Ask the average compounding pharmacist what the USP <795> general guidelines state about stability and beyond use date (BUD) and they can pretty clearly explain it; for compounded formulations without stability information they can assign a BUD up to 30 days for water containing topical formulations, 14 days at cold temperature storage for water containing oral formulations, and 6 months for non-aqueous formulations.
Unfortunately, the reality of how each pharmacy currently assigns BUDs for their formulations does not match their rhetoric. Further, the reality of how each pharmacy board inspector understands these guidelines or even begins to enforce these guidelines is unclear and inconsistent. Even further, the reality of how each accrediting organization inspector enforces these guidelines varies based on the inspector’s individual qualities and discretion.
To take it a step further, here is the pertinent section from California pharmacy law, Article 4.5 section 1735.2(h):
“Every compounded drug product shall be given an expiration date representing the date beyond which, in the professional judgment of the pharmacist performing or supervising the compounding, it should not be used. This “beyond use date” of the compounded drug product shall not exceed 180 days from preparation or the shortest expiration date of any component in the compounded drug product, unless a longer date is supported by stability studies of finished drugs or compounded drug products using the same components and packaging. Shorter dating than set forth in this subsection may be used if it is deemed appropriate in the professional judgment of the responsible pharmacist.”
All throughout the country, California included, many compounding pharmacies are opening up based on the financial opportunities and unfortunately their pharmacists in charge are often not capable of determining a BUD by “professional judgment” as stated in the law. But even well established and experienced compounding pharmacies do not have the capability to make these determinations based on the law and the current guidelines. This forces law and guideline abiding pharmacies to put forth thousands of dollars to validate the BUDs for their compounded products.
But wait… isn’t there any easy way out of this? Many pharmacy owners think there is.
It is very common for a pharmacy owner to tell me something like, “We get our BUDs from our wholesaler who provides the formula and the BUD, and we use that as documentation.”
And let the debate begin… and then the anger… and then the frustration with having to comply with these standards. First, I urge them to contact the wholesaler who provides them with the formula and ask for any credible documentation for the BUD and also any packaging information for the BUD studies so they can reasonably apply the BUD to their product. Unfortunately, most of the provided formulas do not have the support necessary to use to truly comply with the law and standards, so this road leads us right back where we started. The pharmacy cannot comply with the USP 795 guidelines without spending thousands of dollars.
So why is this discussion important when a large portion of the industry has been getting by for many years with using BUDs that clearly do not comply with USP 795? The answer is simple, PCAB accreditation. PCAB’s compounding industry influence goes well beyond just their accredited pharmacies.
PCAB has been extremely successful in bringing these standards to the table and it has been the most successful organization at integrating USP into community compounding practices. Pharmacies understand that to be PCAB accredited they will have to take clear steps to abide by USP, including the USP 795 BUD general guidelines.
Unfortunately, these BUD guidelines are one of the most critical barriers preventing the majority of the industry from attempting PCAB accreditation. Many compounding pharmacies are motivated and driven to move their pharmacy towards USP compliance in policies and procedures, training, cleaning and almost all other standards, but the financial burden required to implement the BUD guidelines is prohibitive.
The industry is brought to a halt in progress by this cost restriction and it leaves me pondering a couple of key questions:
1) If these guidelines are considered enforceable standards, then how come only certain pharmacies are truly complying with them?
2) And is it fair that many pharmacies spend thousands of dollars annually on stability indicating studies while their competitors spend nothing and just assume a longer BUD with no regard for USP?
As part of our ITL Consulting True Quality Partners program, there is a strong focus on ongoing compliance, quality assurance, and finding the optimal ways to approach these BUD guidelines and each pharmacy’s state specific laws. We also provide guidance to pharmacy's considering PCAB accreditation and if it is right for their practice.
Please contact us with your interest in having a free consultation with our pharmacists regarding these guidelines and your practice.