• Alternative delivery methods for improved absorption and convenience
• Flavoring options for better medication acceptance
• Combination therapy by blending multiple medications into a single formulation

Pharmaceutical compounding allows healthcare professionals to provide personalized treatment options while considering factors such as allergies, dosage preferences, and pediatric or geriatric considerations. Additionally, compounded medications can be formulated in various dosage forms — including creams, gels, capsules, suppositories, oral solutions, and transdermal patches.

Risks of Compounded Drugs

Both consumers and healthcare professionals depend on the drug approval process to ensure that medications are safe, effective, and high-quality. However, compounded drugs do not undergo the same FDA assessment of manufacturing quality before being marketed, meaning the safety and effectiveness of these formulations are not verified.

Because compounded drugs — while potentially meeting important medical needs — lack the same safety and quality assurances as approved drugs, using compounded drugs without necessity exposes patients to serious health risks. The FDA does not verify the safety, effectiveness, or quality of compounded drugs before they enter the market, making them prone to problems like contamination or excessive active ingredients, which can lead to severe harm or even death.

Inspections of compounding facilities have revealed concerning conditions, including unsuitable sterilization methods, unhygienic practices near compounding areas, and operators handling sterile drugs without proper protection. Compounding drugs under unsanitary conditions can result in widespread patient harm, particularly when large-scale, non-patient-specific compounding and distribution occur. Identifying such compounders can be challenging for the FDA, and some states may need more resources for oversight.

In October 2012, the US experienced a multistate fungal meningitis outbreak and other infections caused by contaminated compounded drugs from the New England Compounding Center in Framingham, Massachusetts. These contaminated drugs were distributed nationwide and administered via injections into patients' spines and joints. The outbreak resulted in over 750 infections and more than 60 deaths, affecting approximately 14,000 patients.

Stages of Pharmaceutical Compounding

The compounding process typically involves three main stages: (1) formulation, (2) preparation, and (3) quality control.

Formulation

The formulation stage requires the pharmacist or compounding specialist to work closely with the prescribing physician to determine the most appropriate ingredients and dosage form for the patient.

Preparation

Once the formulation is established, the compounding specialist prepares the medication using precise measurements and techniques.

Quality Control

Finally, the compounded medication undergoes rigorous quality control procedures to ensure its safety, potency, and stability. While pharmaceutical compounding offers valuable benefits, it is important to ensure safety and regulatory compliance.

Regulatory bodies, like the US FDA, provide guidelines to ensure that compounded medications meet specific quality standards. These guidelines include good manufacturing practices (GMPs) and strict quality control protocols.

Additionally, compounding pharmacies should prioritize sterile compounding practices to prevent contamination and maintain patient safety. Sterile compounding involves the preparation of medications in a sterile environment to minimize the risk of infections and ensure the integrity of the compounded product. Sterile compounding guidelines address air quality, cleaning and disinfection procedures, personnel training, and equipment validation.

What Is a Compounding Pharmacy?

A compounding pharmacy is a specialized type of pharmacy that focuses on the practice of pharmaceutical compounding. These pharmacies prepare personalized medications by combining specific ingredients in unique formulations to address the specific requirements of individual patients. Such medications are often not commercially available or require modifications due to allergies, dosage adjustments, or specific delivery methods.

The regulation of compounding pharmacies can vary depending on the country and jurisdiction. In the US, compounding pharmacies primarily fall under the oversight of state boards of pharmacy, which establish standards and guidelines for compounding practices within their respective states. These boards are responsible for implementing regulations that ensure the safety, quality, and appropriate labeling of compounded medications.

Compounding pharmacies in the US are subject to the regulatory authority of the FDA. The FDA's role involves verifying that compounded medications comply with applicable laws and regulations, focusing on safety, effectiveness, and quality. The FDA also has the authority to conduct inspections of compounding pharmacies, issue warning letters or recalls, and take enforcement actions when necessary.

Recognizing that the regulatory framework surrounding compounding pharmacies can evolve and undergo changes over time is crucial. Therefore, it is always advisable to consult the specific regulations and guidelines of the relevant authorities in a particular jurisdiction.

Recent Advances in Pharmaceutical Compounding

In recent years, advancements in technology and research have further improved the field of pharmaceutical compounding. Compounding pharmacies now have access to cutting-edge equipment, quality control methods, and specialized training programs for compounding professionals, and these advancements contribute to enhanced precision, accuracy, and safety.

For example, compounding centers use many new advancements, such as 3D printing technology, technology-assisted workflow systems, computer-aided designing, semi-automated compounding systems, and other robotics.

The growing demand for personalized medicine and the need to address patients' unique requirements continue to drive the importance of pharmaceutical compounding. By working closely with healthcare professionals, compounding pharmacists and specialists can provide tailored solutions that cater to individual patients, ultimately improving treatment outcomes and patient satisfaction.