FDA extends comment period on 503B Bulks List
Last week, FDA announced that it was reopening the comment period for it’s proposed updated 503B Bulks List — the “bulk drug substances (active pharmaceutical ingredients) that FDA has considered and proposes to include or not include on the list of bulk drug substances for which there is a clinical need.”
Comments can now be submitted until February 8, 2021, and APC is considering commenting.
Simply put: We welcome member input about what should be the substance of those comments. Nothing formal (on your end); all you need to do is send an email to firstname.lastname@example.org.
The value of community
ICYMI, be sure to read this wonderful story about compounding pharmacist Eddie Levin who lost his job — and whose neighbors came to the rescue. Nothing we write could better demonstrate the value of serving your community.
Dates set for 2021 EduCon, Owner Summit
Mark your calendars!
EduCon Virtual 2021: Best Practices in Compounding will be held, well, virtually on February 4 – 5, 2021. More info to follow, of course.
And pharmacy owners and managers will want to plan on APC’s inaugural 2021 Compounding Pharmacy Owner Summit — March 26-27, 2021 at the Westin Jekyll Island on Jekyll Island, Georgia
Registration for both events will open soon.
Board approves cBHT policy
The APC Board of Directors has approved the alliance’s official policy statement on compounded bio-identical hormone therapy.
Highlights of the statement:
- APC opposes any additional regulation of cBHT.
- APC supports all compounded hormone therapy, with no preference for particular dosage forms.
- APC opposes restrictions that would limit hormone compounding to pharmacies that adhere to cGMP.
Click here to read the full statement, and visit A4PC.org/cbht for all our latest information on the fight to protect cBHT.
On-demand CE, so you don’t miss a thing
Did you miss our webinar on the truth about peptides compounding? Or maybe e-prescribing? No worries: APC’s got you covered with our on-demand CE archive of those courses and more, just for compounders.
If you’re looking for a particular class — or just to top off your CE requirements — don’t settle for same-old, same-old content. Visit A4PC.org/cearchive and check out our lineup of great self-paced classes covering hot topics like peptides, shortage compounding, cBHT, smart accreditation, and much more.
That’s A4PC.org/cearchive — check out what you can learn today!
Covid-19 vaccine billing guidance is available
With the first Covid-19 vaccine just around the corner, now’s the time to get your ducks in a row if you’re planning to provide vaccinations.
NCPDP has released its guidance for providing the vaccine (22-page PDF: https://fllw.me/2JTmiUO), but you probably want to start with NCPA’s overview for how you’re likely to need to bill for the vaccine: https://fllw.me/37IsJ5h.
Do you know the right way to handle e-prescribing — in compounding?
Paper prescriptions are well on their way out, so your e-script knowledge needs to be 100 percent up to date.
NCPDP Script 2017071 is the 800-pound gorilla of electronic prescribing, and you’ll want to know it backwards and forwards. APC’s new live webinar, E-Prescribing in Compounding, will help you do just that.
Taught by pharmacy compounding technology expert (and CEO of ElectricLab Software) Michelle Wong, PharmD, E-Prescribing in Compounding will teach you why 2017071 applies to you, how to use it best, and how it can help you collaborate with prescribers to enhance continuity of care.
E-Prescribing in Compounding is Tuesday, December 15, from 2:00–3:00pm EST. A mere $55 for APC pharmacist members; $30 for students or techs. Non-members pay $75. Gives 1 hour of ACPE-accredited CE.
Go to A4PC.org/escripts to register today!
Compounding supporters win races
Congrats to APC member Diana Harshbarger (TN-1), who will become the first compounder in Congress with her victory Tuesday. (Buddy Carter, GA-1, currently the only pharmacist in Congress, was reelected as well.)
And congrats to Alabama pharmacy owner Jerry Carl on winning Alabama’s 1st district seat! We were happy to be among his supporters and we look forward to working with him in Congress.
These are the kinds of compounding-friendly faces that APC — and, more importantly, CompPAC, supports.
APC at work: California
California’s Board of Pharmacy is considering a rather overzealous attempt to limit animal compounding from bulks, and APC is happy to support our friends at the California Pharmacists Association with a letter to the BoP opposing those changes.
Fairness and the FDA
Check out the latest entry in FDA Law Blog: “Lemonade from Lemons: Fairness in FDA Enforcement Actions.” It’s about executive order 13924, which says federal agencies “shall consider” fairness in enforcement actions. How might that apply to FDA?
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