Compounded medications have many advantages, but one aspect we get asked about is why compounds have a seemingly short Beyond-Use Date (BUD). This article aims to shed light on why BUDs are relatively brief in the realm of compounded medications.
What is a BUD?
While manufactured pharmaceuticals are assigned an expiration date, compounded medications are labelled with a beyond-use date. Manufactured drugs are standardised, therefore their standard formulations can go through testing to determine how long the manufacturer can guarantee safety or potency.
When a pharmacy compounds a medication, it changes based on what is added, what it’s exposed to or how it’s stored. This means the pharmacist assigns each compound a BUD on an individual basis to advise patients of how long the compounded medication can safely be used.
What factors determine the BUD?
There are many factors that go into determining the BUD and this means multiple reasons it’s relatively shorter than the expiry dates patients are accustomed to seeing on manufactured medications.
- Each compound is unique: Compounded medications are crafted on a patient-by-patient basis, making each formulation unique. The variability in formulations make it challenging to conduct the same stability testing that goes into manufactured drugs. The resulting lack of comprehensive data means a more cautious approach with shorter BUDs is necessary to avoid potential risks associated with chemical or physical instability.
- Patient safety: Unique formulations mean that each compound has different risks associated. Pharmacists’ number one priority is ensuring their patients are safe. The shorter BUDs are a proactive measure to ensure that patients receive medications at their peak potency, reducing the likelihood of compromised efficacy or adverse effects.
- Regulations: Pharmacists in Ontario take into account regulations from Health Canada, Ontario College of Pharmacists (OCP), and the National Association of Pharmacy Regulatory Authorities (NAPRA). Both of these regulatory bodies put patient safety at the forefront, providing another layer of protection to the public. Following these regulations means that there cannot be compromise when it comes to assigning a BUD in most cases.
- Storage Considerations: Compounded medications are created on a case-by-case basis and then sent home with patients. Once they leave the pharmacy, the final compounded product is subject to much more variability in how it is stored when compared to a commercially sealed, packaged and mass-produced drug. Differences in light, temperature and humidity found in homes can affect the stability of the medication. Because compounded drugs also do not contain the same preservatives as those that are mass-manufactured, there is more chance for contamination or instability. A shorter BUD ensures that patients know when their medication is safe and effective even under less optimal storage.
While maybe not always convenient, you can trust that BUDs are a necessary safeguard for patients. Pharmacists play a key role in adhering to these standards to provide patients with high-quality, personalized medications while prioritizing their safety. If you have questions about the dates on your specific medication, reach out to one of our pharmacists!