This is our final section in our series how USP chapters are referred to as guidelines, but that hardly means they are optional. If pharmacy caregivers provide compounded medications (sterile, non-sterile and/or hazardous), they can be audited by state boards of pharmacy, accrediting bodies, and even the FDA. These surveyors are also becoming more expert in the chapters and their content, and spending more time reviewing policies and procedures, but also interviewing team members involved in the work. The newly minted “Designated Person” is not just a gender-neutral description, but a critical role in ensuring quality measures are clearly met.
While I have worked in hospital areas most of my career, compounding pharmacies play a crucial role in the healthcare system by providing customized medications tailored to individual patient needs. These pharmacies must adhere to specific regulations and guidelines to ensure the safety and efficacy of their products. Among these guidelines, the United States Pharmacopeia (USP) <795>, <797>, and <800> set the standards for non-sterile, sterile, and hazardous drug compounding, respectively. However, the enforcement and interpretation of these guidelines can vary significantly from state to state, influenced by local laws and regulations. Those not licensed to require historic FDA inspections can still find themselves seeing FDA surveyors walk in the door and have reason to stay until they are satisfied with the results. This can be confirmed in the 483’s publicly available where the FDA acknowledges they may not be a 503b facility, but the compounding practices can be subject to FDA scrutiny
I spent the last few weeks learning where most of the FDA inspections resulted in 483’s (document outlining the observed violations) were easily more common in Florida, Texas and California. After digging deeper, this is due to the increased volume of compounding pharmacies in these states. The large volume of these licensed are not just a result of larger populations, but also state laws that can be favorable to support these practices. California may be the exception, as they cleanly have unique scrutiny built into their law as its BOP has taken extra steps to regulate compounding expectations and the resulting surveys. Having practiced in Utah and Idaho in my career, with oversight in other states, I have appreciated state law that points towards implementing these chapter elements without extra stipulations. This also helps underscore the importance of USP and the work they perform.
This blog post explores how state licensing for compounding pharmacies in Florida, Texas, and California contrasts in relation to USP guidelines, examining the impact of these differences on pharmacy operations and patient care. Oregon and Idaho examples to contrast other ways states have managed these risks.
The Role of USP Guidelines in Compounding Pharmacies
USP <795>, <797>, and <800> are essential standards that provide guidelines for the compounding of medications. These guidelines are designed to protect patient safety by ensuring that compounded medications are prepared in a controlled environment with appropriate procedures to prevent contamination and ensure accuracy.
USP <795>: Covers the compounding of non-sterile preparations, providing standards for compounding facilities, personnel qualifications, hygiene, and documentation.
USP <797>: Addresses sterile compounding, which involves more stringent requirements due to the higher risk of contamination. It includes guidelines for the compounding environment, personnel training, quality assurance, and beyond-use dating.
USP <800>: Establishes standards for the safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and the environment. This guideline applies to all healthcare personnel who handle hazardous drug preparations and includes requirements for facility design, personal protective equipment, and safe work practices.
State boards of pharmacy are responsible for adopting and enforcing these guidelines, and their approach can vary widely, resulting in significant differences in how compounding pharmacies operate across the country.
With the rise of compounding pharmacies blatantly advertising for GLP-1 “me-too” compounded medications across our country, its also important to note there may be increased scrutiny of these pharmacies even if they have very proper compounding methods hard coded in their business model. I will not address any of those here.
Florida: A Flexible Approach with Strong Oversight
Regulatory Environment: Florida is known for its supportive yet carefully regulated environment for compounding pharmacies. The state’s Board of Pharmacy has adopted USP <795> and <797> as the minimum standards for compounding but allows some flexibility in how pharmacies implement these guidelines. This flexibility is evident in the state’s allowance for office-use compounding, where pharmacies can prepare medications in advance for use by healthcare providers in their offices without a patient-specific prescription.
Office-Use Compounding: Florida’s regulations permit compounding pharmacies to prepare and distribute medications to healthcare providers for office use, a practice that is prohibited in some other states like California. This regulation enables Florida pharmacies to serve a broader range of clients, including doctors and clinics, thereby increasing their market reach and service offerings.
Inspection and Compliance: Florida’s Board of Pharmacy conducts regular inspections of compounding pharmacies, with a focus on compliance with USP standards, including <795>, <797>, and <800>. While the state provides a supportive environment for pharmacies, it also maintains rigorous oversight to ensure patient safety. Inspections typically evaluate adherence to these standards, including facility cleanliness, personnel training, and documentation practices.
Impact on Pharmacy Operations: The relatively flexible regulatory environment in Florida allows compounding pharmacies to innovate and expand their services. However, the state’s inspection process ensures that this flexibility does not come at the expense of patient safety. Pharmacies in Florida must strike a balance between leveraging regulatory flexibility and maintaining strict adherence to USP guidelines.
In my professional life I have seen compounded products shipped to patients and family members. I am unaware of concerns that came from these compounded products, but anecdotal evidence is biased.
Texas: A Supportive Yet Stringent Regulatory Framework
Regulatory Environment: Texas also offers a supportive environment for compounding pharmacies but with a more stringent regulatory framework compared to Florida. The Texas State Board of Pharmacy strictly enforces USP <795>, <797>, and <800> guidelines, with additional state-specific requirements that enhance patient safety.
Office-Use Compounding: Similar to Florida, Texas allows compounding for office use, but with stricter guidelines regarding labeling, distribution, and documentation. Texas pharmacies must ensure that all compounded medications meet the state’s safety standards, which are often more stringent than the minimum requirements set by the USP.
Oversight and Compliance: Texas has a strong oversight mechanism, with frequent inspections by the state Board of Pharmacy. These inspections focus on compliance with USP <795>, <797>, and <800>, as well as state-specific regulations that govern compounding practices. Texas requires pharmacies to have robust policies and procedures in place to ensure that all aspects of compounding meet regulatory standards.
Pharmacy Technician Support: Texas law permits certified pharmacy technicians to have a greater role in the compounding process under the supervision of a licensed pharmacist. This support structure allows pharmacies to manage their workload more effectively, ensuring that they can meet demand while maintaining compliance with USP guidelines.
Impact on Pharmacy Operations: The stringent regulatory framework in Texas ensures high standards of safety and quality in compounding pharmacies. While the state allows for office-use compounding, the additional regulatory requirements and oversight make it imperative for pharmacies to maintain meticulous records and procedures. This environment supports the growth of compounding pharmacies while ensuring that patient safety remains the top priority.
California: Stringent Regulations and Rigorous Enforcement
Regulatory Environment: California is known for having one of the most stringent regulatory environments for compounding pharmacies in the United States. The California State Board of Pharmacy has adopted USP <795>, <797>, and <800> as foundational guidelines but has implemented additional state-specific regulations that often exceed federal requirements.
I have seen a handful of 503B pharmacies come and go, and typically the instability follows when the California BOP issues concerns in the business or compounding practices.
Prohibition on Office-Use Compounding: Unlike Florida and Texas, California does not allow traditional compounding pharmacies to prepare medications for office use. All compounded medications must be patient-specific, which limits the flexibility of compounding pharmacies in the state. This prohibition reflects California’s emphasis on patient safety and its concern about the potential risks associated with non-patient-specific compounding.
Inspection and Compliance: California conducts frequent and rigorous inspections of compounding pharmacies, focusing on adherence to both USP guidelines and state-specific regulations. The state is known for its strict enforcement of compounding laws, with significant penalties for non-compliance. Inspections in California are comprehensive, often including detailed assessments of facility conditions, personnel training, and compounding processes.
USP <800> Compliance: California’s adherence to USP <800> is particularly stringent, with rigorous requirements for handling hazardous drugs. This includes strict protocols for the use of personal protective equipment, facility design, and environmental controls. California pharmacies must demonstrate full compliance with these standards during inspections.
Continuing Education Requirements: California mandates additional continuing education for pharmacists involved in compounding. This includes a mandatory one-hour compounding credit as part of the overall continuing education requirements for pharmacists. This requirement ensures that pharmacists stay updated on the latest compounding practices and regulatory changes, further enhancing patient safety.
Impact on Pharmacy Operations: The stringent regulatory environment in California creates a challenging landscape for compounding pharmacies. The prohibition on office-use compounding limits the range of services that pharmacies can offer, potentially reducing their market reach. Additionally, the rigorous inspection and enforcement regime requires pharmacies to maintain exceptionally high standards of practice. While these regulations may pose operational challenges, they also ensure that compounded medications in California meet the highest safety standards.
Implications for Pharmacy Owners and Practitioners
For pharmacy owners and practitioners, understanding the regulatory environment in their state is crucial for ensuring compliance and successful operations. Those operating in Florida and Texas may benefit from the flexibility offered by these states, particularly in terms of office-use compounding. However, they must also be prepared to meet the stringent oversight and documentation requirements imposed by their state boards of pharmacy.
In California, pharmacy owners must navigate a more challenging regulatory landscape. The prohibition on office-use compounding and the stringent enforcement of USP guidelines require pharmacies to focus heavily on patient-specific compounding and meticulous adherence to state regulations. This environment, while demanding, ensures that compounded medications in California are produced under some of the highest standards of safety in the country.
Other State Examples
I want to be clear there are other state board of pharmacy that may require a lot of their pharmacy leaders in attesting to their responsibilities to adhere to the law. Oregon infamously has a self-inspection requirement that is completed each year. In talking with leaders in Oregon, this requires a lot of preparation and review, and can cause some heartburn as you complete it and sign off.
The requirement for the Annual Self-Inspection is found in the Oregon Administrative Rules (OAR), specifically under the rules governing the Oregon Board of Pharmacy. The relevant rule is OAR 855-019-0200, which outlines the requirements for self-inspection.
Idaho is an example of a less restrictive approach that point to the requirements as they are updated in the chapters. In alignment with USP 795 for non-sterile preparations, USP 797 for sterile preparations, and other relevant chapters of the USP-NF, pharmacies must establish comprehensive policies and procedures. These policies must address critical aspects of compounding, including appropriate packaging, handling, and storage; accuracy in calculations and measurements; verification of ingredient identity and quality; accurate labeling; and establishing beyond-use dating. Additionally, pharmacies are required to implement auditing processes for deficiencies, maintain environmental quality control, and adhere to safe limits for strength, pH, bacterial endotoxins, and particulate matter. These measures are essential for maintaining high standards in pharmaceutical compounding practices
Conclusion
The comparison of compounding pharmacy regulations in Florida, Texas, and California illustrates how state-specific laws can influence the application of USP guidelines and impact pharmacy operations. While all three states prioritize patient safety, they do so through different regulatory approaches, each with its own set of advantages and challenges.
Your state may involve a different approach to how they govern and oversee the provision of safe pharmacy care in your state, but regardless of where you practice I am not seeing a decrease in scrutiny in these standards we call guidelines.
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References:
- Florida Board of Pharmacy. (n.d.). Regulations on compounding in Florida. Retrieved from https://floridaboardofpharmacy.gov
- Texas State Board of Pharmacy. (n.d.). Compounding regulations. Retrieved from https://www.pharmacy.texas.gov
- California State Board of Pharmacy. (n.d.). Compounding pharmacies in California: Regulations and requirements. Retrieved from https://www.pharmacy.ca.gov
- United States Pharmacopeia. (n.d.). USP <795>, <797>, and <800> guidelines. Retrieved from https://www.usp.org
- Frier Levitt – Attorneys at Law. (2024). Increased state-level legal and regulatory activity for 503A compounding. Retrieved from https://www.frierlevitt.com/articles/increased-state-level-legal-and-regulatory-activity-for-503a-compounding/
- IBISWorld. (2024). Compounding pharmacies in the US – Market size, industry analysis, trends and forecasts (2024-2029). Retrieved from https://www.ibisworld.com
- Oregon Board of Pharmacy. (n.d.). Self-inspection form and instructions. Retrieved from https://www.oregon.gov/pharmacy/Pages/Self-Inspection.aspx
- Idaho Board of Pharmacy. (n.d.). Sterile compounding regulations. Retrieved from https://bop.idaho.gov