THE PCCA BLOG

Best Practices for Marketing

Wed, 05 Feb 2025 15:00:00 GMT

Compounding pharmacists offer unique solutions tailored to meet specific patient needs and should have the opportunity to share these options appropriately in their communities. While promoting awareness of compounding services is vital, it’s important to thoughtfully approach how you market the services your pharmacy provides. Poorly executed marketing can attract regulatory and legal scrutiny. As such, it’s essential to understand that all marketing content, including publicly available materials, are subject to review by regulators and legal entities.

Patients, caregivers and healthcare practitioners seeking treatment options may not be familiar with the concept of compounding or the variety of ways compounding pharmacies can address specific healthcare concerns. It’s crucial that patients have access to all available treatment options and that prescribers are aware of and refer patients to compounding pharmacies that adhere with state and federal regulatory agencies. When promoting your compounding pharmacy, keep in mind the following key areas when creating or contracting marketing collateral.

Adhere to Legal and Regulatory Requirements for Compounding

Compounding pharmacists, technicians and marketers must be familiar with the requirements of the state boards of pharmacy where they are licensed. While state boards typically require compliance with the United States Pharmacopeia (USP), it’s important to note that some states may have alternative or more stringent standards. The FDA also provides various guidance documents that compounding pharmacies should be aware of — notably their Insanitary Conditions guidance. The most important aspect of these standards is patient safety. Staying up to date on compounding regulations helps minimize risks to patients and helps compounders avoid marketing noncompliant compounded preparations or practices.
Avoid Unsubstantiated Claims

Under Section 503A of the Food, Drug and Cosmetic Act, compounded human drugs are exempt from the new drug approval process. Because compounded preparations don’t undergo the FDA’s approval process for safety and efficacy, compounders should refrain from making statements suggesting that these preparations are “safe” or “effective.” It’s critical to avoid marketing materials that could be interpreted as making unsupported claims.
Conduct Thorough Marketing Reviews

Whether you choose to outsource marketing or develop materials in-house, it’s essential that all marketing content is reviewed and approved by someone with the necessary expertise. If your organization lacks this expertise, consider partnering with a legal or regulatory professional who can oversee the approval process. This precaution helps prevent potential pitfalls, such as inadvertently making unapproved claims or what may be perceived as a claim.

Resources: Best Practices for Marketing

It’s crucial that both patients and healthcare practitioners understand that compounding exists to address specific and the often-unmet needs of patients. Appropriately communicating compounding services through various marketing channels is essential — but it must be done responsibly.

The Alliance for Pharmacy Compounding (APC) has developed a detailed document outlining best practices for marketing by compounders. While these recommendations are not legal advice, they provide useful guidance to help navigate the creation of marketing materials.

Ensure your practice remains in FDA regulatory compliance by reviewing the FDA Insanitary Conditions guidance.

PCCA members with clinical services access may reach out to our Clinical Services team for help with marketing, as well as with other compounding concerns.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

Illuminating Stealth Syndromes

Wed, 29 Jan 2025 17:08:00 GMT

A forthcoming documentary from the LDN Research Trust gives compounding pharmacists, physicians and prescribers an opportunity to learn about a group of complex and debilitating syndromes that affect one in six Americans — syndromes that occur in almost every part of the body, often accompany each other and collectively exacerbate the patient’s pain and other symptoms. This article briefly summarizes these syndromes and their overlapping symptoms and discusses how you can help educate providers in your community — as well as your staff and patients — about their effects, along with the potential use of low-dose naltrexone (LDN) in compounding preparations.

Summary of Syndromes

Stealth syndromes include mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome (POTS) and Ehlers-Danlos syndrome (EDS), each of which is discussed below.

MCAS (Mast Cell Activation Syndrome)

Found in most organs of the body, mast cells are part of the immune system and are responsible for immediate allergic reactions that are triggered by allergic substances such as medications, infections, chemicals and insect bites. Mediators stored in or created by mast cells are released and create allergic reactions. A trigger from an allergen is called activation and the release of mediators is called degranulation.

MCAS is caused by dysfunction of mast cells; patients afflicted by MCAS experience repeated episodes of allergic reactions with accompanying symptoms:

Fatigue, headache, tingling, chills
Rapid pulse (tachycardia), low blood pressure (hypotension) and fainting
Itching (pruritus), hives (urticaria), swelling (angioedema) and skin flushing
Wheezing, shortness of breath and harsh noise when breathing (stridor) due to throat swelling
Diarrhea, nausea with vomiting and cramping abdominal pain^1,2

POTS (Postural Orthostatic Tachycardia Syndrome)

POTS (also referred to as dysautonomia) is caused by a malfunction in part of the autonomic nervous system, which controls involuntary body functions such as breathing and heart rate. The syndrome is considered one of a group of disorders that present symptoms of orthostatic intolerance (OI). OI is a condition where an excessively reduced volume of blood returns to the heart after an individual stands up after laying down.

Patients afflicted with POTS often experience:

Lightheadedness or fainting when standing
A rapid increase in heartbeat (more than 30 beats per minute or exceeds 120 beats per minute)
Low blood pressure
Digestive and bladder problems
Temperature and sweating dysregulation
The syndrome often prevents individuals from exercising due to onset of fainting spells or dizziness. POTS is often associated with EDS.³

EDS (Ehlers-Danlos Syndrome)

EDS is a group of disorders that affect connective tissues that support the skin, tendons, ligaments, bone, blood vessels and many organs and tissues. An unusually large range of joint movement (hypermobility) occurs in most forms and is the hallmark feature of the hypermobile type.

Patients afflicted with hypermobile EDS (hEDS) may present some or all of the following symptoms:

Joint hypermobility
Loose, unstable joints that easily dislocate
Joint pain and clicking joints
Extreme fatigue
Skin that bruises easily
Digestive problems, such as heartburn and constipation
Dizziness and an increased heart rate after standing up
Problems with internal organs, such as mitral value issues or organ prolapse (types include bladder, pelvic and rectal prolapse)
Urinary incontinence (bladder control)⁴

Compassion and Concern: The LDN Research Trust

Linda Elsegood, Chief Executive Officer and founder of the LDN Research Trust, refers to the collection of MCAS, POTS and EDS as “Stealth Syndromes.” Keenly aware of the debilitating impacts and empathetic for patients who suffer from these syndromes, Linda shared her concerns during The Mortar & Pestle podcast. “Patients with MCAS are also susceptible to having EDS and POTS; they tend to go hand-in-hand,” Linda said. “Some of these patients come into the doctor’s office with 40 different symptoms and practitioners have no idea where to start. Some physicians just throw up their hands and walk away. Others just treat one or two individual issues. But until you get down to the root cause — it’s nothing more than a Band-Aid.”

Adding insult to injury, many conventionally prescribed tests return with negative results, which add to the growing pile of doubts among family and friends.

“A lot of the tests, they do come back negative, which leads family and friends to thinking, ‘Well, if the doctors can't find anything wrong with you, there is nothing really wrong with you!’” Linda said. “I know one lady whose parents wouldn't talk to her anymore because they thought she was just a hypochondriac, that there was nothing really wrong with her. And that is so isolating for the patient.” Although considered a rare disease, Dr. Leonard Weinstock, a gastroenterologist and leading expert on MCAS, estimates one-in-six people are afflicted with the syndrome in the Northern Hemisphere; most are unaware.

During the podcast, Linda likened the lack of awareness to Lyme disease. “There were no reported cases of Lyme disease anywhere in the United States because there was no true diagnosis. And so they couldn't gather the data. And then very quickly, they said Lyme disease existed in the United States.”

Help Spread Awareness

Linda is calling on compounding pharmacists — notably PCCA members — to raise awareness of Stealth Syndromes and the potential use of low-dose naltrexone (LDN) in preparations.

The LDN Research Trust developed a documentary, “Understanding Stealth Syndromes,” that sheds light on these esoteric conditions. The documentary, which airs for 24 hours on February 27 (to accommodate global time zones), explains the underlying root causes, why most doctors miss these conditions, potential treatments and more.

Compounding pharmacies are urged to help raise awareness by:

Purchasing a documentary license — $100 for up to 50 individuals
Hosting an event at their pharmacy or a local venue
Inviting community physicians, prescribers and patients to view the documentary

“We’re aiming to raise awareness and connect individuals suffering from undiagnosed Stealth Syndromes with knowledgeable local providers,” Linda said. “Compounding pharmacists, technicians and staff are compassionate — many are aware of the benefits of LDN — and are adept at providing personalized preparations to these patients.

“They are positioned to develop awareness in their communities and can purchase as many licenses to the documentary as needed. Once we have sold the license, they can do whatever they like.”

This includes selling tickets to and/or publicizing the event on their respective pharmacy websites.

“We are happy to help them publicize or advertise the event,” Linda said. “On our website and throughout our social media platforms, we list all pharmacies who purchased licenses for the documentary, as well as their locations, so people know who to contact to attend viewings. We also hope to invite local media to these events; if an event is sold out, many become really interested and will send reporters who will broadcast or write about it.”

Watch the compelling trailer for “Understanding Stealth Syndromes”. Click Here.

To purchase one or more licenses for the documentary, Click Here.

For additional information, email contact@ldnresearchtrust.org.

Listen as Linda shares her personal struggles and the impetus for creating the LDN Research Trust, as well as the need for public awareness of Stealth Syndromes, in The Mortar & Pestle Podcast.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

References

American Academy of Allergy, Asthma & Immunology. Mast Cell Activation Syndrome (MCAS). August 2024. Accessed January 2025 at https://www.aaaai.org/conditions-treatments/related-conditions/mcas#:~:text=Idiopathic%20Mast%20Cell%20Activation%20Syndrome,are%20released%20during%20those%20episodes
POTS UK. Mast Cell Activation Syndrome. Version 3. Last reviewed July 2024. Accessed January 2025 at https://www.potsuk.org/about-pots/associated-conditions/mcas/
National Institute of Neurological Disorders and Stroke. Postural Tachycardia Syndrome (POTS). Last reviewed July 2024. Accessed January 2025 at https://www.ninds.nih.gov/health-information/disorders/postural-tachycardia-syndrome-pots
National Health Service UK. Ehlers-Danlos Syndromes. Last reviewed October 2022. Accessed January 2025 at https://www.nhs.uk/conditions/ehlers-danlos-syndromes/#:~:text=types%20of%20EDS-,Hypermobile%20EDS,with%20bladder%20control%20(urinary%20incontinence)

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.

Balance Hormones and Grow Your Practice

Thu, 19 Dec 2024 23:31:00 GMT

The numbers are in — forecasters predict 1.1 billion women worldwide will experience menopause in 2025.¹ In the U.S., more than 1 million women reach menopause each year, and more than 75 percent of these women work during menopause transition years. Research conducted by the National Institute on Aging indicates menopausal hormone therapy (MHT) reduced the severity of menopause symptoms while elevating mood, sexual function, cardiovascular and brain health.²

With all of these studies and reports, it’s no wonder that hormone replacement therapy (HRT) currently leads all compounding therapeutic areas in the U.S. — or that the U.S. HRT market value is forecasted to reach $12.6 billion within the next five years.³Maintaining up-to-date HRT knowledge is now a top priority for compounding pharmacists who support patients that experience the many side effects of perimenopause or menopause.

Introducing PCCA Master Courses: HRT

PCCA Master Courses: Hormone Replacement Therapy (HRT), a new education tool, will prepare compounding pharmacists to meet the needs of this expanding female patient segment. The dynamic platform delivers specialty education using:

Online, self-paced HRT education available on demand
Engaging, multimedia formats for interactive learning
Continuing education (CE) courses with 25 hours of CE applied for

“We understand the many nuances of compounding and recognize the varied responsibilities of compounding pharmacy owners and pharmacists,” said PCCA Director of Online Education Jerra Banwarth, RPh, FAPC. “This is why we wanted to develop a flexible program that accommodates their busy schedules. We also wanted to make it a dynamic experience to captivate and retain their interest — regardless of time or day. And we recognize the importance of specialty education — it’s an advantage that a compounding pharmacist can use to distinguish their practice from competitors.”

PCCA Master Courses: HRT was developed to be easy to follow and provides a true multimedia experience. Education is delivered through impactful audio, visual and animations, which helps learners better understand the physiological concepts of perimenopause through post-menopause.

Master Courses: HRT is composed of five courses:

Introduction to Hormones
Reviews foundational anatomy and physiology; explores the goals of HRT.
Testing and Therapy Options
Takes an in-depth look at different testing options and applications for utilization.
Clinical Evidence for HRT Patient-Centered Care
Provides insights into patient specific therapies, including dosing, routes of administration and formulations.
Bases for HRT Application
Explores appropriate bases, devices and compounding considerations for HRT formulations.
Building a Thriving HRT Compounding Practice
Provides a foundation for marketing your expertise and knowledge; offers professional recommendations on how to implement a hormone consultation practice.

Earn Your Certified Master Designation in HRT

Upon successfully completing the Master Course, learners can take their expertise further with the PCCA Certified Master* designation. The designation is achieved in two steps:

Successfully complete all courses in PCCA Master Courses: HRT by February 7, 2025.
Attend a PCCA HRT Symposium within 12 months: in-person or virtually at the Las Vegas HRT Symposium, February 20-22, or at the virtual HRT Symposium on July 24-25, 2025.

The HRT Symposium and Master Courses: HRT are complimentary educational achievements designed to help shorten the learning curve and create a powerful experience for pharmacists. In addition to increasing their knowledge, those who achieve the PCCA Certified Master designation can use it to market their practice to prescribers and patients.

“We work to ensure our education programs and symposiums benefit all attendees — from pharmacists to pharmacy technicians and medical practitioners,” said PCCA Senior Director of Education Renee Prescott. “We hire industry-expert speakers who share cutting-edge clinical research, provide ample time for participants to network and we apply for CEs, yet another benefit. More than 98 percent of participants give us an ‘A’ grade.”

Participants who achieve their initial Certified Master designation have the option to recertify by attending the PCCA HRT Symposium every two years.

“There’s always something new to learn,” said Jerra. “Serving this population not only helps women, it also benefits their families, friends, workplace and communities.”

Prepare to meet the needs of a growing market. Register today for PCCA Master Courses: HRT.

PCCA members with clinical service access may contact our Clinical Services team for additional information on compounding for HRT and other compounding concerns.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

*The Certified Master award is an internal designation provided by PCCA. It does not denote a board certification or certification by a licensed health care body. Pharmacists and practitioners are eligible for the Certified Master designation.

References

Zhang L, Ruan X, Cui Y, Gu M, Mueck AO. Menopausal Symptoms and Associated Social and Environmental Factors in Midlife Chinese Women. Clin Interv Aging. 2020;15:2195-2208. Published 2020 Nov 16. doi:10.2147/CIA.S278976
National Institute on Aging. News. Research explores the impact of menopause on women’s health and aging. Research Highlights. 2022. Accessed December 2024 at https://www.nia.nih.gov/news/research-explores-impact-menopause-womens-health-and-aging#hormone
Grand View Research. Hormone Replacement Therapy Market Size, Share & Trend Analysis By Product (Estrogen & Progesterone Replacement Therapy), By Route of Administration, By Disease Type, By Region, And Segment Forecasts, 2023 – 2030. Accessed October 2024 at https://www.grandviewresearch.com/industry-analysis/hormone-replacement-therapy-market

Hazardous Drug Wipe Sampling: Do I have to?

Thu, 05 Dec 2024 21:41:00 GMT

by Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

USP 800 discusses Environmental Quality and Control (Section 6) related to environmental wipe sampling for hazardous drug (HD) surface residue. This is not a requirement in USP 800; instead, it is stated that this should be performed routinely. What does this mean for those who handle HDs and why should compounders consider performing routine HD wipe sampling?

When handling HDs, the goal is to minimize exposure through different containment control strategies, from receiving through administration. Containment controls used in practice can be looked at as a hierarchy, with personal protective equipment (PPE) as the least effective and elimination of the HD as most effective. Elimination of HD handling is not an option in most cases, so one must utilize proper engineering controls such as negative pressure rooms, biological safety cabinets, containment ventilated enclosures and closed system transfer devices.

Other forms of containment controls include proper donning and doffing of PPE and removal of HDs through deactivation, decontamination, cleaning and disinfecting (DDCD). Containment can also be achieved through proper administrative controls such as HD communication, training and assessment of risk. Still, even if you follow all containment strategies, how do you know if they are working and that your staff and patients are not exposed?

HD wipe sampling can determine if your containment control strategies are working properly to reduce the risk of HD exposure to your team in any step of the handling processes.

What and where should I test?

USP 800 recommends HD wipe sampling be performed as a baseline at least every six months. Once you identify the areas to test, wipe sampling is a fairly simple process. It is recommended to test at various locations in your facility, starting from the time the HD enters the facility until the time it leaves. There are several companies that offer a wipe sampling kit. The contents may include a set of instructions, tubes for collection, a template to measure the area for collection and a swab used for sampling in each location. It is important to follow the instructions carefully and properly document the HDs to be tested and the corresponding areas within the facility that were swabbed.

USP 800 states the following areas should be tested when performing wipe sampling; however, it would be best to identify high-touch areas throughout the facility — again, from receiving to dispensing/administration — when possible:

Interior of the C-PEC and equipment contained in it
Pass-through chambers
Surfaces in staging or work areas near the C-PEC
Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging and dispensing area)
Areas immediately outside the HD buffer room or the C-SCA
Patient administration areas

A good place to start is to look at where HDs are handled throughout your facility. In a community pharmacy, this includes areas where patients pick up HD medications. In a health system, consider including medication rooms and patient rooms. Identify locations that have the highest touch rates to determine which areas to sample.

You also need to determine which drugs to test. Depending on the testing company you choose, you can test for a variety of drugs — from antineoplastics to hormones and even drugs such as spironolactone or finasteride. Consider testing for the HD drugs used most frequently in your facility.

What do I do with the sampling results?

Sampling results appear as a quantity if a drug is detected or listed if the drug(s) tested was not detected or present in the area sampled. Some companies color the results if a detected HD is higher than average.

If detectable contamination is found, the designated person is required to identify, document and contain the source of contamination. This can be done by creating an “environmental action plan,” a detailed document that outlines strategies and processes, including actions, timelines, responsible parties and measurable goals. Tracking and trending the wipe sampling results can drive change in your facility to contain the identified HD.

Again, there is not an established action limit for HD contamination levels, so any detectable amount will need to be addressed. Wipe sample results should be used to drive change and improve processes. Changes may include revising the DDCD process, seeking alternatives to HD storage or the use of a closed system transfer device.

Sampling data can be shared with staff to show where HD contamination is working and where it isn’t. Once you start collecting data, you will be able to keep track of sampled locations and start to trend results. The results may never reach zero, but using HD wipe sampling data should lead to a reduction in HD contamination levels.

PCCA members with clinical service access may contact our Clinical Services team for additional information on HD wipe sampling and other compounding concerns.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

Reference

United States Pharmacopeia. Online Subscription Required.

Partnerships Between 503A Pharmacies and 503B Outsourcing Facilities

Wed, 27 Nov 2024 15:31:09 GMT

by Bruno Onwukwe, PharmD Candidate, PCCA Clinical Services Intern, and Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

Sections of the FDA’s Drug Quality and Security Act (DQSA) distinguish compounding pharmacies (503A) from outsourcing facilities (503B). Due to several factors, many of which are related to drug shortages and the USP 797/USP 800 updates, 503A pharmacies are considering partnering with 503B entities for compounded sterile preparations and/or hazardous materials. We’ll discuss the differences between 503A pharmacies and 503B outsourcing facilities, review Section 503B and summarize how to effectively evaluate 503B compounding pharmacies for a potential partnership.

Key Differences

A 503A designated pharmacy may compound drugs only for an individual patient with a prescription from a qualified provider. In addition, 503A pharmacies are regulated by a state board of pharmacy, which may follow standards set by the United States Pharmacopeia (USP). In contrast, a 503B outsourcing facility does not require a prescription but must adhere to the FDA’s Current Good Manufacturing Practice (CGMP) regulations. Additional differences between 503A and 503B pharmacies related to compounding sterile and/or hazardous materials include:

Description	503A	503B
Standards	USP 797	CGMP
Regulatory Body	State Board of Pharmacy	FDA
Prescription Requirement	Yes	No
Office-Use Compounding	No	Yes
Max Batch Size	250	N/A
Release Testing	BUD Dependent	Yes
Beyond-Use Date	≤180¹	Stability Study Dependent
Interstate Distribution Limit	<5%	N/A

1. For a compounded sterile product (CSP) that has been terminally sterilized, stored frozen, passed sterility and all applicable tests for Category 3.

The 503A pharmacies that compound sterile preparations and/or hazardous materials can benefit from partnering with 503B outsourcing facilities. Forming a partnership may allow the 503A pharmacy to potentially mitigate risks, reduce operational costs, provide expanded services and improve customer satisfaction.

USP chapters 797 and 800 outline the minimum standards for sterile compounding and compounding hazardous materials. Although currently not adopted by all states, 503A pharmacies should consider implementing the USP standards as best practices in patient care and safety — even if doing so may pose challenges. USP updates include increased environmental monitoring, cleaning and disinfecting, garbing requirements, media-fill testing, personnel training, safety and more.

Wholesale Prohibitions for 503B

Section 503B(a)(8) of DQSA discusses the restrictions on wholesaling for outsourcing facilities. Compounded preparations must not be sold or transferred by an entity other than the outsourcing facility that compounded the product — wholesale distributors, pharmaceutical repackagers and relabelers, marketing firms and websites cannot participate in the sale and transfer of compounded preparations. Section 503B(a)(8) does not, however, prohibit the administration of a compounded product in a healthcare setting, nor its dispensing under a prescription.

The FDA Draft Guidance, which determines standard industry practice, clarified in June 2023 that a 503B outsourcing facility may sell its compounded products to a 503A pharmacy. Therefore, 503A state-licensed pharmacies or federal facilities may dispense compounded products in partnership with outsourcing facilities, opening the possibility of increased partnership between the two entities.

Evaluation Criteria for 503B Partnership

Many factors should be taken into consideration when deciding to partner with a 503B outsourcing facility, including:

Appropriate Licensures and Registrations — Investigate whether the 503B facility has appropriate licensure and registration within the states you intend to operate in.
Compliance with Prohibition on Wholesaling — 503As cannot buy from brokers and must directly purchase compounded products from their 503B partner. 503As, however, may use group purchasing organizations (GPOs) to negotiate contract pricing.
Quality Customer Service — Ensure the 503B facility provides reliable information for inventory, processing and shipping.
Regulatory History — Review their track record of FDA Form 483s, FMD-145s, warning letters, product recalls and other events that may call into question their conditions.

In addition, 503B outsourcing facilities must comply with CGMPs to ensure that safe, quality compounds are prepared and dispensed to patients. Some facilities have not been FDA inspected; however, evaluating the facility’s systems will help to discern CGMP compliance. An evaluation should include:

Audits
Facility Certification
Environmental Monitoring Data
Cleaning and Disinfection Program
Quality Unit
Quality Control
Standard Operating Procedures
Investigations
Personnel Training
Validation Activities
Supplier Qualification Program
Master and Batch Production Records
Equipment
Container-Closure Systems
Laboratory Controls (Method Suitability/Validation/Stability Studies)

Many 503A pharmacies that compound sterile preparations and whose state boards of pharmacy implemented USP 797 updates face a pivotal crossroad. Collaboration with a 503B outsourcing facility may pave the way toward a partnership which can increase efficiencies and free up time for pharmacists and technicians to focus efforts in different areas of patient care activities.

More information about FDA-registered outsourcing facilities can be found at https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities.

References

FDA. Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Guidance Document. June 2023. Accessed January 2024 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act
FDA. Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. Guidance for Industry. Draft Guidance. January 2020. Accessed January 2024 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-guidance-human-drug-compounding-outsourcing-facilities-under
FDA. 21 CFR Part 21 – Current Good Manufacturing Practice for Finished Pharmaceuticals. Accessed January 2024 at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
USP <797> Pharmaceutical Compounding – Sterile Preparations. 01 May 2024. Accessed January 2024 at https://doi.usp.org/USPNF/USPNF_M99925_08_01.html

GLP-1: The Naturally Produced Hormone

Wed, 04 Sep 2024 17:00:00 GMT

You’re likely familiar with semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) used in commercially available prescription medicines for treatment of type 2 diabetes and obesity. Are you aware that GLP-1 — the hormone semaglutide is designed to induce — is naturally produced by the body to help promote healthy blood sugar levels, curb cravings and maintain a healthy weight? Or aware of the bacterium in the gut microbiota that induces natural production of GLP-1?

GLP-1: Key to Blood Glucose Homeostasis

GLP-1 is part of a group of metabolic hormones — called incretin hormones — that help decrease blood glucose levels. The majority of GLP-1s are produced by L-cells lining the small intestine and colon; smaller quantities are secreted by the pancreas and the central nervous system.

In the pancreas, GLP-1 stimulates the release of insulin, increases the amount of insulin-producing pancreatic cells (beta cells) and reduces the release of glucagon — a hormone that raises blood sugar levels. GLP-1 also signals appetite centers in the brain, indicating a sense of fullness during and between meals by slowing gastric emptying.

Primarily triggered by food consumption, GLP-1 release occurs 10 – 15 minutes after eating. Although it remains in the blood system for several hours, nerve activity and other hormones can affect GLP-1 production and levels. For example, somatostatin, a hormone principally produced in the nervous and digestive systems, reduces GLP-1 production; dipeptidyl peptidase-4, an enzyme expressed on the surface of cells, terminates the blood glucose lowering action of GLP-1.^1,2

Remarkably, GLP-1 is glucose-dependent — it reduces blood glucose levels only after a person eats; it does not reduce glucose levels on its own. In clinical studies, GLP-1 administered intravenously to fasting patients failed to reduce blood sugar levels compared with patients who consumed a meal. This inability to induce hypoglycemia, or low blood sugar levels, in IV-administered GLP-1 led to the development of GLP-1 receptor agonists.²

Gut Microbiota Affects GLP-1

The human gut, commonly known as the gastrointestinal (GI) tract, possesses more than 1,000 microbial species that form a complex ecological community known as the gut microbiota. Composed of bacteria, viruses, yeast, fungi and other microorganisms, the gut microbiota plays a pivotal role in health and disease. It serves several functions, including fermentation of food, protection against pathogens, immune response stimulation and vitamin production. Composition, proportion and diversity of an individual’s gut microbiota are affected by genetics, lifestyle (diet), drugs (frequency/use of antibiotics), aging and other factors.^3-5

Microbial metabolites, such as secondary bile acids, short-chain fatty acids, lipopolysaccharide and others within the gut microbiota, trigger GLP-1 secretion. Eating certain foods — eggs, nuts (almonds, pistachios and peanuts), high-fiber grains (oats, barley and whole wheat), avocados, olive oil and vegetables (Brussels sprouts, broccoli and carrots) — has shown to support GLP-1 levels.^5-7

Multiple studies have linked gut dysbiosis — a change or imbalance in the diversity, composition and functions of the microbiota — to reduced GLP-1 levels. Reduced GLP-1 levels are directly associated with development of metabolic disorders, including type 2 diabetes and obesity.^3-8

Probiotics Support Gut Health

In addition to eating GLP-1-supportive foods, specific strains of probiotics can significantly alter the gut microbiome and increase GLP-1 production. For example, the probiotic Akkermansia muciniphila (A. municiphila) secretes a protein that induces natural production of GLP-1. A unique strain of A. municiphila, AH39, targets the mucosal layer of the gut, which is critical for retaining gut barrier integrity and promoting healthy inflammatory markers. It also promotes healthy systemic metabolic outcomes within the gut lining.^9,10

The Bifidobacterium animalis HN019 strain promotes the production of short-chain fatty acids in the gut microbiota. It also supports the intestinal barrier function and promotes healthy inflammatory markers.

The Bifidobacterium animalis B420 strain aids in weight management and supports metabolic health by influencing gut microbiota composition and promoting the production of short-chain fatty acids that support energy metabolism and contribute to GLP-1 secretion.

Lactobacillus rhamnosus GG is believed to support gastrointestinal health and immune balance. It may help promote the structural and functional integrity of the gut barrier. It also supports the composition and activity of the gut microbiome, promoting an increase in beneficial bacteria and the production of short-chain fatty acids. These actions may help maintain a healthy intestinal environment, promote healthy inflammatory markers and support metabolic functions.

Clostridium butyricum nourishes the gut lining, promotes healthy inflammatory markers and supports healthy barrier function. Clostridium butyricum 10 is known for its butyrate-producing capabilities. Butyrate is a primary energy source for colonocytes, supporting their health and promoting a robust intestinal barrier. It also supports the healthy expression of tight junction proteins, further enhancing barrier integrity.¹⁰

Many misrepresent the naturally occurring GLP-1 hormone with GLP-1 RA. It’s important, however, to recognize the distinctions. For individuals who cannot tolerate or afford GLP-1 RAs, options, including dietary food choices and probiotic nutritional supplements, are available.

References

Society for Endocrinology. Your Hormones: Glucagon-like peptide 1. Last reviewed July 2021. Accessed August 2024 at https://www.yourhormones.info/hormones/glucagon-like-peptide-1/
Nadkarni P, Chepurny OG, Holz GG. Regulation of glucose homeostasis by GLP-1. Prog Mol Biol Transl Sci. 2014;121:23-65. https://doi:10.1016/B978-0-12-800101-1.00002-8
Tomaro-Duchesneau C, LeValley SL, Roeth D, et al. Discovery of a bacterial peptide as a modulator of GLP-1 and metabolic disease. Sci Rep. 2020; 10:4922. https://doi.org/10.1038/s41598-020-61112-0
Zeng Y, Wu Y, Zhang Q, et al. Crosstalk between glucagon-like peptide 1 and gut microbiota in metabolic diseases. mBio 15:e02032-23. https://journals.asm.org/doi/10.1128/mbio.02032-23
Afzaal M, Saeed F, Shah YA, et al. Human gut microbiota in health and disease: Unveiling the relationship. Front Microbiol. 2022; 13:999001. https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.999001
Wang Q, Lin H, Shen C, et al. Gut microbiota regulates postprandial GLP-1 response via ileal bile acid-TGR5 signaling. Gut Microbes. 2023; 15(2). https://doi.org/10.1080/19490976.2023.2274124
Pederson T. What Foods Increase GLP-1 Levels? Healthline. 2024. Medically reviewed by Adam Bernstein, MD, ScD. Accessed August 2024 at https://www.healthline.com/health/foods-that-increase-glp-1
Li HY, Zhou DD, Gan RY, et al. Effects and Mechanisms of Probiotics, Prebiotics, Synbiotics, and Postbiotics on Metabolic Diseases Targeting Gut Microbiota: A Narrative Review. Nutrients. 2021;13(9):3211. https://doi:10.3390/nu13093211
Rodrigues VF, Elias-Oliveira J, Pereira ÍS, et al. Akkermansia muciniphila and Gut Immune System: A Good Friendship That Attenuates Inflammatory Bowel Disease, Obesity, and Diabetes. Front Immunol. 2022;13:934695. https://doi:10.3389/fimmu.2022.934695
Wellness Works. Metabolic Probiotic with Akkermansia Product Data Sheet. 2024. Accessed August 2024 at https://beta.pccarx.com/prod_data/10444-Metabolic-Probiotic-with-Akkermansia.pdf

Tall Man Lettering: Reducing Medication Errors

Wed, 17 Jul 2024 19:33:02 GMT

Many regulatory and nonprofit agencies, including the FDA and the Institute for Safe Medication Practices (ISMP), recommend use of tall man lettering on drug labels. Learn why PCCA is adopting the technique for our active pharmaceutical ingredient (API) labels.

According to the CDC, more than 1.5 million people in the U.S. visit emergency departments each year due to adverse drug events; almost 500,000 of those people require hospitalization.¹ Adverse events and medication errors occur due to multiple factors — from prescribing to dispensing errors; from patient nonadherence to nondisclosure of vital information. For compounding pharmacists, medication errors can occur due to look-alike, sound-alike names on drug labels.

Drug Doppelgangers Cause Confusion

ISMP, a 501c nonprofit organization, has long recognized how look-alike, sound-alike drug names contribute to medication errors. Since 2008, ISMP maintained a list of drug name pairs and trios with similar sounding or looking names with recommendations of bolded, tall man (uppercase) letters to distinguish the names of drugs.² The FDA’s Name Differentiation Project adopted ISMP’s recommended use of tall man letters — or mixed case letters — to help distinguish similar looking and similar sounding drug names.³

PCCA Adopts Tall Man Lettering

“Our culture, Core Values and Principles all focus on patient safety and quality products,” said PCCA Vice President of Clinical Services A.J. Day, PharmD. “Adopting tall man lettering will help our members’ and customers’ pharmacy staff more easily differentiate products on the shelf.”

Take, for example, medroxyprogesterone and methylprednisolone. Although the names may look and sound similar, the two APIs are prescribed for vastly different conditions.

By adopting tall man lettering, the PCCA product labels are revised: MEDROXYPROGESTERONE ACETATE USP MIC. (YAM) becomes medroxyPROGESTERone ACETATE USP MIC. (YAM); METHYLPREDNISOLONE USP MICRONIZED changes to methylPREDNISolone USP MICRONIZED (see image below).

Although use of tall man lettering has been applied to labels within our online product catalog, we are not relabeling existing stock currently on our shelves. As existing stock is depleted and new stock is repackaged, application of labels with tall man lettering will begin. Please note that some API product labels may not convert to tall man lettering for up to 18 months, depending upon expiration dates and inventory turnover.

PCCA members with clinical services access may contact our Clinical Services team for help with tall man lettering and other compounding concerns.

References

CDC. (2024) Medication Safety Program. FastStats: Medication Safety Data. Accessed July 2024 at https://www.cdc.gov/medication-safety/data-research/facts-stats/index.html
ECRI. (2024). ISMP: Institute for Safe Medication Practices. About Us. Accessed July 2024 at https://home.ecri.org/pages/ismp-about-us
FDA. (Content current as of 2020). FDA Name Differentiation Project. Accessed July 2024 at https://www.fda.gov/drugs/medication-errors-related-cder-regulated-drug-products/fda-name-differentiation-project#1

Eosinophilic Esophagitis & Compounding Options

Wed, 03 Apr 2024 15:12:31 GMT

by Matt Lester, RPh, MBA, PCCA Clinical Compounding Pharmacist, and Natalie Rea, PharmD Candidate, PCCA Clinical Services Intern

Eosinophilic Esophagitis

EoE is a chronic condition of the immune system. In patients with this condition, eosinophiles — a type of white blood cell — collect in the inner lining of the esophagus, which causes chronic inflammation.² EoE is considered a rare condition in the U.S., but prevalence has increased over the past two decades. EoE affects about 1 in 2,000 people.³ Some common symptoms include difficulty swallowing, abdominal pain, decreased appetite, nausea and vomiting. There are currently two FDA-approved treatments for EoE — a monoclonal subcutaneous (SC) injection and, now, the new oral budesonide suspension.

Corticosteroid Options

When considering oral treatments of EoE, other than budesonide, the only other recommended medication is fluticasone (another oral corticosteroid).^4,5 Oral corticosteroids help patients with EoE by reducing inflammatory cells and fibrosis. However, the caveat to using fluticasone is the only commercially available product is the inhaler. The current recommendation for fluticasone is to spray the inhaler into the mouth, let it pool, and then slowly swallow to allow the fluticasone to run down and come into direct contact with the affected tissue. The recommended dosing range in the literature is 440-880 mcg twice daily.⁴ By compounding a fluticasone suspension for patients, adherence can possibly be improved by making the medication more palatable and convenient to administer as opposed to using an inhaler.

Now that we know the oral corticosteroids used for EoE, what other compounded options can we prepare for patients who cannot tolerate commercially available drugs?

Other Compounding Options

Many patients who have EoE are already on an antihistamine (e.g., levocetirizine or ketotifen) and/or leukotriene antagonist (e.g., montelukast).⁶These medications have shown symptomatic relief in patients and could be something that can be added into a suspension to help reduce symptoms and pill burden. Antihistamines work by antagonizing the histamine receptor on mast cells to block the release of histamine and act as an eosinophil inhibitor. Leukotriene antagonists have been shown to provide symptomatic relief, which is theorized to be due to the mechanism of selectively blocking the D4 receptors of leukotrienes present in eosinophils.

Pivoting away from previously mentioned treatments, low-dose naltrexone (LDN) could be an option for EoE. Evidence shows LDN reduces inflammation and blocks pain receptors.^7,8There currently is no direct research utilizing LDN for the treatment of EoE, but LDN has been used for many inflammatory diseases such as Crohn's, MS and fibromyalgia.^9,10 There have also been some positive case reports using LDN for EoE.¹¹ EoE is primarily an inflammatory disease with a very common symptom of abdominal pain, so LDN could potentially be a promising treatment for these patients.

The goal of treating EoE is to reduce inflammation and we can do that by improving adherence of the previously mentioned APIs to the mucosal membrane of the esophagus. Keeping drugs on the mucosal surface longer can potentially enhance the effect of these medications. For oral preparations, using PCCA MucoLox™ as the base vehicle offers potential benefits not available in commercially available medications. Its one-of-a-kind polymer network provides improved moisturization, mucoadherence and superior film-forming action that won’t easily wash away. When used with APIs, its mucoadhesive properties may prolong API contact time. In addition, the oral preparation can include flavoring to make the medicine more palpable, especially for young children.¹²

Despite the increase in prevalence of EoE, it is still a poorly researched condition. While compounded medications represent a valuable option, they should be considered with a comprehensive treatment approach that includes dietary modifications, lifestyle adjustments and regular monitoring. The more we understand EoE, the easier it gets to spot and treat. This means earlier diagnosis, better care and a more dependable treatment regimen.

PCCA members may access our PCCA Science technical reports for MucoLox on the Members-Only Website. Members with clinical services access may search our formulation database for oral formulas using MucoLox, as well as contact the PCCA Clinical Services team for help with compounding preparations for EoE patients.

References

Takeda. (2024) EOHILIA ™ Prescribing Information. Accessed March 2024 at https://content.takeda.com/?contenttype=PI&product=EOH&language=ENG&country=USA&documentnumber=1
Roussel, J.M., Pandit, S. (updated 2023). Eosinophilic Esophagitis. StatPearls Publishing, Treasure Island (FL). Accessed March 2024 at https://www.ncbi.nlm.nih.gov/books/NBK459297/
NORD. (updated 2024.) Eosinophilic Esophagitis. Accessed March 2024 at https://rarediseases.org/rare-diseases/eosinophilic-esophagitis/
Hirano, I., Chan, E.S., Rank, M.A., et al. (2020) AGA institute and the joint task force on allergy-immunology practice parameters clinical guidelines for the management of eosinophilic esophagitis. Ann Allergy Asthma Immunol.124(5):416-423. Accessed March 2024 at doi:10.1016/j.anai.2020.03.020
Nennstiel, S., Schlag, C. (2020). Treatment of eosinophlic esophagitis with swallowed topical corticosteroids. World J Gastroenterol. 26(36):5395-5407. Accessed March 2024 at doi:10.3748/wjg.v26.i36.5395
Dellon, E.S., Jensen, E.T., Martin, C. et al. (2014) Prevalence of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol.12(4):589-96.e1. Accessed March 2024 at doi:10.1016/j.cgh.2013.09.008
Patten, D.K., Schultz, B.G., Berlau, D.J. (2018) The Safety and Efficacy of Low-Dose Naltrexone in the Management of Chronic Pain and Inflammation in Multiple Sclerosis, Fibromyalgia, Crohn's Disease, and Other Chronic Pain Disorders. Pharmacotherapy.38(3):382-389. Accessed March 2024 at doi:10.1002/phar.2086
Toljan, K., Vrooman, B. (2018) Low-Dose Naltrexone (LDN)-Review of Therapeutic Utilization. Med Sci (Basel). 6(4):82. Accessed March 2024 at doi:10.3390/medsci6040082
Schroeder, S., Atkins, D., Furuta, G.T. (2010) Recent advances in the treatment of eosinophilic esophagitis. Expert Rev Clin Immunol. 6(6):929-937. Accessed March 2024 at doi:10.1586/eci.10.65
Parkitny, L., Younger, J. (2017 ). Reduced Pro-Inflammatory Cytokines after Eight Weeks of Low-Dose Naltrexone for Fibromyalgia. Biomedicines.;5(2):16. Accessed March 2024 at doi:10.3390/biomedicines5020016
SKCSnowmass. (2022) EOS Connections, Eosinophilic Esophagitis (EoE) Accessed March 2024 at https://www.inspire.com/groups/eos-connections/discussion/low-dose-naltrexone-for-eoe/
Song. G., Banov, D., Bassani, A.S., Valdez, B.C. (2017) Evaluation of the Safety, Cell Migration, and Mucoadhesive Properties of a Mucoadhesive Polymer Blend in Human Oral Mucosa. AAPS PharmSciTech. 18(5):1617-1623. Accessed March 2024 at doi:10.1208/s12249-016-0630-z

$27/Day Delivers Comprehensive Support

Wed, 13 Mar 2024 15:38:09 GMT

PCCA’s Clinical Services team responded to well over 45,000 calls from our members in 2023, assisted in more than 300 formulation developments, presented at 30 Speaker Bureau educational sessions and 39 PCCA training events, plus much more. In January 2024, they responded to approximately 4,500 calls with a satisfaction rating of 100 percent and an average resolution time of under 35 minutes (the average resolution time depends on the amount of calls received and may not always remain under 35 minutes). Data, however, does not truly reflect the behind-the-scenes, comprehensive and multi-departmental collaboration our Clinical Services team delivers to compounding pharmacies and the patients they serve. Nor does the data reflect the sincere gratitude and appreciation expressed by PCCA members with clinical services access.

You have a true treasure on your Clinical Services team! Don is a wealth of information, which he shares readily. I have enjoyed speaking with him over many years. Thank you!
— PCCA Member, January 2024

Formulation Development: Content Evaluation to Collaboration

Content evaluation focuses on ensuring the accuracy of clinical information contained in all presentations provided by various speakers, long before a seminar or educational event occurs. More importantly, it also involves assessing opportunities for new formula development.

For example, during a recent presentation review, a PCCA clinical compounding pharmacist noticed a specific formula requested by a doctor was not included in the PCCA formulation database. Our pharmacist contacted the member pharmacy that was developing the preparation and learned help was needed to resolve some formula issues. Shortly thereafter, our pharmacist reached out to the PCCA Formulation Development team. Through discussions and testing, they recognized incompatibilities between the active pharmaceutical ingredients (APIs) contained in the original formulation. To rectify the issue, two separate formulas were created for simultaneous use, which eliminated incompatibility issues while addressing the physician’s original request. The collaborative nature between our Clinical Services and Formulation Development teams resolved a member-specific issue and created new formulations in the PCCA database, while ensuring seminar attendees had access to formulas and comprehensive information before the speaker walked onto the stage.

Deborah was very helpful! Our hospice doctor was very pleased with her suggestions and we are working on a formula for his patient.
— PCCA Member, January 2024

Collaboration Enables Comprehensive Support

By interacting with our compounding pharmacy members throughout various PCCA programs — including Concierge Compounding, Advisory Council and multiple PCCA Education events — our Clinical Services team often uncovers unmet patient needs that, in turn, help facilitate new product development at PCCA. In addition to sharing member insights with our R&D team, our Clinical Services team aids in product development by gathering additional information.

For example, during the development of SuspendIt^® Anhydrous, members of our Clinical Services team reached out to various healthcare specialists to understand how our new anhydrous suspension vehicle may help their patients. By sharing this information with other PCCA teams, our Science team knew to create case studies evaluating the use of SuspendIt Anhydrous in feeding tubes for hospice, geriatric and pediatric patients. Our Formulation Development team knew which formulations — including flavors — to develop and test. Our Clinical Services team members with expertise in animal care researched and shared the animal species that would best tolerate SuspendIt Anhydrous and those that are not good candidates.

In addition to the expert guidance PCCA Clinical Services team members provide daily for patients with specific conditions — from autism spectrum disorders to autoimmune diseases and beyond . PCCA members with clinical services access can also rely on this team for business and marketing support, as well as guidance on regulatory changes that impact community pharmacy.

Watch a short video, featuring PCCA Compounding Pharmacist Mark Gonzalez, PharmD, for a glimpse of A Day in the Life of a Clinical Services team member.

USP 800: Is It Enforceable?

Wed, 10 Jan 2024 22:42:05 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

Sections of the United States Pharmacopeia (USP) that don’t get enough attention are the General Notices. USP General Notices describe how the USP works. For example, this particular notice has shaped the applicability of USP 800:

“Applicable general chapters” means general chapters numbered below 1000 or above 2000 that are made applicable to an article through reference in General Notices, a monograph, or another applicable general chapter numbered below 1000.¹

Until recently, USP 800 was an official chapter within USP but wasn’t considered “compendially applicable” because it wasn’t referenced in the General Notices, a monograph or another applicable general chapter numbered below 1000. However, on November 1, 2023, revisions to USP Chapter 795 and Chapter 797 became official. USP 795 and 797 are applicable general chapters that reference USP 800, which make USP 800 compendially applicable and potentially enforceable.

To determine if USP 800 is enforceable in your practice, you need to know which state or states your pharmacy is licensed in and know the related state board of pharmacy requirements. In my review of state regulations, more than 30 states have language generally requiring compliance with USP when compounding. This general language would require compliance with USP 795, 797 and 800.

Alternatively, some states are not allowed to adopt items by reference in their regulations. In other words, some states cannot simply say, “Follow USP,” but are required to write their own regulations. Some of those states write regulations that closely mirror USP chapters, but those state regulations may differ from USP. A few states have requirements that are more stringent than USP 795, 797 and 800. Other states are still considering USP 800 and will make their decisions at some point in the future. Several states have also delayed enforcement of USP 795, 797 and 800 for one to two years.

A few resources may help you understand where your state board of pharmacy is on these topics, such as state board of pharmacy websites, newsletters and the “law book” of each state. Calling a state board of pharmacy or inspectors for information — notably with mixed results — may produce a productive result. Another resource available to members of the Alliance for Pharmacy Compounding (APC) is their Compilation of State-Adopted USP 795, 797 and 800 Rules. Please note that use of this resource requires APC membership.

If you’ve researched the potential enforcement of USP 800 where your pharmacy is licensed and found that it’s not currently being enforced, you may think that nothing needs to be done when compounding hazardous drugs. However, the FDA does.

The FDA releases its thoughts on a variety of topics through what they call guidance documents. The preface in the agency’s Guidance for Industry, Insanitary Conditions at Compounding Facilities states:

This guidance represents the current thinking of the Food and Drug Administration (FDA or the Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.

The guidance initially says that it’s not binding on the FDA or the public — which might make you think it’s not important — to the contrary, that guidance is a critical resource for understanding FDA’s thoughts and expectations during the agency’s inspections of compounding facilities, independent of whether or not any particular USP chapters are enforced by the state board of pharmacy. The guidance specifically calls out the handling of hazardous drugs, including sensitizing or highly potent drugs:

Handling bulk drug substances or drug products that are hazardous, sensitizing, or highly potent (e.g., hormones) with inadequate controls to prevent cross-contamination. This includes:

inadequate dedication, segregation, and containment (e.g., a powder-containment hood) of a suite, room, or piece of equipment based on risk;
inadequate cleaning of rooms, work surfaces, and equipment (e.g., utensils), including spills;
inadequate segregation of HVAC systems (as appropriate for the operation); and
inadequate control over the movement of personnel and materials.

Other federal agencies, including the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH), are involved in protecting compounding pharmacy staff from potential exposure to hazardous drugs.

USP 800 may or may not be enforced by your board or boards of pharmacy, despite being an official chapter that is now compendially applicable within the USP. Regardless of a board of pharmacy’s position, the FDA, OSHA and NIOSH are interested in preventing the potential for cross-contamination of hazardous, sensitizing and highly potent drugs on patients and compounding pharmacy staff.

The FDA rarely, if ever, references a USP chapter in inspection reports for compounding pharmacies. The state’s position on USP 800 does not affect the FDA’s approach to preventing insanitary conditions from existing in compounding facilities. Nor does the state’s position affect OSHA regulations.

Members with clinical services access may contact our Clinical Services team for help with compounding sterile and nonsterile formulations in compliance with USP Chapters 795, 797, 800 and the FDA’s Insanitary Conditions Guidance, as well as other compounding concerns.

References

United States Pharmacopeia. Online Subscription Required.

THE PCCA BLOG

Best Practices for Marketing

Adhere to Legal and Regulatory Requirements for Compounding

Avoid Unsubstantiated Claims

Conduct Thorough Marketing Reviews

Resources: Best Practices for Marketing

Illuminating Stealth Syndromes

Summary of Syndromes

MCAS (Mast Cell Activation Syndrome)

POTS (Postural Orthostatic Tachycardia Syndrome)

EDS (Ehlers-Danlos Syndrome)

Compassion and Concern: The LDN Research Trust

Help Spread Awareness

Watch the compelling trailer for “Understanding Stealth Syndromes”. Click Here.

To purchase one or more licenses for the documentary, Click Here.

References

Balance Hormones and Grow Your Practice

Introducing PCCA Master Courses: HRT

Earn Your Certified Master Designation in HRT

References

Hazardous Drug Wipe Sampling: Do I have to?

What and where should I test?

What do I do with the sampling results?

Reference

Partnerships Between 503A Pharmacies and 503B Outsourcing Facilities

Key Differences

Wholesale Prohibitions for 503B

Evaluation Criteria for 503B Partnership

References

GLP-1: The Naturally Produced Hormone

GLP-1: Key to Blood Glucose Homeostasis

Gut Microbiota Affects GLP-1

Probiotics Support Gut Health

References

Tall Man Lettering: Reducing Medication Errors

Drug Doppelgangers Cause Confusion

PCCA Adopts Tall Man Lettering

References

Eosinophilic Esophagitis & Compounding Options

Eosinophilic Esophagitis

Corticosteroid Options

Other Compounding Options

References

$27/Day Delivers Comprehensive Support

Formulation Development: Content Evaluation to Collaboration

Collaboration Enables Comprehensive Support

USP 800: Is It Enforceable?

References