EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS

503B HUMAN DRUG OUTSOURCING

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JCB Labs Blog

Compounded Sterile Products-Higher Standards and Increased Patient Safety

Posted By Greg Rockers on Tue, Feb 24, 2015 @ 09:02 AM

In the world of sterile compounding, much has changed over the last two years.  Prior to the passage of the Drug Quality and Security Act (DQSA) in November 2013, USP 797 was the quality standard for compounded sterile products (CSPs).  Now that the DQSA has passed, providers have the option of getting their CSPs from 503B Outsourcing Facilities (OF) that must follow current Good Manufacturing Processes (cGMP).   This significantly higher cGMP standard is preferred among physicians, pharmacists and nurses who want to make sure they give their patients CSPs of the highest possible quality.  In fact, both the FDA and CMS have stated their preference that providers purchase CSPs only from FDA registered 503B Outsourcing Facilities. 

 One significant change that is a result of becoming a 503B Outsourcing Facility is the CSP testing requirements. The requirements are so much more than simply sterility, endotoxin and potency testing. The level of rigor, suitability and specificity is significantly higher. The sterility test must comply with United States Pharmacopeia (USP) 71, the endotoxin test must comply with USP 85 and the potency tests must be based on the compendial method described in the products’ USP monograph.   Make sure your CSP provider is performing these tests at the required level and make sure you ask your Outsourcing Facility for these test results!

 As a consequence of the cost and lengthy time requirements of this level of testing, the days of compounding sterile products one, two or even fifty at a time are over.  To maximize efficiency, control costs and ensure consistent, high-quality products, Outsourcing Facilities must produce their products in larger batches.  JCB Laboratories’ has decreased its’ formulary of products and invested considerable time and resources into manufacturing processes to make sure all products meet the highest standard.  That is the JCB commitment to your patients and that is what I call value!

 While, in rare cases, this may mean the product you used to get from JCB is no longer available, it certainly does not mean we are not innovating, researching and compounding new products. We have been and always will be a dependable, reliable source for innovative new compounds and for drug shortage products.  As you go to conferences and learn about new CSP options or when a drug shortage has an adverse effect on your ability to take care of patients, let us know. We welcome the opportunity to compound CSPs that you need the most.

Your Partner,

 

Greg Rockers. R.Ph.

VP-Business Development

Tag: Sterile Compounding, USP 797, Quality, Partnership, 503B, compounding, outsourcing facility, FDA, cGMP, CMS, DQSA, innovating,

FDA and State Registration for Outsourcing Facilities

Posted By Brian Williamson on Fri, May 16, 2014 @ 11:05 AM

The passing of the Drug Quality and Security Act (DQSA) in November of 2013 was one of the most significant events in the compounding industry in decades.  The DQSA came to fruition after many months of debate and controversy over who had authority and jurisdiction over sterile compounding pharmacies. The result was that a sterile compounding pharmacy could voluntarily register with the FDA as a 503B Outsourcing Facility.  According to the DQSA, this type of registration allows a sterile compounding pharmacy to ship products via interstate commerce without the need for specific patient prescriptions.  However, it does place the pharmacy squarely under the jurisdiction of the FDA and subjects the facility to current Good Manufacturing Practices (cGMP).  cGMP are the regulations that large pharmaceutical manufacturing firms must adhere to in their daily practices.  Complying with cGMP can be a daunting task and not every sterile compounder will elect to register as an Outsourcing Facility.  

In reality, after 6 months under the DQSA, very little has changed. There are still many things evolving regarding federal and state enforcement of the Act.  It will likely take several more months to determine how the FDA and State Boards of Pharmacy will work together to enforce compliance.  It is clear that many State Boards of Pharmacy will require registered Outsourcing Facilities to register in their state as either drug distributors, wholesalers, manufacturers or, in some cases, all three!  In addition, some states are requiring that Outsourcing Facilities have a pharmacy license in their state, while the DQSA stated that an Outsourcing Facility didn’t even have to be a pharmacy?!  

What is not clear is whether the FDA registration will override State Boards of Pharmacy requirements.  JCB is actively pursuing all appropriate registration in each state to ensure that we stay in compliance and are able to continue shipping product to health care providers. This process will take some time but we have made significant progress. We started with states that require prescriptions for products being administered to patients within a healthcare facility in an effort to help them become more efficient as soon as possible.  JCB is contacting current clients in those states where the appropriate registration has been obtained and approved.  Clients have been very excited and relieved.  We will continue to keep you updated on any changes that occur related to individual state boards or with the FDA.    

Tag: 503B, outsourcing facility, FDA, DQSA, State Boards of Pharmacy,

Post NECC - What's Next for Sterile Compounding

Posted By Brian Williamson on Wed, Apr 24, 2013 @ 15:04 PM

The sterile compounding industry has been under a microscope for the last six months.  Since the New England Compounding Center tragedy, a few other compounding pharmacies have issued voluntary and mandatory product recalls.  The recalls have been primarily related to “lack of assurance of sterility” and have been brought about by either patient infections, floating material in products, or both.  Additionally, the FDA has completed the inspection of 30 compounding pharmacies and the information gathered is being summarized and processed to determine how to regulate compounders going forward.  

It is important to note that all the FDA inspections were done using current Good Manufacturing Practices (cGMP) standards instead of USP 797.  Sterile compounding pharmacies are regulated by state boards of pharmacy and most boards require sterile compounding pharmacies to be compliant with USP 797.  So, it is not surprising that all of the pharmacies received inspectional observations form FDA 483 when inspected against cGMP standards.  USP 797 has been the “gold standard” for sterile compounding pharmacies for years.  Products prepared and the testing of those products using USP 797 procedures results in sterile products that are safe.  It is when sterile compounding pharmacies cut corners or do not follow USP 797 to the letter that problems can occur.

The cGMP standards are more stringent than USP 797 in some areas, most notably in air sampling requirements and validation of compounding and testing methods. Going forward, we expect there to be requirements put in place that incorporate parts of USP 797 and cGMP. The greatest predictor of things to come can be summarized by a statement made on March 23, 2013 by FDA Commissioner, Margaret A. Hamburg, M.D.  Her statements indicate that the FDA, in cooperation with state boards of pharmacy, will continue inspections of compounding pharmacies.  Commissioner Hamburg asked Congress to draft legislation establishing minimum federal standards for firms that compound sterile drug products, and wants Congress to enhance the FDA’s authority to inspect pharmacies, asking for the “FDA [to] have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.”  Two areas that the FDA seems to be set on changing or adding oversight is compounding of sterile products in anticipation of an order or prescription and large-scale interstate shipping of products.  We have already seen many states either starting to enforce their regulations regarding “office-use vs. prescription” compounding, or implement emergency regulations to prohibit office-use compounding, or both.  

So, what does this mean for you, for JCB, and for the patients you serve?  As many of you know, the changes made by many states requiring prescriptions for compounds is a logistical nightmare.  It is time consuming, costly, and likely not the best approach to ultimately protecting patient safety.  There are better ways to track lot numbers of products to individual patients and many of you are already doing this.  Nevertheless, JCB Labs will comply with the rules and regs put in place by each state board of pharmacy and will help you remain compliant as well.  If you are in a state that requires prescriptions for office use compounds, we will continue to ask you for prescriptions unless or until the regulations are changed.  

It appears that the FDA will likely have more oversight in the compounding industry.  Whether or not this happens, JCB will continue to provide sterile products of the highest quality and help ensure the safety of your patients. JCB’s facility is always open for you to visit or audit.  If you do come to visit JCB, we are confident that you will leave completely satisfied that you are working with a sterile compounding partner you can trust.  

Tag: USP 797, compounding, FDA, sterile, Injectable,

Speak Up - Your Patient's Health & Wellbeing May Depend on It

Posted By Brian Williamson on Tue, Mar 12, 2013 @ 08:03 AM

 


Increased scrutiny and regulatory oversight, brought about by the failure of NECC and the resulting tragedy, now threaten to limit your access to sterile compounded products. Many of you contract with a sterile compounding pharmacy, such as JCB Labs, to provide sterile products when a manufactured product is not a viable option.

This vital resource may be severely restricted by looming legislation and/or by reinterpretation of pharmacy laws. Specifically, there are three areas of concern:

1) FDA regulations and oversight - While JCB agrees that further oversight is necessary and could support FDA oversight on some level, the regulations need to be enacted judiciously and with ease of access and patient care in mind.

2) Patient specific prescription requirements - Some states do not allow office-use compounding and require patient specific prescriptions.  This requirement may be difficult or even impossible to work into the logistics of your practice, but it is very important that you follow the board of pharmacy regulations in your state.

3) Out of state pharmacy restrictions - Some boards of pharmacy are considering statutes that would preclude out-of-state pharmacies or non-resident pharmacies from shipping product into their state.  Or, they may put some arbitrary limit on the amount of office-use product a pharmacy can provide.

The end result of such restrictions could severely limit your access to the office-use compounded drugs you depend on. The rhetoric behind these restrictions and requirements indicate they are meant to improve patient safety.  Is that what they would accomplish?  Wouldn’t it be better to focus on creating and enforcing standards that result in products of the highest quality without limiting access?

If your practice relies on compounded products for office-use, it is imperative that you contact your legislators and board of pharmacy in your state.  Express to them the absolute need for office-use sterile compounded products in your practice.  Make sure that your representatives understand that the ONLY source you have for many drugs used in your practice is your compounding pharmacy.  We’ve included a example text for your use at the end of this blog.  Personalize it any way you see fit and email or send it to your board of pharmacy and your state legislators.

On a brighter note, one board of pharmacy has taken an introspective and reasonable approach to office-use compounding.  The Washington State Board of Pharmacy published the following:

“The Washington State Board of Pharmacy recently discussed pharmacy compounding... [T]hey agreed that (4), read independently, could allow a pharmacy to provide compounded products for a practitioner to administer to individual patients without a prescription for a specific patient.  Because this has clearly been the belief of some compounding pharmacies in Washington, the board decided it will honor this interpretation of the rule...”

You CAN make a difference.  Your legislators will listen to you and the board of pharmacy will hear your concerns.


Example letter:

Dear [Board of Pharmacy, Legislator, Congressman, etc]

Thank you for taking time to hear my concern.  I am a [physician, administrator, nurse, etc.] at [Example Surgery Center].  I am concerned about the possible impact that potential regulations and restrictions to compounded drugs for office-use would have on my practice.  

I regularly depend on office-use compounded products to meet my patients’ needs when a suitable manufactured product is not available.  The ONLY alternative I have is from a licensed compounding pharmacy.  Any further regulations or restrictions on office-use compounding need to be carefully weighed against patient need and access to critical drugs.

Please do not restrict or limit my access to vital compounded sterile products without considering the significant impact it would have on my patients and my practice.

Sincerely,
Tag: Sterile Compounding, FDA, Legislator, Health,