Compounding Pharmacy Lawyer

Compounding Pharmacy USP Compliance Attorneys

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.

What Happens if a Pharmacy Fails to Meet Regulations?

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.

Who Has Legal Authority Over Compounding Pharmacies?

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).

• Traditional pharmacies are regulated under Section 503A of the FDCA. These businesses have certain exemptions from other regulations covered by the FDCA as long as they comply with the guidelines described in 503A. This may also exempt these facilities from some FDA authority, though the FDA is still likely to conduct inspections when they have cause.
• Outsourcing Facilities are regulated under rules implemented as a result of Section 503B of the FDCA. These facilities do not receive the exact same exemptions and are subject to more FDA authority and inspections than 503A facilities. These facilities are required to comply with current Good Manufacturing Practice (cGMP).

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:

• USP Chapter ‹›797›: Describes guidelines for the preparation, processing, and verification of compounded sterile preparations.
• USP Chapter ‹795›: Describes guidelines for the preparation of a compounded nonsterile medication.
• USP Chapter ‹800›: Sets standards that protect employees, patients, and the environment by creating quality standards and practices to limit exposure to hazardous drugs.

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.

Understanding USP Chapter ‹797›

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:

• Hospitals
• Community and retail settings
• Ambulatory and outpatient care centers
• Operating rooms
• Long-term care facilities
• Nursing stations
• Radio and nuclear pharmacies
• IV Hydration Clinics
• Veterinary hospitals and clinics
• Medical Spas

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:

• Microbial contamination or non-sterility in prescriptions
• Inclusion of inappropriate ingredients
• Errors regarding the strength of ingredients
• Excessive bacterial endotoxins

Compliance With USP ‹797›

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:

1. Determining Sterile Preparation Risk Level

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.

2. Creating Policy, Procedures, and Programs to Comply with Regulations

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:

• Controlling environmental quality
• Storage of controlled substances and sterile compounds
• Accurate BUD labeling and quality control for compounds
• Monitoring systems for patient complaints
• Internal and external reporting for adverse events and complaint reports related to sterile compounds

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.

3. Implementing Policies Through Regular Employee Training

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:

• Appropriate measures to ensure sterility of finished compounds, including disinfecting nonsterile surfaces
• Proper antiseptic hand washing
• Proper donning and doffing of appropriate protective wear
• Protection of employees and the location of contaminating substances and agents
• Identification, inventory, and measurement of ingredients stored and used in compounded preparations
• Aseptic handling of products as necessary
• Clear and accurate labeling and packaging of source ingredients and finished compounds

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.

Understanding USP Chapter ‹795›

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:

• Employee competency and training
• Hand hygiene and non-sterile compounding facility environments
• Facility cleaning
• BUD labeling
• Quality control of ingredients
• Storage and care of

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.

Understanding USP Chapter ‹800›

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:

• Training and facility controls recommended when receiving, storing, and handling
• Standards for compounding and container closure systems
• Safety, care, and effective protective personnel gear
• Proper labeling, packing, and transport of ingredients and finished compounds
• Quality control of environmental protection systems
• Decontamination procedures for hazardous materials
• Spill prevention and waste management

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.

How Can a Compounding Pharmacy Attorney Help?

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.

How Boesen & Snow Can Help

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:

• Anti-kickback laws (Anti-Kickback Statute, AKS)
• Health care fraud
• Pharmacy audits and investigations
• Corporate, local, state, and federal compliance
• DEA registration and compliance
• Stark Law Compliance
• False Claims Act Compliance and Defense
• Health Insurance Portability and Accountability Act (HIPAA)
• EPA regulation and compliance

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.

Does Arizona Law Prohibit a Company from Firing a Pharmacist for Refusing to Fill a Prescription?

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.

Boesen & Snow: Keeping Your Compounding Pharmacy Compliant

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.