Sterile Compounding-Standards & Regulations Materials

STERILE COMPOUNDING 101: STANDARDS, GUIDELINES, AND REGULATIONS

Liz Fredrickson, PharmD, BCPS

Liz Fredrickson is an Associate Professor of Pharmacy Practice and Pharmaceutical Sciences at the Northeast Ohio Medical University (NEOMED) College of Pharmacy.

Topic Overview:

Compounded sterile preparations (CSPs) are critical for patient care, and compounding personnel must adhere to various regulations, standards, and guidelines to ensure the quality, safety, and efficacy of these preparations. The risks associated with sterile compounding, including contamination, incorrect potency, and compromised sterility, can lead to serious patient harm. To ensure quality, facilities and equipment must be clean and monitored, and staff must maintain competency in personal hygiene and compounding techniques. This continuing education activity delves into the essential elements of sterile compounding practices, focusing on the regulatory frameworks, standards, and guidelines that govern these processes.

Accreditation Statement

RxCe.com LLC is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Universal Activity Number (UAN): The ACPE Universal Activity Number assigned to this activity is 

Pharmacist  0669-0000-24-177-H07-P

Pharmacy Technician  0669-0000-24-178-H07-T

Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit

Type of Activity: Knowledge

Media: Internet/Home study Fee Information: $6.99

Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Course Test and course evaluation

Release Date: December 16, 2024 Expiration Date: December 16, 2027

Target Audience: This educational activity is for pharmacists and pharmacy technicians.

How to Earn Credit: From December 16, 2024, through December 16, 2027, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Study the section entitled “Educational Activity;” and

Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

Credit for this course will be uploaded to CPE Monitor®.

Learning Objectives:

Define terms associated with sterile compounding standards, regulations, and guidelines

Describe standards and guidelines pertaining to the preparation of sterile compounds

Compare and Contrast federal and state regulation of sterile compounding

Discuss the importance of continuous professional development and education in maintaining sterile compounding competency

Disclosures

The following individuals were involved in developing this activity: Liz Fredrickson, PharmD, and Pamela Sardo, PharmD, BS. Pamela Sardo and Liz Fredrickson, PharmD, BCPS, have no conflicts of interest or financial relationships regarding the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.

© RxCe.com LLC 2024: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.

Educational Activity

Sterile Compounding 101: Standards, Guidelines, and Regulations Introduction

Compounded sterile preparations (CSPs) are critical for patient care, and compounding personnel must adhere to various regulations, standards, and guidelines to ensure the quality, safety, and efficacy of these preparations. The risks of sterile compounding, including contamination, incorrect potency, and compromised sterility, can lead to serious patient harm. To ensure quality, facilities and equipment must be clean and monitored, and staff must maintain competency in personal hygiene and compounding techniques. This activity delves into the essential elements of sterile compounding practices, focusing on the regulatory frameworks, standards, and guidelines that govern these processes.

Key Acronyms and Terms

Table 1 provides useful acronyms to assist learners. Table 2 provides a list of key terms.1,2 These can be referenced as needed throughout this activity.

Table 1 Key Acronyms1

Table 2 Key Terms

Pause and Ponder

Think about the last time you encountered a challenge in maintaining compliance with sterile compounding standards.

What strategies could you use to ensure consistent adherence to regulations, even in a high-pressure environment?

Pharmaceutical Compounding Defined

Compounding is broadly defined as the process of combining, mixing, or altering ingredients to create a medication that meets the individual needs of a patient based on a prescription.3,4 The FDA does not approve compounded medications, which can only be prepared under certain circumstances, as described in Table 3.3,4

Table 3

Reasons to Prepare Compounded Medications3,4

Compounding personnel should be able to differentiate between compounding and manufacturing. Whereas compounding is creating a personalized medication to meet individual patient needs, manufacturing is formally defined as the production, preparation, propagation, conversion, and processing of a drug or device by extracting substances of natural origin or independently through chemical or biological synthesis.4 This can include processes such as packaging or repackaging a substance, labeling or

relabeling a container, and the promotion and marketing of drugs and devices.4 Manufactured medications are mass-produced at specific strengths and dosage forms; however, the health needs of patients often do not fit a one-size-fits-all model, making compounding a vital practice to provide optimized medication therapies.4 Compared to manufacturing, compounding emphasizes the "compounding triad," which represents the collaborative relationship between the patient, pharmacist, and physician. Together, they work to identify and implement the most effective therapy, often involving compounded medications.4

Compounding encompasses two broad categories—nonsterile and sterile compounding. Nonsterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a nonsterile preparation. It will not be discussed within this program.5 In contrast, sterile compounding is formally defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation.2 Sterile compounding can be further subdivided into non-hazardous and hazardous sterile compounding. Hazardous sterile compounding involves preparing medications identified as hazardous or potentially hazardous concerning either carcinogenicity, teratogenicity, or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and/or new drugs that mimic existing hazardous drugs in structure or toxicity.6

The Importance of Regulation

Compounding personnel are responsible for preparing CSPs in adherence to established standards to ensure patient safety and therapeutic efficacy. The oversight of sterile compounding involves federal and state authorities, each of which enforces specific rules, regulations, and standards.1 Compounding standards include USP <797> Pharmaceutical Compounding – Sterile Preparations.5 USP <797> is a federal standard, not a guideline.1 States, regulatory agencies, accreditation organizations, and other organizations can make it a regulation.1 Other organizations, including The

American Society of Health-System Pharmacy (ASHP) and the Centers for Disease Control and Prevention (CDC), provide guidelines for sterile compounding. Compounding facilities and personnel should also work to stay current with regulations, standards, and guidelines to ensure the consistent delivery of safe and effective compounded medications.

Sterile compounding regulations can introduce complexity to the process but are essential for patient safety. When these regulations are not followed, the consequences can be devastating. Examples of sterile compounding errors include contamination of CSPs with bacteria or fungi, the preparation of incorrect drug concentrations, and incorrect labeling or documentation.7 Ultimately, these errors can lead to serious patient harm and even death. A bleak example is the 2012 meningitis outbreak linked to the New England Compounding Center (NECC), which caused fungal contamination in methylprednisolone injections.7 Multiple failures contributed to this tragedy, which ultimately harmed nearly 800 patients and resulted in over 100 deaths.7 NECC illegally distributed large quantities of the preparation across multiple states, a practice prohibited for compounding pharmacies under state and federal law.7 In some cases, these products were stored for extended periods, providing time for fungal growth and widespread contamination.7 This incident underscores the critical role of compounding personnel in safeguarding patient health by strictly adhering to quality standards. By following these protocols, compounding personnel can prevent similar tragedies.

A History of Pharmaceutical Compounding

The 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) marked a pivotal moment in pharmaceutical regulation, granting the FDA authority to oversee pharmaceutical manufacturing.7 Before this time, compounding pharmacies were not subject to strict federal or state oversight.7 With this act, pharmaceutical compounding remained under the jurisdiction of individual state boards of pharmacy.7 Two critical aspects of the FD&C Act include

1) requiring the FDA to approve marketed drugs based on safety, and

2) Mandating that drug labeling must not be false or misleading7

In 1997, the Food and Drug Administration Modernization Act (FDAMA) was enacted to address concerns about bulk compounders evading federal oversight by identifying themselves as pharmacies.7 Under the FDAMA, pharmacies were exempt from federal regulation if they refrained from advertising their products and adhered to safety requirements.7 The act aimed to do the following:

Ensure patient access to individualized drug therapies7

Avoid unnecessary FDA regulation of health professional practices7

Exempt pharmacists from new drug approval requirements for compounded preparations7

However, in 2002, the prohibition on advertising was deemed unconstitutional, as it violated the First Amendment's free speech protections.7 The 2013 Compounding Quality Act (CQA), part of the Drug Quality and Security Act, further clarified the division of state and federal oversight by defining two categories of compounding pharmacies:

503A Compounding Pharmacies: traditional pharmacies regulated by state boards of pharmacy which may compound only in response to individual prescriptions4,7

503B Outsourcing Facilities: facilities that are not tied to individual prescriptions and are subject to stricter federal regulations and reporting requirements to ensure quality and safety4,7

These legislative milestones have shaped the regulatory landscape for compounding, balancing patient safety, access to individualized therapy, and appropriate oversight of compounding practices.

Food, Drug, and Cosmetic Act, Section 503A

Section 503A pharmacies compound in response to individual prescriptions, but section 503A(a)(2) of the FD&C Act allows for anticipatory compounding in limited quantities.7 They are regulated by state boards of pharmacy.7 This provision permits licensed pharmacists and physicians to prepare a compounded drug product before receiving a valid prescription order

for a specific patient.7 The intent is to have the medication ready to dispense to the patient or prescriber—or for administration by a physician—once a patient-specific prescription is presented.7 This pathway significantly reduces the time needed to provide a compounded medication after issuing a prescription.

However, 503A facilities are subject to strict limitations. They are prohibited from compounding medications for general in-office use or creating copies of commercially available drugs.4,7 The CQA further restricts 503A pharmacies from distributing more than 5% of their total prescriptions out of state unless their home state enters into a Memorandum of Understanding (MOU) with the FDA.4,7 The drug substances used by 503A pharmacies must meet the following requirements:

Be covered by a USP–NF monograph, be a component of an FDA- approved drug or appear on the FDA’s approved list of bulk drug substances4,7

Not appear on the FDA’s list of drugs with demonstrated difficulty to compound4,7

Not be included on the FDA’s list of drugs withdrawn or removed from the market for safety or effectiveness reasons4,7

Due to these restrictions, 503A pharmacies largely avoid the more stringent regulations applied to drug manufacturers under the FD&C Act.4

Food, Drug, and Cosmetic Act, Section 503B

Section 503B applies to outsourcing facilities, a category of compounding pharmacies that voluntarily opt into stricter regulatory oversight by paying the FDA a user fee.7 Unlike 503A facilities, 503B outsourcing facilities do not need to operate as licensed pharmacies, although compounding must occur under the direct supervision of a licensed pharmacist.7 Additionally, 503B facilities are not required to produce medications based on individual prescriptions.7

Section 503B facilities have specific operational permissions:

They may sell compounded drugs to healthcare facilities that provide medical services directly to patients or networks of licensed providers7

They are authorized to distribute compounded preparations for office use and hospital use7

They may distribute and sell compounded preparations across state lines7

Despite these allowances, 503B facilities cannot:

Compound copies of commercially available drugs7

Use drugs listed by the FDA as demonstrating difficulty to compound7

Compound with substances that have been withdrawn or removed from the market due to safety or effectiveness concerns7

Additionally, drug substances used by 503B facilities must adhere to the following criteria:

Comply with USP–NF monographs, be included on an FDA-approved drug list, or appear on the FDA’s drug shortage list at the time of compounding7

Have a valid certificate of analysis7

Be manufactured by an FDA-registered establishment7

Sections 503A and 503B provide distinct regulatory pathways for compounding. Each pathway is tailored to specific compounding practices and patient care needs while ensuring safety and quality standards.

Organizational Oversight

Regulatory oversight of compounding practices involves state and federal organizations that interact when overseeing sterile compounding. Occupational Safety and Health Administration regulations oversee worker safety when sterile compounding.

Federal and State Oversight of Sterile Compounding

Regulatory oversight of compounding practices involves multiple organizations with distinct roles and responsibilities. State boards of pharmacy are primary regulators of compounding, providing day-to-day oversight of practices within their jurisdictions.4,8 These boards establish and enforce rules, investigate complaints, handle disciplinary actions, and ensure compliance with state laws and regulations specific to compounding.4 They oversee sterile and nonsterile compounding, regulate pharmacy operations, and require the registration and licensing of pharmacy technicians.4 Additionally, they manage record-keeping, labeling, and compounding procedures while ensuring that ingredients used in compounded preparations meet established quality standards.4

The FDA plays a pivotal role in ensuring the integrity of active ingredients and the safety of compounded products.4,8 The FDA works with state boards to inspect compounding facilities and has the authority to regulate outsourcing facilities that prepare medications in bulk without patient-specific prescriptions.4,8 The FDA also monitors insanitary conditions at compounding sites, as outlined in its Insanitary Conditions at Compounding Facilities Guidance for Industry.8 Furthermore, in collaboration with the Federal Trade Commission, the FDA addresses issues related to misleading marketing and ensures fairness in commercial advertising.8

The DEA provides oversight of controlled substances used in compounded preparations, ensuring these substances are handled and documented appropriately to prevent misuse or diversion.8 Meanwhile, the FTC shares responsibility with the FDA in regulating the fairness and accuracy of advertising for compounded medications.8

Federal and state oversight contributes to the regulation of sterile compounding. These differences are summarized in Table 4 below.4,8

Table 4

Comparison of Federal and State Oversight of Sterile Compounding4,8

Occupational Safety and Health Administration Regulations

Occupational Safety and Health Administration (OSHA) regulations play a vital role in ensuring the safety of workers involved in sterile compounding, particularly when handling hazardous drugs. The Hazard Communication Standard (HCS) [29 CFR 1910.1200] requires employers to establish a written hazard communication program that includes proper labeling of hazardous drugs, maintaining Safety Data Sheets (SDS), and providing training to employees on safe handling practices and emergency protocols.9 Similarly,

the Occupational Exposure to Hazardous Chemicals in Laboratories standard [29 CFR 1910.1450] encompasses the implementation of a Chemical Hygiene Plan (CHP), regular exposure monitoring, and the use of engineering controls such as Biological Safety Cabinets (BSCs) and Compounding Aseptic Containment Isolators (CACIs) to minimize risks.10

The Personal Protective Equipment (PPE) standard [29 CFR 1910.132] ensures that employees are equipped with appropriate PPE, including gloves, gowns, eye protection, and respirators, as needed, to protect against hazardous drug exposure.11 OSHA also enforces the Bloodborne Pathogens Standard [29 CFR 1910.1030], which addresses risks from exposure to biological materials during sterile compounding, requiring proper training, engineering controls, and needleless systems.12 Additionally, the Control of Hazardous Energy (Lockout/Tagout) standard [29 CFR 1910.147] applies to maintaining or cleaning compounding equipment, ensuring all equipment is de-energized and secure during servicing.13

Pause and Ponder

Have you proactively contacted your state board of pharmacy to inquire which sterile compounding deficiency is most commonly identified by the board so you can work on a solution or assess compliance in your

department?

United States Pharmacopeia

The United States Pharmacopeial Convention (USP) is an independent, scientific, nonprofit organization that establishes quality standards for pharmaceuticals and healthcare products.14 Founded in 1820 by 11 physicians, the USP was created to ensure patients receive high-quality, safe, and effective medications.14 A pharmacopeia is defined as a list of medicinal drugs with instructions for their preparation. USP's first publication provided a national, uniform set of guidelines for the most widely understood medicinal

substances of the time.14 This initiative laid the foundation for consistent standards in pharmaceutical practice, which continue to evolve today.

The USP-NF (United States Pharmacopeia and National Formulary) encompasses standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutic products.14 These standards are organized into chapters, with those numbered 1–999 considered enforceable by state boards of pharmacy.14 Chapters numbered 1000 and above are intended for informational purposes and provide guidance rather than enforceable mandates.14 Even if a state board of pharmacy has not codified USP into regulation, it can be used to inspect a pharmacy as it is a federal standard.1

Components of these chapters are categorized into minimum required standards and recommended best practices.1 Minimum standards are identified by the terms "shall" or "must," indicating actions or processes that are mandatory and must be strictly followed to ensure compliance.1 These requirements often serve as the foundation for ensuring safety, quality, and efficacy in practice. On the other hand, recommendations are noted by the term "should," which suggests actions or processes that are not mandatory but are strongly encouraged to enhance outcomes, optimize performance, or align with industry best practices.1 While adhering to recommendations can provide additional benefits and demonstrate a commitment to excellence, failing to meet these suggested practices does not typically result in non- compliance. Understanding the distinction between these terms is essential for professionals to prioritize their efforts and adhere to regulatory and aspirational standards.

USP Chapter <797>

USP Chapter <797>, Pharmaceutical Compounding—Sterile Preparations, was first published in 2007 and represents a significant milestone in sterile compounding practices.2 The chapter was developed in response to growing concerns about contamination and variability in

compounded sterile preparations. Its goal was to establish comprehensive, enforceable standards for the preparation, storage, and transportation of CSPs, focusing on maintaining sterility and minimizing risks of infection or error.7 Revisions to USP <797> have occurred over the years to reflect advancements in science and technology, as well as lessons learned from incidents such as the 2012 fungal meningitis outbreak linked to contaminated sterile products.1 These updates have emphasized stricter environmental controls, enhanced personnel training, and more detailed requirements for quality assurance.1

Scope and Applicability of USP <797>

USP <797> establishes critical standards for all healthcare personnel involved in sterile compounding.2 It applies to all persons who prepare CSPs and all places where CSPs are prepared.2 The requirements outlined in this chapter are designed to minimize harm, including death, to human and animal patients by addressing potential risks such as microbial contamination (nonsterility), excessive bacterial endotoxins, variability in ingredient strength, physical and chemical incompatibilities, chemical and physical contaminants, and the use of ingredients with inappropriate quality.2 Table 5 details types of CSPs that must be sterile to comply with the chapter's requirements, ensuring patient safety.2

Table 5

Dosage Forms included with USP <797>2

The requirements in this chapter must be met to ensure the sterility of any CSP. However, USP <797> does not replace USP <800>, which guides hazardous drug handling.1,2 For sterile hazardous drug compounding, compliance with <797> and <800> is necessary.1,2 Enforcement of <797> varies by state and regulatory body.1,2 Federal agencies, state boards of pharmacy, and accreditation organizations play key roles in oversight. While many states have long-standing regulations for nonsterile compounding, sterile compounding enforcement has been increasingly integrated into healthcare standards to ensure compliance with <797>. Important chapter sections within USP <797> are detailed in Table 6.1,2

Table 6

Important Chapter Sections1,2

Other Relevant Chapters

Personnel can refer to USP <800> Hazardous Drugs-Handling in Healthcare Settings for information pertaining to compounding hazardous, nonsterile preparations.15 This chapter describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection and applies to all healthcare personnel who handle HD preparations and all entities that store, prepare, transport, or administer HDs.15 Other USP chapters important for the preparation of CSPs are listed in Table 7.1

Table 7

Other Relevant USP Chapters1

Sterile Compounding Guidelines

Numerous guidelines are available to assist sterile compounding facilities and personnel. These are considered best practices and are summarized in Table 8.

Table 8

Sterile Compounding Guidelines

Sterile Compounding Continuing Education

Continuing education (CE) in sterile compounding is essential for compounding personnel to maintain competency, ensure compliance with evolving standards, and safeguard patient safety. Completing CE helps compounding professionals stay informed about updates to these standards, best practices, and technological advancements, all of which are crucial to preventing contamination, medication errors, and other risks that could jeopardize patient health.

Useful Tips

To ensure compliance with USP <797>, it is essential to adopt a systematic and proactive approach to implementing its standards. Begin by thoroughly reviewing the current version of USP <797>, along with its FAQs available on the USP website.1 Additionally, compounding personnel should familiarize themselves with sterile compounding-related components found in USP <800>, which focuses on hazardous drug handling, and USP <825>, which provides guidelines for radiopharmaceutical preparations.1 Understanding these interconnected chapters helps ensure a comprehensive grasp of sterile compounding requirements.

Facilities should perform a gap analysis by comparing the "must" statements in USP <797>, which outline mandatory requirements, with your current practices.1 They should also consider the "should" and "may" statements, which provide recommendations and optional guidelines that enhance compliance and patient safety.1 This analysis will help identify areas where processes align with the standards and areas requiring improvement.1

Facilities should develop and refine policies and procedures to ensure they align with USP <797> and support a culture of safety and compliance.1 Key organizational stakeholders, such as the direct supervisor, risk manager, and other relevant personnel, should be engaged to address noncompliant issues and advocate for the resources needed to achieve compliance. Finally, networking with other sterile compounding professionals to share insights, strategies, and lessons learned is extremely valuable. Building a community of practice can provide valuable support when implementing USP <797> standards and fostering a culture of continuous improvement in sterile compounding.1

Summary

Compounded sterile preparations are critical for patient care, and compounding personnel must adhere to various regulations, standards, and guidelines to ensure the quality, safety, and efficacy of these preparations. The risks of sterile compounding, including contamination, incorrect potency, and compromised sterility, can lead to serious patient harm. To ensure quality, facilities and equipment must be clean and monitored, and staff must maintain competency in personal hygiene and compounding techniques. Compounding personnel should understand the essential elements of sterile compounding practices, focusing on the regulatory frameworks, standards, and guidelines that govern these processes.

Course Test

Which USP chapter provides enforceable standards for sterile compounding?

<795>

<797>

<800>

<825>

What is the primary purpose of USP <797>?

To regulate the manufacturing of commercial pharmaceuticals

To establish standards for compounding only hazardous drugs

It primarily ensures sterility and minimizes contamination risks in sterile compounding

It primarily covers labeling requirements for sterile preparations

Which of the following dosage forms must comply with USP

<797> standards?

Oral tablets

Topical creams

Rectal suppositories

Ophthalmic solutions

Which entity is primarily responsible for regulating 503A compounding pharmacies?

FDA

DEA

State Boards of Pharmacy

OSHA

How do state and federal regulatory oversight of sterile compounding differ?

Federal regulations enforce stricter penalties for noncompliance and focus on quality but not safety

State regulations focus more on day-to-day pharmacy operations and in-state personnel

State regulations set the national standards for sterile compounding with a focus only on bulk compounding

Federal regulations apply only to hazardous drug handling and do not include issuing warnings

Which federal act established the framework for differentiating between 503A and 503B facilities?

Drug Quality and Security Act

Federal Food, Drug, and Cosmetic Act

Food and Drug Administration Modernization Act

Controlled Substances Act

Which of the following is a primary benefit of ongoing continuing education for compounding personnel?

Reducing the cost of compounded medications

Maintaining compliance with evolving standards and guidelines

Eliminating the need for environmental monitoring

Preventing the need for recertification

Why is professional development critical for sterile compounding personnel?

It ensures staff stay informed about technological advancements

It replaces the need for facility inspections

It provides financial incentives for compliance

It allows pharmacists to delegate compounding responsibilities

Which of the following is a method by which sterile compounding personnel can stay updated on best practices?

Relying solely on internal policies and procedures

Regularly reviewing USP guidelines and participating in networking opportunities

Focusing only on federal regulations

Delegating compliance tasks to external consultants

What is a "beyond-use date" (BUD) in sterile compounding?

The expiration date is printed on the manufacturer's label

The recommended date for recalibrating PECs

The interval for performing environmental monitoring

The date after which a CSP must not be used, stored, or transported

References

Kienle P. The Chapter <797> Answer Book, 2nd Edition. ASHP. 2023.

General Chapter: USP. Pharmaceutical Compounding-Sterile Preparations <797>. In: USP-NF. Rockville, MD: USP; September 2023.

Compounding and the FDA: Questions and Answers. US Food and Drug Administration. 11/15/2024. https://www.fda.gov/drugs/human-drug- compounding/compounding-and-fda-questions-and-answers. Accessed November 29, 2024.

Allen L. The Art, Science, and Technology of Pharmaceutical Compounding. 6th Edition. The American Pharmacists Association. 2020.

General Chapter: USP. Pharmaceutical Compounding-Nonsterile Preparations <795>. In: USP-NF. Rockville, MD: USP; September 2023.

General Chapter: USP. HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS. <800>. In: USP-NF. Rockville, MD: USP.

Watson CJ, Whitledge JD, Siani AM, Burns MM. Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors. J Med Toxicol. 2021;17(2):197-217. doi:10.1007/s13181-020-00814-3

American Pharmacists Association. FAQ: Pharmaceutical compounding. APhA. 2021.

https://www.pharmacytoday.org/article/S1042-0991(15)31594- 2/pdf#:~:text=Compounded%20drugs%20are%20not%20for,federal% 20law%20to%20resell%20them. Accessed November 29, 2024.

U.S. Food and Drug Administration. Insanitary Conditions at Compounding Facilities Guidance for Industry. FDA. 2020. https://www.fda.gov/regulatory-information/search-fda-guidance- documents/insanitary-conditions-compounding-facilities-guidance- industry. Accessed November 29, 2024.

Occupational Safety and Health Administration. Hazard Communication Standard (29 CFR 1910.1200). OSHA. 2024.

https://www.osha.gov/laws- regs/regulations/standardnumber/1910/1910.1200. Accessed November 29, 2024.

Occupational Safety and Health Administration. Toxic and Hazardous Substances. Occupational exposure to hazardous chemicals in laboratories. (29 CFR 1910.1450) [encompasses the implementation of a Chemical Hygiene Plan (CHP)]. OSHA. 2012. https://www.osha.gov/laws- regs/regulations/standardnumber/1910/1910.1450. Accessed November 29, 2024.

Occupational Safety and Health Administration. Personal Protective Equipment Standard (29 CFR 1910.132). OSHA. 2016.

https://www.osha.gov/laws- regs/regulations/standardnumber/1910/1910.132. Accessed November 29, 2024.

Occupational Safety and Health Administration. Bloodborne Pathogens Standard (29 CFR 1910.1030). OSHA. 2019.

https://www.osha.gov/laws- regs/regulations/standardnumber/1910/1910.1030. Accessed November 29, 2024.

United States Pharmacopeia–National Formulary. USP.

https://www.uspnf.com/. Accessed November 29, 2024.

United States Pharmacopeia. USP <800>: Hazardous Drugs—Handling in Healthcare Settings. USP. 2024. https://www.usp.org/compounding/general-chapter-hazardous-drugs- handling-healthcare. Accessed November 29, 2024.

DISCLAIMER

The information provided in this course is general in nature, and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.

Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.

Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses is constantly changing. Any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment, and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.

Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course or course material.

© RxCe.com LLC 2024: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.