All FAQ Questions
The increasing FDA influence is forcing an increase in standards of sterile compounding operations. By working in conjunction with USP on revising section 795, 797, and 800, and with State Boards of Pharmacy on audit compliance standards and the draft MOU over reporting adverse events in the 503A settings, the FDA is surrounding the entire sterile compounding setting. Hospital pharmacy leaders should be attuned to the fact the FDA is a big influencer and hospitals should look for the common threads in emerging draft guidelines as a clear direction of where future standards and regulations are heading.
Hospitals and health systems really need to understand what their own needs are now, and how those needs might evolve as their own business plan evolves. When they consider partnering with a 503B, they should do so with one that can address their current needs and their longer term needs as well. It’s important for them to understand how well a 503B is positioned for the longer term to meet the regulatory changes occurring within the 503B space. QuVa has developed an evaluation checklist for hospitals and health systems (see our “facilities” page for a download) that helps them assess potential 503Bs in relation to cGMP knowledge and their compliance status with respect to the FDA. We recommend hospitals use our checklist as a guide, in conjunction with the American Society of Health-System Pharmacists’ checklist, as ours has a more robust cGMP focus.
There’s generally a lot of misconceptions as to how readily available products are to be ordered and shipped. The industry had been spoiled by expectations that were set prior to the New England Compounding Center disaster back in 2012, and for a few years thereafter, when it was very easy for a hospital, at any frequency of ordering and without notice, to place an order and get a compounded preparation made for them same day, and sent to them the next day. The new rules associated with cGMP adherence, and the necessity to do full finished product testing, make that spontaneity impossible in the 503B setting. Same day ordering may very well be possible for highly individualized named patient compounding. However, for commonly used products for general office use there is more onus now on hospitals and health systems to work with their 503B provider in projecting their needs so products can be produced in anticipation of orders arriving.
One thing that hospitals and health systems should do is engage more with 503B providers than undertake it all themselves. Find a 503B provider in good standing with the regulatory authorities and look to see how the hospital can have that 503B provider as an extension of their own pharmacy. By shifting volume and hence production risk out of their pharmacy, it actually does raise the efficiency and quality of their pharmacy operations while reducing the complexity of having to do everything themselves.
There are many benefits – improved quality control, reduced regulatory risk and improved compliance, longer Beyond Use Dating (BUD) that can provide flexibility to the pharmacy and reduce waste, better patient care through labeling that can reduce medication errors, and operational efficiencies. Healthcare providers take advantage of ready-to-administer medicines, produced and fully tested in a controlled environment, to reduce the risk of inadvertent errors that may occur preparing the medications at the bed side. Outsource compounding is also a vital means by which healthcare providers are reducing costs by eliminating waste and gaining valuable efficiencies that allow pharmacists to be more actively involved in individual patient care than in medicine preparation. Increasing regulation of pharmacy practice also imposes a capital cost on healthcare providers that can be alleviated by using outsourced compounders who have the resources to invest in specialty facilities and operations.
QuVa sees it very much as a partnership. 503Bs don’t need to necessarily solve all of the problems of today but should be able to look ahead and see what the emerging issues and the risks for the coming few years are. We’ve got to work ahead of the risk profile of hospitals and health systems so we’re ready to meet those needs when they come to fruition. I think the future benefit will come from us being a part of the partnership so hospitals and health systems can look toward us and figure out how to fit us into their overall initiatives when they’re laying out their own strategic plans. We need to move from being a transactional partner to a strategic one.
The role of the pharmacist in the hospital setting has certainly been elevated to being integrally involved in clinical outcomes. The recognition of the value of the pharmacist as an informed advisor on patient treatment regimens has increased demand for them to be more active at a patient level. Outsourced compounding activities to QuVa assist the pharmacist by freeing up time that may otherwise be spent producing in the hospital pharmacy products that can readily be anticipated and purchased externally.
The necessity to test products fully before release certainly complicates having products ready on a timely basis as that testing process can take on average 14 – 18 days. However, QuVa overcomes this by coordinating anticipated needs with healthcare providers so products can be produced and tested in anticipation of receiving an order. Where the ordering and production requirements are communicated in partnership with our customers, QuVa can supply products within 48 hours including a certificate of analysis in support of the testing of the product.
There are a variety of medicines that can be outsourced to QuVa for supply to the hospital market. The common categories are Labor and Delivery, Anti-infectives, Anesthesiology and Pain Management, OR syringes, and items for general medicine use. Some of the most requested medications are Morphine and Fentanyl, Oxytocin, Norepinephrine, Epinephrine, Ephedrine, Vancomycin, Cefazolin, Succinylcholine, Phenylephrine, and Neostigmine. To view a full list of preparations, visit QuVa’s Services page or download a catalog here.
- USP <71> Validated Testing: We test EVERY BATCH, EVERY TIME for sterility and the batch is held for the duration of the test prior to release. Product is never released at risk. Each shipment comes with a Certificate of Analysis that shows the results.
- Method Suitability: Every formulation undergoes method suitability testing using the full USP panel of 6 organisms to ensure the methodology is valid.
- We have Strict Sampling Guidelines Compliant with the USP <71> requirement, the appropriate sample size is collected at multiple points in the production process and is representative of the batch size.
- Endotoxin testing is performed on EVERY BATCH, EVERY TIME and the batch is held for the duration of the test prior to release. Product is never released at risk. Each shipment comes with a Certificate of Analysis that shows the results.
- Endotoxin Limits: these are established for every individual formulation based on the maximum dosage per hour, average patient weight and route of administration in accordance with USP <85>.
- Endotoxin Method Validation: this is performed on every formulation to ensure that interfering factors in the formulation do not inhibit the functionality of the test and cause false negatives and that the sensitivity of the test is maximized.
- Potency testing is done on EVERY BATCH, EVERY TIME and the batch is held for the duration of the test prior to release. Product is never released at risk. Each shipment comes with a Certificate of Analysis that shows the results.
- Potency Range: Potency tested prior to release and expected to meet approved specifications following USP.
- Potency Testing Method: Performed using high performance liquid chromatographic analysis to ensure potency is accurate and precise.
- QuVa has a Comprehensive Stability Program. Each product is assigned a BUD established through a comprehensive stability testing program that meets 503B requirements. QuVa Pharma has established a program to extend BUDs and this is accomplished through the stability program where product is tested to specification over the desired BUD timeline.
- QuVa’s product catalog lists the BUD of each product and over 93% of the products we sell have a 90-day BUD. Our customer research has shown that at least a 60-day BUD is a very desirable benefit.
We see major change in the enforcement of quality expectations by the FDA, and growing confidence by hospitals in the outsource compounding industry. With the passing of the Drug Quality and Security Act (“DQSA”) in 2013, and subsequent release of FDA guidance documents on expectations of current Good Manufacturing Practices (“cGMP”), the FDA has been educating both outsource compounding manufacturers, and the hospitals, on what the minimum standards are that the compounding industry will operate under. In the past 18 months, we have seen the FDA increasingly hold outsource manufacturers accountable to those cGMP standards to ensure the health of patients who are prescribed medications in a hospital setting.
Overall, this has improved the quality of output the industry as a whole produces. We also see hospitals gaining confidence in outsource manufacturers largely as a result of the FDA’s diligence in enforcement. Health systems that undertake 503B activities are also becoming increasingly cognizant of their requirement to demonstrate cGMP compliance. This is prompting some to consider outsourcing as a risk mitigation strategy. From a patient perspective, this approach will lead to better outcomes and improved care.
Hospital pharmacies and certain licensed compounding pharmacies compound patient-specific preparations by individual prescriptions. This is done in instances where a patient may be allergic or intolerant of an ingredient, such as dyes, preservatives or sugars, commonly found in the commercially manufactured form of a medication. Different dosage forms can also be done in this application. For example, if an elderly person or child can’t swallow a pill, the medicine can be compounded into a liquid form or topical gel that can be absorbed into the bloodstream through the skin for a better patient experience.
Because we operate 503B facilities, our focus at QuVa is non-patient specific, meaning we compound medications that hospitals and healthcare facilities can anticipate being used across a broad spectrum of their patient population. Our ability to do this is increasingly important for two key reasons –a greater commitment by healthcare facilities to provide patients with optimum treatment by having the hospital pharmacist more involved in-patient care, and drug shortages