Khyati Undavia is a licensed pharmacist and holds the role of pharmacist in charge. Her specialty is compounding medications. Today, she explains what compounded medications are and why they are necessary.
What is Compounding?
Compounding refers to the process of creating customized medications tailored to meet the unique needs of individual patients. When a commercially available product cannot provide the desired therapeutic effect, compounding may be used to prepare medication that is specially formulated and dosed for the patient’s requirements. The U.S. Pharmacopia Convention (USP) defines compounding as the preparation, mixing, assembling, altering, packaging, and labeling of drugs, drug-delivery devices, or devices in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner-patient-pharmacist-compounder relationship in the course of professional practice.
There are two types of compounding: traditional compounding and medically optional compounding. Traditional compounding is used when a patient’s medical needs cannot be met by commercially available products, and the preparation of customized medication is deemed medically necessary. Medically optional compounding, on the other hand, may be undertaken to accommodate a patient’s dietary preferences or to improve the taste of medication.
Compounding can be utilized to prepare medications in various forms, including intravenous, topical, or oral administration. The process of compounding ensures that patients receive medication that is personalized to their unique requirements, thereby promoting optimal therapeutic outcomes.
Why is Compounding Done?
Compounding is done for a variety of reasons, according to Khyati Undavia.
Changing Delivery Method
One reason is to change the delivery method of the medication. For example, a tablet can be converted to liquid if the patient can’t swallow a pill. It can also be changed to a topical cream, which can be absorbed by the skin, rather than ingested. Medications can also be converted to a suppository form.
Allergy or Intolerance to an Ingredient
Another reason for compounding is to address allergies or intolerances to inactive ingredients, which can be removed from the medication. If a patient can’t tolerate an inactive ingredient, compounding can deliver the medication without the ingredient.
Medications often include inactive ingredients to create stability or to create tablets. Inactive ingredients can also be used to change a medication’s color, texture, or flavor. In some cases, particularly pain medication, specific ingredients are used to make the medication tamper resistant.
In some cases, it’s a preference rather than an allergy. Someone who wants to avoid gluten, for example, may request gluten free medication.
Customized Strength or Dosage
Compounding also allows the strength or dosage of the medication to be customized for the individual based on the doctor’s prescription.
Change in Flavor or Texture
Additionally, medications can be compounded to improve their taste and texture, particularly for children or pets who may be unwilling to take medication that tastes bad. While adults may be willing to endure unpleasant medication for the sake of their health, young patients may require a medication that tastes good to ensure compliance.
Compounding vs. Drug Manufacturing
While both compounding and drug manufacturing involve the production of medications, there are significant differences between the two processes. Drug manufacturing refers to the large-scale production of FDA-approved drugs, while compounding is typically done on a smaller, individual basis.
Compounded medications are prepared for individual patients with a valid prescription and are dispensed directly to them. In contrast, manufactured drugs are typically distributed to hospitals, pharmacies, and other healthcare facilities for further distribution to patients.
According to Khyati Undavia, while most pharmacies are equipped to perform basic compounding using tools such as a mortar and pestle for grinding ingredients and graduated cylinders for measuring liquids, only a few specialize in compounding. Pharmacists are trained in making compounds as part of their education, and scales and ointment slabs are used to weigh and mix ingredients. However, of the approximately 56,000 community pharmacies in the U.S., only 7,500 specialize in compounding medications.
Sterile and Non-sterile Compounding
Most pharmacies can perform non-sterile compounding. This typically involves compounding topical creams, suspension liquids, and tablets or capsules.
Sterile compounds are introduced directly into the body. These include eye drops, injectable medications, and IV infusions. Sterile preparations require a higher level of expertise and knowledge than non-sterile compounds.
Compounding Pharmacy Oversight and Regulations
The Food and Drug Administration (FDA) is responsible for regulating the safety and efficacy of food and drugs in the United States. Before prescription drugs can be marketed, the FDA must approve their manufacture. The FDA evaluates medications for their quality, safety, and effectiveness.
However, most compounding pharmacies are exempt from FDA regulations. While the FDA oversees the active ingredients used in compounded medications, they do not oversee the compounded preparation itself. The Drug Enforcement Administration (DEA) also provides oversight for compounded medications that contain controlled substances. State authorities are responsible for overseeing compounding pharmacies as well.
To ensure high-quality standards for compounding, the United States Pharmacopeia (USP), a private not-for-profit organization, issues standards for compounding. These standards apply to medications, dietary supplements, herbs, and food ingredients commonly used for compounding.
Compounding pharmacies may also seek accreditation through the Pharmacy Compounding Accreditation Board (PCAB). While this accreditation is not required, it reflects a commitment to high-quality standards and quality assurance.
Compounding Pharmacist Training
Pharmacists are trained in compounding during pharmacy school. Most states require a pharmacist to pass tests on compounding before receiving their license.
However, pharmacies that specialize in compounding can seek additional education. There are no state or federal regulations that require additional training.
Active pharmaceutical ingredient, or API, manufacturers typically offer compounding training.
Compounding Pharmacy Benefits
Depending on your specific needs, there are multiple advantages to selecting a compounding pharmacy. These types of pharmacies prioritize individuals, collaborating with both doctors and patients to create personalized medications.
In some cases, a doctor may prescribe a medication dose that is not available through the manufacturer. Alternatively, a patient may require a different route of administration or a modification of an inactive ingredient due to allergies or other sensitivities.
By working with a compounding pharmacy, patients can receive the precise medication that meets their unique requirements in a timely manner. Rather than simply dispensing standard medications, compounding pharmacies offer a tailored approach that can result in improved outcomes and a better overall healthcare experience.
Drugs That are Commonly Compounded
Many medications can be compounded, but certain types are compounded more frequently than others. Pain medications, particularly opiates, are commonly compounded, as the pharmacist may adjust the medication’s strength or provide it in a non-standard form, such as liquid or lollipops, to suit the patient’s needs. Hormone replacement therapy (HRT) medications are also frequently compounded because the dosage is personalized to the individual patient. Transdermal creams are a common type of HRT medication that is compounded in pharmacies. Additionally, dermatology medications are regularly compounded to customize the medication to the patient’s specific skin type and dermatological requirements.
Khyati Undavia, originally from Bombay, India, developed a passion for life, art, and her cultural heritage, earning several accolades for her dancing skills. At the age of 15, she moved to the United States.
After earning her B.S. in pharmacy and completing her residency, Undavia worked at Medco before taking a bold risk on a struggling pharmacy. Undavia seized the opportunity to purchase the business, using her expertise to transform it into a thriving enterprise. Her efforts paid off, and she succeeded in building a successful pharmacy from the ground up.