A compounded pharmacy is a specialized medical facility that creates customized medications tailored to the unique needs of an individual patient. Unlike traditional drug manufacturers that produce medications in fixed doses and forms for the mass market, these pharmacies prepare formulations on a patient-by-patient basis. This personalized approach involves altering existing drug products or starting with raw ingredients to create a preparation that meets specific therapeutic requirements prescribed by a physician.
Defining Pharmaceutical Compounding
Pharmaceutical compounding is the practice of combining, mixing, or altering ingredients to prepare a drug product specific to a patient’s prescription. This process is distinct from the role of a traditional pharmacy, which primarily dispenses commercially manufactured drugs that come pre-packaged and standardized from a drug company. The pharmacist in a compounding setting works with active pharmaceutical ingredients (APIs) and inactive excipients to formulate a unique medication. These preparations are always made in response to an individual patient’s prescription, rather than being mass-produced for general sale or distribution.
Why Standard Medications Aren’t Enough
Commercial medications are designed with a “one-size-fits-all” approach, but a significant portion of the population requires alterations to their therapy for various reasons.
Allergies and Intolerances
One common scenario involves patient allergies or intolerances to inactive ingredients found in mass-produced pills. A patient may need a drug free of common fillers, such as lactose, gluten, dyes, or preservatives, all of which can be removed or substituted in a compounded formulation.
Dosage Requirements
Compounding also addresses unique dosage requirements that are not commercially available, which is particularly relevant in pediatric and geriatric care. For example, a child may need an exact fraction of a standard adult-strength tablet, or a patient may require a micro-dose that is not manufactured. The compounding pharmacist can measure and combine ingredients to achieve a precise milligram strength.
Availability and Adherence
A third scenario involves medications that have been discontinued by manufacturers or are experiencing a temporary shortage. If a drug is no longer commercially available but remains the preferred treatment, a compounding pharmacy can often procure the bulk raw ingredients to recreate the medication. Compounding also improves adherence by addressing issues of palatability, such as adding a specific flavor to a liquid suspension to make it more acceptable for children or pets.
Scope of Customization and Delivery Methods
The flexibility of compounding allows pharmacists to change not only the strength and ingredients of a drug but also its physical form and route of administration. A solid oral tablet can be converted into a liquid suspension or a topical cream or gel that allows the medication to be absorbed through the skin. Other specialized forms include suppositories, sublingual troches, or lozenges that dissolve slowly in the mouth.
Non-Sterile vs. Sterile Compounding
Compounding preparations are broadly categorized into non-sterile and sterile types, which dictate the environment and technique used. Non-sterile compounding involves preparations like capsules, oral liquids, and topical products, formulated in a clean, but not aseptic, environment. Sterile compounding is reserved for products that bypass the body’s natural defenses, such as injectable solutions, intravenous (IV) infusions, and ophthalmic (eye) drops. Sterile preparations require a highly controlled environment, often called a clean room, to maintain aseptic conditions and prevent microbial contamination.
Ensuring Safety and Quality Control
While the final compounded preparation is not subject to the extensive clinical trials and pre-market approval process of the Food and Drug Administration (FDA), the ingredients themselves are typically FDA-approved substances. Compounding pharmacies operate under a strict framework of regulatory oversight, primarily carried out by state boards of pharmacy, to ensure the quality and safety of their products.
Quality Standards
State boards require adherence to quality standards established by the United States Pharmacopeia (USP), which publishes detailed guidelines for compounding practices. These guidelines establish minimum standards for facility design, ingredient sourcing, and testing protocols. For example, USP General Chapter <797> specifies the requirements for sterile preparations, and <795> addresses non-sterile preparations.
Facility Types (503A and 503B)
The regulatory structure distinguishes between two types of compounding facilities. A 503A pharmacy compounds medications based on patient-specific prescriptions and is primarily state-regulated. A 503B outsourcing facility can prepare larger batches without a patient-specific prescription for use by healthcare systems. 503B facilities are subject to more comprehensive FDA oversight, including current Good Manufacturing Practices (cGMP) requirements.