Compounding is a useful method for prescribers to tailor medications for individual patients when their needs cannot be met using a commercially available FDA-approved product. Compounding may also be used to help address drug shortages to ensure that prescribers can provide medications to their patients in the absence of a commercially manufactured drug.
In this month’s blog post, we’ll explore exactly how compounding pharmacies can help alleviate drug shortages.
When is compounding appropriate?
When available, clinicians prescribe commercially available drugs from FDA-approved manufacturers. However, if a patient is unable to take a medication in its commercially available form, the prescriber is permitted to prescribe a compounded form of that drug. For example, a prescriber may wish to prescribe a drug that is only sold in tablet form, but the patient has difficulty swallowing. In this case, the prescriber may order a compounded version of the drug in liquid form. This example is one of the exceptions that the FDA provides for compounding.
Compounding is also permitted when a drug shortage occurs, in which the manufacturer is unable to supply the market with enough drugs to satisfy the demand. This deficit may occur for a variety of reasons, including recalls, increased demand, or supply chain disruptions, the latter of which have become increasingly prevalent due to the COVID-19 pandemic. As of writing, the FDA lists 124 drugs that are currently in shortage.
Compounding regulations related to drug shortages
Manufacturers are required to notify the FDA of drug shortages so that the FDA can mitigate needs and overall impact. In this scenario, compounding pharmacies may be called upon to help address shortages of commercially available drugs by sourcing the active pharmaceutical ingredients (API) from a reputable supplier and making formulations of it. However, the FDA has specific guidelines that compounding pharmacies must follow.
If a drug appears on the FDA’s Drug Shortage list, it is no longer considered to be commercially available, which loosens some of the strict regulations listed in section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act. Although the FDA does not directly oversee the production nor guarantee the safety of drugs manufactured in compounding pharmacies, they have provided regulations that compounding pharmacies must follow. For example, compounding must be performed by a licensed pharmacist. They are also licensed in many states and must meet all of the requirements of each state’s board of pharmacy. It is also important that the raw materials be obtained from a reputable source, which may not always be the case. In addition, biologics do not qualify for an exemption under these regulations and cannot be compounded.
503A compounding pharmacies
According to the FDA, 503A compounding pharmacies are empowered to compound medications according to prescriptions from prescribers for an individual patient, provided certain conditions are met that provide exemptions from compounding regulations. As mentioned above, 503A pharmacies can help fill a drug shortage.
Generally, a compounding pharmacy is restricted from producing a copy of a commercially available drug. However, if the drug is listed on the Drug Shortages list, this regulation is relaxed, allowing compounding pharmacies to produce a medication that cannot otherwise be obtained. Some hospitals compound drugs in-house if they have the necessary raw ingredients available for the medication.
Thus, during the shortage of a commercially available drug, compounding pharmacies can step in and begin producing a drug until it becomes available from an FDA-approved manufacturer again. In the absence of a drug shortage or a specific patient’s need, compounding should be avoided, and the FDA-approved commercially available product should be prescribed instead. By partnering with a 503A compounding pharmacy like VLS Pharmacy and New Drug Loft, prescribers can rest assured that their patients will have their necessary medications, especially during drug shortages.
Why choose VLS pharmacy?
As a 503A pharmacy specializing in sterile and non-sterile compounding, we will support you and your patients by creating safe, individualized, and effective pharmaceutical therapies. For men and women at any age, feeling healthy, confident, and comfortable is of the utmost importance. Your patients’ needs will change with each life stage. As such, they require an adaptive and personalized treatment plan. By working with a trusted compounding pharmacy like VLS Pharmacy and New Drug Loft, you are expanding the possibilities for successful and sustainable care.
Three pillars that are key to our success include:
- Highly-Trained Staff: Our staff is highly-trained and provides world-class expertise. We ensure that our pharmacists hold current accreditations and are qualified to create your medications.
- Secure Supply Chain: APIs are sourced from PCCA and have Material Safety Data Sheets and certificates of analysis to ensure their purity and potency levels. Every component is traced to verify that it is never contaminated or compromised throughout the compounding process.
- Quality Assurance: We conduct third-party potency and sterility testing and endotoxin detection.
Our compounding facilities
Our compounding facilities feature state-of-the-art labs equipped for sterile and non-sterile compounding – both at the highest quality standard set by USP. Because of this high level of service, we compound medications for ophthalmic, intravenous, and intramuscular administration.
Our facilities boast:
- USP <797> sterile rooms
- USP <71> and USP <81> compliant for in-house sterility and antimicrobial assay testing
- Cleanroom systems for product protection
- HEPA-filtered airflow ISO Class 5 Laminar flow hoods to preserve uniform airflow, prevent sample contamination, and create a particulate-free work area
- Amber hood workbench technology is uniquely used to compound photosensitive substances including hydroquinone, retinoic acid, methylcobalamin, and more.
We continually go above and beyond state and federal standards to achieve an unprecedented level of quality control. Our lab is constantly monitored for temperature, humidity, and airflow. In short, patient safety is the foundation upon which we are built.
Reach out to our team to learn about best practices and to partner with our experts on custom compounded medications for your patients.
All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.