Medical Professionals Advocating for Continued Access to 503A Compounding Pharmacy Drugs at the California Board of Pharmacy’s Subcommittee Regulation Hearing
On June 18th, the California Board of Pharmacy (CA BOP) held a regulation hearing on compounded drug preparations. McGuff’s management team, along with an estimated attendance of over 100 people, including medical professionals from diverse specialties, attended this three-hour subcommittee meeting. Their goal was to advocate for continued access to sterile compounded drugs from 503A compounding pharmacies.
The meeting was a public hearing by the CA BOP to receive comments on proposed regulations. Various stakeholders, including pharmacists, medical professionals, and representatives from different organizations, provided their feedback. The main focus was on the impact of these regulations on compounding practices, patient care, and the operations of healthcare facilities.
The purpose of the hearing was not to debate, but for the CA BOP to collect comments on the proposed regulations. Participants were allotted five minutes to provide their oral comments. In addition, they encourage stakeholders to submit their written comments to provide more detailed input.
The board will be voting on this issue soon and concerned providers want to make sure their patients (human and animal) have continued access to necessary treatments. Glutathione and Methylcobalamin are two of the compounded drugs at risk, and many doctors claim their patients are experiencing significant health benefits from them.
Many of the stories shared in the hearing included personal testaments from firefighters, law enforcement officers, military veterans, as well as civilian patients with debilitating health conditions. These stories underscored the impact these regulations would have on patients and providers.
Specific 503A Compounded Drugs Deemed Beneficial from Testimonies:
These specific compounded drugs were highlighted for their critical role in patient and animal care, illustrating the significant impact that regulatory changes could have on access to essential medications.
Glutathione:
• Mentioned by several speakers, including Stephanie Ensley and multiple firefighters, as crucial for detoxifying the body from harmful chemicals and heavy metals.
• Glutathione infusions were highlighted as lifesaving for individuals with mold toxicity, heavy metal poisoning, and chronic infections.
• Firefighters discussed its role in reducing toxin levels and potentially preventing cancer.
Buffered Lidocaine:
• Widely used in dermatology and plastic surgery for reducing pain during procedures.
• Dermatologists emphasized its necessity for patient comfort and effective care.
• Orthopedic surgeons also use a mixture of lidocaine and corticosteroids for joint injections, citing less pain for patients and improved diagnostic precision.
Antifungal Ophthalmic Medications:
• Used to treat fungal keratitis in animals, especially horses.
• Veterinarians face challenges procuring these medications, which include miconazole, itraconazole, natamycin, and voriconazole.
• Delays in treatment due to unavailability can lead to severe outcomes, such as blindness.
Thyrotropin Releasing Hormone:
• Important for diagnosing equine diseases.
• Veterinarians expressed difficulty in obtaining this compounded medication, which is not available in FDA-approved forms.
Atropine Ophthalmic Drops:
• Used in various medical settings, including for treating eye conditions.
• Pharmacists highlighted the need for compounding to ensure availability and appropriate shelf-life.
Some concerns expressed by the participants about compounded drugs regulations:
• Restricting physicians from properly treating their patients
• Impact of regulations on large healthcare systems and patient safety
• Immediate use compounding
• Possibly redundant and overly restrictive
• Imposes undue burdens on providers
• Financial and operational challenges
Synopsis of the Regulation Hearing:
There was a general consensus on the need to ensure patient safety and comply with federal standards. Many stakeholders requested reconsideration of certain regulatory aspects that could impose financial and operational burdens without clear evidence of improving patient safety. Suggestions included adopting USP standards without additional state-specific requirements and forming expert advisory committees to evaluate the impact of proposed regulations.
The Board is considering all comments received during the written 45-day comment period and from this regulation hearing at its anticipated board meeting on July 31 and August 1, 2024. Keep informed of the outcome on the CA SOP pending regulations site. Watch the CA BOP Regulation Hearing recording.
At this time, this proposed regulation will not affect McGuff’s ability to compound Methylcobalamin and Glutathione for California physicians and patients as a 503B outsourcing facility. However, we can only produce these compounded drugs after we receive our license approval from the CA BOP. This is one of the many benefits of transitioning our 503A to a 503B Outsourcing Facility - ensuring continued access to these essential medications.
Learn more about the latest update on the launch of our 503B outsourcing facility, McGuff Outsourcing Solutions (MOS): www.mcguff.com/503Bupdate.
We were inspired to hear the positive attributes these drugs have, and we’re hopeful the committee will respond in a meaningful way. At McGuff, we are fully vested in advocating for our physicians and their patients by providing them with safe, sterile, trusted compounded drugs.
