What USP <797> has to say about beyond-use dating of stock bags

Nothing. It says nothing, which leaves things open to interpretation. That’s bad.

Beyond use dating (BUD) in USP <797> is pretty straightforward, but there’s really no language in there describing stock bags.

Here are some things to think about. When performing routine compounding, USP <797> states that in the absence of sterility testing, the assigned BUD must not exceed the following:

USP 797 BUD for temp and risk
Continue reading What USP <797> has to say about beyond-use dating of stock bags

Saturday morning coffee [July 24 2015]

To be idle is a short road to death and to be diligent is a way of life; foolish people are idle, wise people are diligent.” – Buddha

So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….

The mug below comes straight from the Hula Daddy Coffee Plantation in Kona, HI. My family and I recently spent a week in Kona on vacation. The island isn’t what I expected, but we had a great time. There are so many interesting things to do, and the differences in landscape and climate are crazy in such a small area.

MUG_HulaDaddy
Continue reading Saturday morning coffee [July 24 2015]

More thoughts on the ASHP national survey results for informatics and pharmacy practice

On Monday I spoke briefly about two articles in AJHP that summarize two recent ASHP surveys. The first covers Pharmaccy Informatics in U.S. Hospitals(1), while the second focuses on pharmacy practice in acute care hospitals(2).

Both surveys contain a wealth of information, and provide a snapshot of what pharmacies in the U.S. are doing. While conducted at different times by different groups, I think it’s more interesting to look at the two surveys together. As I mentioned in my podcast, the adoption of automation and technology goes hand in hand with pharmacy operations. You can no longer have one without the other.
Continue reading More thoughts on the ASHP national survey results for informatics and pharmacy practice

JerryFahrni.com Podcast #1: ASHP National Survey Results

Show notes:
Host: Jerry Fahrni

The two surveys discussed in the podcast are below:

Fox, B. I., C. A. Pedersen, and K. F. Gumpper. “ASHP National Survey on Informatics: Assessment of the Adoption and Use of Pharmacy Informatics in U.S. Hospitals–2013.” American Journal of Health-System Pharmacy 72, no. 8 (April 15, 2015): 636–55. doi:10.2146/ajhp140274.

Pedersen, C. A., P. J. Schneider, and D. J. Scheckelhoff. “ASHP National Survey of Pharmacy Practice in Hospital Settings: Dispensing and Administration–2014.” American Journal of Health-System Pharmacy 72, no. 13 (July 1, 2015): 1119–37. doi:10.2146/ajhp150032.

The FDA has delayed enforcement of “track and trace”

Hear that? That’s a collective sigh of relief from pharmacy directors everywhere.

Modern Healthcare: “The Food and Drug Administration is giving pharmacies another four months before they’re penalized if they can’t document the chain of custody for the drugs they dispense. The requirement was adopted under a 2013 law passed in response to a meningitis outbreak traced to a compounding pharmacy.” – The original deadline for enforcement was July 1. Groups such as ASHP have been lobbying to get the FDA to hold off enforcing the July 1 deadline. Looks like it worked.

Just in case you didn’t know, the Drug Quality and Security Act (DQSA) was signed into law on on November 27, 2013. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA) creates new definitions and requirements related to product tracing. The idea of the DSCSA is to build an electronic, interoperable system of tracking prescription drugs (“products”) by November 27, 2023.

The DSCSA replaces the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and preempts state requirements – killing what California was trying to do – and applies to transactions or changes in ownership of products.

Under the DSCSA manufacturers, wholesale distributors, repackagers, and dispensers are required to provide the subsequent purchaser with product tracing information when engaging in transactions involving certain prescription drugs, thus creating a barrier for counterfeit medications entering the market.

People have been scrambling for a while to be compliant, but it’s been an uphill battle for many. I’ve sat through several webinars, and it’s clear that there is still much confusion. It’s a good thing the FDA handed out a four month reprieve. However, it’s unclear whether or not an additional four months is enough.

You can read more about the DSCSA at the FDA website here. Enjoy!