Compounding pharmacies are critical when prescribers need a unique, patient-specific prescription when there are no other options for their patient. Compounding pharmacies provide the United States with an essential safety net to address drug shortages and to treat conditions for which there is no commercially manufactured medication that will work. Compounding pharmacies face a number of operational risks.
Operating a compounding pharmacy means following an endless list of complex state and federal laws. These laws have expanded in recent years, altering how compounding pharmacies are categorized, regulated, and inspected. Increased regulation is often touted as vital for the health and safety of patients, but it sometimes there is a lack of science behind these regulations and make running a compounding pharmacy complicated and challenging.
If a pharmacy fails to meet governmental regulations, it may see administrative, civil, and even criminal penalties. Compounding pharmacies are subject to increasing governmental scrutiny, and the pharmacies may not have the systems in place to ensure regulatory compliance. A compounding pharmacy attorney is an invaluable business partner for compounding pharmacies.
The compounding pharmacy attorneys with Boesen & Snow can help you create or update the regulatory policies in your pharmacy. At Boesen & Snow, we have decades of experience in business, health care, and pharmacy law. Our team also has experience in business management, pharmacy leadership, business audits, and working in the health care sector. We understand the regulations and pressures you’re dealing with because we have direct experience with it.
At Boesen & Snow, our goal is to help the business owners of compounding pharmacies run profitable and productive companies while complying with the necessary regulations. Compounding pharmacies provide a valuable service to patients who need them, and the health and safety of these patients are important. Following regulations helps keep patients safe, and it mitigates the pharmacy’s liabilities during inspections or audits. Our attorneys can help your pharmacy create a comprehensive plan for outlining and enforcing regulatory compliance.
There are both state and federal agencies with legal authority over certain aspects of compounding pharmacy operations. The practice of compounding is overseen and regulated by the states through their Boards of Pharmacy. The components and finished compounded products may be subject to additional oversight of the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA).)
Under federal law, compounding pharmacies are categorized as 503A pharmacies or 503B Outsourcing Facilities. Although both of these types of pharmacies are governed by the same agencies, there are some differences in their regulations and requirements under the federal Food, Drug, and Cosmetic Act (FDCA).
The FDA oversees the distribution and manufacture of prescription drugs that are used in compounded medications.
The FDA also enforces the standards authored by the United States Pharmacopeia (USP), a nonprofit organization that uses a expert-committee consensus process to publish guidelines used to recommend best practices for storage, handling, and compounding medications. Guidelines and standards published by USP are intended to ensure the purity, potency, quality, and identity of medications, supplements, and other ingredients used to create compounded prescriptions. Important chapters in USP standards include:
Although the USP has no authority to regulate these standards, they are sometimes used by the FDA, state boards of pharmacy, and state public health departments when permitted by the appropriate administrative procedures governing federal, state, and local governments.
USP General Chapter ‹797› sets guidelines intended to ensure that compounded sterile drugs are prepared safely. USP ‹797› standards may apply to a pharmacy that creates compound sterile medications, including those located in:
The standards may apply, depending on your jurisdiction, to the person compounding sterile preparations, including nurses, pharmacy technicians, pharmacists, physicians, and any other allied health professional. Chapter ‹797› was drafted as a tool for state and federal agencies to use in the protection of public health and safety. These guidelines exist in an effort to prevent risks and deaths of patients by avoiding the following health concerns in compound sterile preparations:
Compliance with USP ‹797› for compounding pharmacies can be challenging, but specific policies and the implementation of these policies can ensure compliance. Any pharmacy that is subject to complex and multi-layered regulation, and the laws governing compounding pharmacies can be even more complicated. Working with a compounding pharmacy attorney can help you create a policy that meets the needs of your compounding pharmacy while helping you adhere to state and federal regulations. Creating a system to ensure compliance includes:
The old guidelines for USP ‹797› divided risk levels according to the risk level of the pharmaceutical compounds themselves. After revision, USP ‹797› determines the risk level of sterile compounded preparations based on of the facility in which they are made and the length of time within which the compounded preparations must be used. Category 1 sterile compounds have shorter Beyond Use Dates (BUDs) and may be prepared in an unclassified segregated compounding area. Category 2 sterile compounds have longer BUDs and must be prepared in a cleanroom suite. Category 3 sterile compounds are those that may be assigned longer BUDs than the limits for Category 1 or Category 2 CSPs, up to 180 days, if additional requirements are met.
For a compounding pharmacy to determine its compliance obligations, it has to first know what facilities are required for the services that it provides or will provide. An attorney can help your compounding pharmacy understand the requirements for the compounded medications you make or the type of location that you already have or may need. Our attorneys can then help you create and implement a policy to comply as well as train your staff on those policies.
To comply with any regulation, a business and/or pharmacy needs policies and procedures that outline the steps that employees, staff, and third parties must take. This is also true when complying with USP ‹797›. Policies should cover areas such as:
A compliance attorney knows how to plan and implement USP compliance in your compounding pharmacy. They can review your current policies and daily business operations to create programs that cover your unique needs.
Pharmacy staff who perform sterile compounding have to be regularly and comprehensively trained to follow USP ‹797› regulations. This training should be individualized to the various roles of the employees, including pharmacists, pharmacy technicians, and other staff. This training may cover essential aspects of USP ‹797› compliance, such as:
A regulatory attorney can help create a system to educate new employees on proper regulation and a schedule for consistent training. Training may need to be reiterated semi-annually or annually, depending on the facility and the needs of the regulations. An attorney can also help you remain on top of changes to these laws and regulations.
USP General Chapter ‹795› provides similar guidelines for compounded nonsterile preparations. Nonsterile compounds are prescription medications that are administered orally or topically. USP ‹795› guidelines address issues such as:
Just as with USP ‹797›, ensuring regulatory compliance requires the creation and implementation of policies, including regular staff training. During any inspections, policies and procedures aren’t enough. These procedures must be effective and clearly integrated into all relevant aspects of your business.
The goal of USP General Chapter ‹800› is to protect patients, staff, and the environment from hazardous drug exposure in healthcare settings. Compliance with USP ‹800› includes:
An attorney can review what policies and procedures your compounding pharmacy needs to meet these USP requirements, if applicable, and how to effectively implement them in a way that helps your business succeed.
Compliance with state and federal regulations is essential to patient protection and the growth and sustainability of your business. Compounding pharmacies and other pharmacy facilities are part of a highly regulated sector of business. It can be difficult to properly comply with all these laws and regulations, but failure to do so can lead to significant civil, administrative, and even criminal penalties. It could lead to the revocation of a pharmacist’s or physician’s license or the revocation of the pharmacy’s registration.
An experienced attorney can help with regulatory compliance. They can help you determine what laws your compounding pharmacy is subject to and what you may be exempt from. If you are opening a compounding pharmacy, one of our attorneys can review your business goals and create a plan for compliance. Creating policies at the beginning of your company severely limits your risk of liability and penalties.
If you own an existing compounding pharmacy, a regulatory attorney can review the policies you have in place, find weaknesses and risks, and determine what changes need to be made. When you work with an experienced attorney, you can begin preventing company liability. At Boesen & Snow, we can help with several regulatory issues for pharmaceutical businesses, including:
When you work with the experienced attorneys at Boesen & Snow, we can provide you with comprehensive care and protection that meets the unique needs of your compounding pharmacy.
Pharmacies have a legal requirement to monitor for prescription fraud and prevent controlled substance diversion (corresponding responsibility). This includes ensuring that pharmacies comply with DEA rules when dispensing electronic, verbal, faxed, or hard copy prescriptions. If a DEA or Board of Pharmacy audit determines that a pharmacy does not have or is not following an acceptable policy to prevent prescription fraud, the pharmacy can face fines and other adverse actions. Staff, including your managers, pharmacists, or pharmacy technicians could even face criminal prosecution. Federal and state law enforcement expect pharmacists to refuse to dispense a medication and take mitigation measures when red flags cause the pharmacist to suspect a prescription for a controlled substance may be fraudulent, dangerous to the patient, or not meet medically necessary reasons for the order.
There are other instances in which a pharmacist may refuse to fill a prescription that are separate and distinct from controlled substance corresponding responsibility rules. Pharmacists have a responsibility to address and mitigate prescription orders that interact with another prescription drug that the patient is taking, does not meet safe dosing for the pharmacodynamics related to the patient, is duplicative of another therapy the patient may be taking, or lacks sufficient information to proceed with dispensing safely. In rare circumstances, pharmacists may be uncomfortable dispensing a prescription medication due to his or her moral or religious beliefs. Under many states’ laws, a pharmacist is allowed to refuse to fill a prescription on the basis of their religious beliefs as long as they don’t act with unprofessional conduct. In these situations, a pharmacy may not allowed to fire a pharmacist for refusing to fill a prescription, as long as the pharmacist’s religious belief is sincerely held by the pharmacist and their conduct was consistent with corporate policies (that may require the pharmacist inform the employer of their beliefs), and professional standards of conduct.
No pharmacy or health care entity should overlook the necessity of regulatory compliance. For compounding pharmacies, these regulations are vital for patient safety and security. At Boesen & Snow, we know the day-to-day issues that you face while operating a pharmacy, and we want to make compliance easier for you. We understand how health care and pharmacy laws interact and affect compounding pharmacies. Our firm can aid you in implementing, monitoring, and improving programs and policies for compliance in your pharmacy. The attorneys at Boesen & Snow want to help protect your company from liability and remain effective and profitable. Contact our team today to see how our pharmacy and business professionals can help protect you and your business.
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