Speak Up – Your Patient’s Health & Wellbeing May Depend on It


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.


Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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