In recent weeks there’s been a persistent rumor that the governing body for horse-racing has banned compounded drugs because they are not FDA approved. But that’s not the case. read more →
Later this spring, we’ll be debuting a new 15-hour certificate program, “The Ethical, Legal, and Regulatory Framework of Pharmacy Compounding.” read more →
The California Board of Pharmacy’s Enforcement and Compounding Committee met yesterday to discuss proposed regulations related to sterile compounding. read more →
In advance of the April 1, 2023, enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance. read more →
In response to a request from APC and NCPA, FDA’s Center for Veterinary Medicine last week issued a Letter to Industry explaining the phased-in approach to enforcement the agency plans to take on GFI 256. read more →
The Prescriber Briefs developed by APC and the Pharmacy Compounding Foundation are excellent resources for educating prescribers about pharmacy compounding—including laws, guidance, and standards you must adhere to. read more →
Since the program’s inception, 112 pharmacists have been nominated to this elite group. Thirteen new members were inducted during last year's Compounders on Capitol Hill. read more →
In advance of the Apr 1, 2023, enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance. read more →
In recent weeks there’s been a persistent rumor that the governing body for horse-racing has banned compounded drugs because they are not FDA approved. But that’s not the case.
While the syntax is a bit convoluted, the Horseracing Integrity and Safety Authority’s new Rule 4111 states that compounded drugs are clearly permissible:
Rule 4111. S0 Non-Approved Substances
Any pharmacological substance that (i) is not addressed by Rules 4112 through 4117, (ii) has no current approval by any governmental regulatory health authority for veterinary or human use, and (iii) is not universally recognized by veterinary regulatory authorities as a valid veterinary use, is prohibited at all times. For the avoidance of doubt, compounded products compliant with the Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256 (also known as Compounding Animal Drugs from Bulk Drug Substances) are not prohibited under this section S0.
We repeat: HISA’s rules allow compounded medications for equine patients from pharmacies that are compliant with the Animal Medicinal Drug Use Clarification Act and the FDA Guidance for Industry (GFI) #256.
Consider this a teaser. Sometime in late spring, we’ll be debuting a new 15-hour certificate program, “The Ethical, Legal, and Regulatory Framework of Pharmacy Compounding.” The program is being developed as a collaboration between APC, the Pharmacy Compounding Foundation, and the Virginia Commonwealth University School of Pharmacy.
“We’re creating this learning program based on the premise that understanding the regulatory framework for compounding is just as important as knowing how to compound,” said APC’s Scott Brunner. “And with a price point under $500, we aim for it to become the foundational learning program for new pharmacy compounding team members.”
Topics covered will include laws and regulations, safety, quality, training, and credibility.
The California Board of Pharmacy’s Enforcement and Compounding Committee met yesterday to discuss proposed regulations related to sterile compounding.
During the four-hour-long meeting, APC legislative and regulatory counsel David Pore shared concerns about how proposed changes to regulations will impact patients in the state. Notably, the proposals are inconsistent with USP 797, aim to make USP Chapters 1000 and above enforceable in California – something USP itself clearly does not recommend – and state that items on FDA’s interim list for bulk substances may not be compounded.
APC is submitting a formal comment letter addressing our serious concern that the proposals are well out of sync with nationally recognized standards, will sow confusion among licensees and dampen their ability to serve patients.
“Patient access is the real issue here,” says APC’s Scott Brunner. “These policies aren’t rooted in any particular science and well exceed national standards like USP and FDA guidance. The California BOP has not demonstrated how patients are made safer by these proposals. Instead, this is a state agency charged with protecting the public that is pursuing restrictions that will ultimately disadvantage California patients who rely on compounded medications to live normal lives.”
Check out the latest public policy update video from APC Director of Public Policy Savannah Cunningham, PharmD. It highlights five things you need to know right now about APC, our industry, and our advocates. It’s short, not even 4 minutes long—perfect for showing at your next pharmacy team meeting.
Hosted by APC Director of Public Policy Savannah Cunningham, each month we share a short video focused on five things you need to know right now and how you can help us in protecting and promoting your compounding practice.
In advance of the April 1, 2023, enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance–and to make sure the veterinarians you work with understand the changes required by GFI 256.
All compounding pharmacists, technicians and other compounding team members are invited to join PCCA Vice President of Clinical Services A.J. Day, PharmD, and PCCA Director of Clinical Services Matt Martin, PharmD, BCSCP, to learn what’s new in GFI 256 and what you need to know now.
Learning objectives:
Describe the legal framework that GFI 256 discusses for animal drugs.
Identify the parameters for compounding patient specific animal medications in GFI 256.
Illustrate how to differentiate a compounded animal medication from a copy of a manufactured drug product.
Analyze situations when compounding from a manufactured drug product can produce an unacceptable final compounded preparation.
Review the criteria for compounding for office stock and how drugs can become eligible for FDA’s list related to this.
Program details:
March 22 • 12pm – 1pm CT
Cost: $25 per person. with the proceeds going to APC
In response to a request from APC and NCPA, FDA’s Center for Veterinary Medicine last week issued a Letter to Industry explaining the phased-in approach to enforcement the agency plans to take on GFI 256.
“We’re grateful to CVM for this important communication,” said APC Board Chair Anthony Grzib. “In tandem with the answers to our technical questions CVM shared with us last month, it helps pharmacy compounders and state boards of pharmacy understand FDA’s thinking.”
Let’s face it, prescribers don’t always understand compounding. Some seem to think you’re concocting potions in a caldron out in the woods. Others press you to prepare formulations that are well outside the regulations for your profession.
The Prescriber Briefs developed by APC and the Pharmacy Compounding Foundation are excellent resources for educating prescribers about pharmacy compounding—including laws, guidance, and standards you must adhere to.
Best of all, you can brand them with your pharmacy name and logo. Topics in the series so far:
The regulatory framework of pharmacy compounding
Compounding Peptides: It’s Complicated
Compounding and the Wet Signatures Act
NEW: GFI 256 and Documenting Medical Rationale
And remember: These are member-only tools, so you’ll need your APC login to access them.
The APC Fellows Program recognizes the distinguished contributions our compounding pharmacist and pharmacy technician members have made to the profession and to their respective communities.
All applicants must be registered pharmacists or pharmacy technicians who have practiced pharmacy for at least five years and practiced in the compounding pharmacy profession for at least three years.
The deadline for 2023 nominations has been extended to June 1, which provides plenty of time for you to learn more about eligibility requirements and submit your application. Get started on our APC Fellows web page.
In advance of the April 1, 2023, enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance–and to make sure the veterinarians you work with understand the changes required by GFI 256.
$25 per person (All registration fees donated to APC)
CE = 1 hour
All compounding pharmacists, technicians and other compounding team members are invited to join PCCA Vice President of Clinical Services A.J. Day, PharmD, and PCCA Director of Clinical Services Matt Martin, PharmD, BCSCP, to learn what’s new in GFI 256 and what you need to know now.
Learning objectives:
Describe the legal framework that GFI 256 discusses for animal drugs.
Identify the parameters for compounding patient specific animal medications in GFI 256.
Illustrate how to differentiate a compounded animal medication from a copy of a manufactured drug product.
Analyze situations when compounding from a manufactured drug product can produce an unacceptable final compounded preparation.
Review the criteria for compounding for office stock and how drugs can become eligible for FDA’s list related to this.
Purchase includes:
CE = 1 hour (Must be claimed within 14 days of the live event.)
Recording available to paid registrants for 3 months post-live event.
With enforcement of FDA’s GFI 256 set to commence April 1, APC has developed a new Prescriber Brief to help you coach the veterinarians you work with on what they must document on prescriptions for compounded animal drugs.
It joins a suite of members-only Prescriber Briefs that include topics such as the regulatory framework of pharmacy compounding, compounding peptides, and the “Wet Signature” Act.
PS: You’ll need your a4pc.org member login to access these.
With enforcement of FDA’s GFI 256 set to commence April 1, APC has developed 
