Compounding Connections

Archives of our weekly member newsletter sent every Friday — 2019 through today.

Advocacy and issue information

Detailed issue information

• Saving cBHT
• FDA’s MOU on interstate shipments of compounded drugs
• Opposing FDA’s draft November 2019 GFI document on animal compounding

Issue briefing papers

• Urgent-use and shortage drug compounding legislation (HR 3662).
• Compounding with dietary supplement monographs
• Assuring robust 503A and 503B bulk lists
• APC recommendations to USP on revising USP <795> and <797> chapter beyond-use dating

Grassroots advocacy
APC guides to being a better advocate for compounding, from attorney Stephen Snow and his team at Bendin, Sumrall, and Ladner:

• Effective Advocacy With Your State Board Of Pharmacy
• Effective Advocacy With Your Legislator
• Hosting A Pharmacy Visit With Your State Or Federal Legislators

APC Guides

Tempted by peptides? Don’t do it.

• Read our short but important post on the issue of compounding peptides.

Online-pharmacy Accreditation

• “NABP .pharmacy, LegitScript, and Online Pharmacy Accreditation” by Brown and Fortunato, PC.

Stark And Anti-Kickback Updates

• “Changes to Stark and the Anti-Kickback Statute” by Brown and Fortunato, PC.

Constructive transfer

• Constructive Transfer: 2021 Update (1-page PDF)

State-level resources (MEMBERS ONLY)

Bill and reg tracking

• Compounders Stateside: State-Level Monitoring
  See the status of current proposed compounding policy in your state. Updated weekly.

State-by-state issue compilations

For APC members only, APC provides two compilations of state legislation or regulation related to compounding. Both were created in collaboration with the National Alliance of State Pharmacy Associations and funded by a generous grant from the Pharmacy Compounding Foundation.

Because these are members-only resources, you’ll need your APC log-in and password to access them.

• Compilation of State-Adopted USP 795, 797, and 800 Rules
• Compounding for Office Use and Veterinary Office Use State-by-State Resource

Free resources

“FD&C Act Provisions that Apply to Human Drug Compounding”

• From the FDA itself.

Sales-tax permits and nonprescription drugs

Do you still have to file sales-tax permits in each state for nonprescription drugs or supplements?

• The folks at TaxJar have looked into this question and compiled a state-by-state list.

And here are two additional resources worth checking out:

• TaxJar’s listing of states where dietary supplements are tax exempt or taxed at a lower rate
• The Federation of Tax Administration’s chart on state sales tax rates and food and drug exemptions (PDF)

USP <800> Risk Assessment Templates from NCPA

• Info and signup at ncpa.org/compounding.
  (Or click here to go directly to the request form.)

State-by-state e-prescribing trackers

Here are two organizations’ tracking resources on state laws and regulation on e-prescribing. Both give the same info, just the interfaces are different.

• From Surescripts: EPCS Readiness: Which States Lead the Charge?
• From MD Toolbox: E-Prescribing Mandate State Laws