APC Resource Libraries
Resources for Compounding Professionals
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
APC guides to being a better advocate for compounding, from attorney Stephen Snow and his team at Bendin, Sumrall, and Ladner:
- “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: 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.
“FD&C Act Provisions that Apply to Human Drug Compounding”
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
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.