PCAB Accreditation as a Safety Net: GLP-1 Demand and the Spotlight on Compounding Standards

Compounded medications can offer customized formulations for individual patients or address the shortage of a commercial drug. However, as demand for compounded drugs rises, so do concerns about safety, quality, and regulatory oversight—particularly with the increasing prevalence of direct-to-consumer (DTC) advertising that creates demand for ancillary or off-label uses for particular medications. Ensuring the safety and consistency of these medications makes accreditation a crucial factor in upholding the integrity of compounding practices.

The Rise of Compounded Drugs and Patient Risks

Compounded drugs differ from the prescription medications available under brand names and even generic formulations because they are not subject to the traditional FDA premarket approval process. The FDA monitors drug shortages and maintains a list of these pharmaceuticals, which then become eligible for production by compounding pharmacies. Although the United States Pharmacopeia and state boards of pharmacy provide oversight, the FDA does not regulate compounded drugs as it does manufactured medications. This leaves potential gaps in quality control, consistency, and safety.

A striking example of the need for responsible oversight in compounding is the off-label prescribing and compounding of glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide (Ozempic, Wegovy). Originally approved for diabetes and heart disease, these drugs quickly gained popularity for their weight loss benefits.

A recent study found that 1 in 8 Americans has used a GLP-1 medication, with 62% for diabetes or heart disease and 40% for weight loss.¹Another survey of physicians revealed that nearly 9 in 10 expect GLP-1 prescriptions to at least double this year, with the majority anticipating an increase of 3.5 times or more.² This surge in demand led to supply shortages, which opened the door for compounded versions of these medications—raising serious concerns.

According to a survey of health care providers³:

• Forty-two percent of physicians advise against using compounded GLP-1 drugs for weightloss due to concerns about safety, quality, and regulatory inconsistencies.
• Over 100 telehealth platforms actively market compounded GLP-1 medications, often without robust patient-physician relationships or appropriate medical oversight.

Unlike FDA-approved drugs, compounded medications may:

1. Lack standardization, leading to inconsistent dosages and variable potency,
2. Contain unverified active ingredients that may not match those in brand-name medications, and
3. Be produced in facilities with varying levels of quality control and sterility measures.

The FDA has received numerous reports of adverse events related to compounded GLP-1 drugs, particularly when incorrect dosages or formulation inconsistencies were present.⁴

Consumer Ads and the Boom in DTC Compounded Medications

Injectable treatment pen. Image Credit: © Edugrafo - stock.adobe.com

The rise of DTC marketing for GLP-1s has further complicated the issue. Hims & Hers, a well-known telehealth platform, ran an ad during the Super Bowl this past February for these medications as a weight loss solution, triggering an unprecedented surge in online traffic and consumer interest.⁵

Hims & Hers saw its stock value surge over 200% in a month due to its semaglutide offerings, but shortly after, the FDA removed semaglutide from the official drug shortage database.⁵ The FDA gave April 22, 2025, as the date beyond which these drugs can no longer be legally compounded.⁶ This highlights the complex regulatory landscape surrounding compounded medications and the potential public health risks associated with their uncontrolled distribution.

Why PCAB Accreditation Is More Important Than Ever

The Pharmacy Compounding Accreditation Board (PCAB), a service of ACHC, has long represented the benchmark of quality for compounders.⁷ PCAB accreditation is a critical safeguard, ensuring compounded medications meet stringent quality and consistency standards.⁷ PCAB-accredited pharmacies must comply with the following⁷:

1. Comprehensive quality controlmeasures to maintain consistency in compounded formulations;
2. Contamination prevention protocols for both sterile and nonsterile compounding, and sterility for sterile compounding; and
3. Proper training and oversight to ensure pharmacists and technicians follow best practices.

Furthermore, PCAB accreditation supports patient safety by ensuring that compounded medications are dispensed responsibly—ideally within the context of an established patient-physician relationship.⁶ By undergoing rigorous evaluation and oversight, PCAB-accredited pharmacies demonstrate their commitment to best practices in sterile and nonsterile compounding. Without proper oversight, compounded medications can pose significant risks to patients due to inconsistencies in potency, contamination risks, and improper formulation.

Future of Compounded Medications: Balancing Innovation With Safety

The compounding pharmacy industry is at an important crossroads. Although personalized medicine is a welcome new frontier and drug shortages drive demand for compounding existing formulations, ensuring the quality, safety, and integrity of compounded drugs must remain a top priority.

PCAB accreditation provides pharmacies with the framework needed to meet these challenges while reinforcing public trust in compounded medications. As health care evolves, patients and providers alike must recognize the importance of seeking out accredited pharmacies to ensure that compounded medications are safe, effective, and consistently produced.

With the growing popularity of DTC advertising—particularly in weight loss and specialty treatments—ensuring responsible oversight has never been more essential. PCAB accreditation remains the gold standard for compounding pharmacies, helping protect patients and maintain the industry’s integrity.

As the regulatory landscape continues to shift, ACHC remains committed to supporting accredited pharmacies and advocating for higher standards in compounding.

REFERENCES

1. Montero A, Sparks G, Presiado M, Hamel L. KFF health tracking poll May 2024: the public’s use and views of GLP-1 drugs. KFF. May 10, 2024. Accessed June 6, 2025. https://www.kff.org/health-costs/poll-finding/kff-health-tracking-poll-may-2024-the-publics-use-and-views-of-glp-1-drugs/

2. Virta Health. Physicians say GLP-1s are imperfect, not “silver bullet” to solve obesity crisis. Fierce Healthcare. August 5, 2024. Accessed June 5, 2025. https://www.fiercehealthcare.com/sponsored/physicians-say-glp-1s-are-imperfect-not-silver-bullet-solve-obesity-crisis

3. Landi H. Primary care doctors concerned about telehealth GLP-1 boom: survey. Fierce Healthcare. February 13, 2025. Accessed June 6, 2025. https://www.fiercehealthcare.com/providers/primary-care-doctors-concerned-about-patient-risks-telehealth-prescribers-glp-1s-survey

4. Mattingly TJ, Conti RM. Marketing and safety concerns for compounded GLP-1 receptor agonists. JAMA Health Forum. 2025;6(1):e245015. doi:10.1001/jamahealthforum.2024.5015

5. Gatlin A. Behind Hims stock’s roller-coaster ride as weight-loss drugs battle heats up. Investor’s Business Daily. February 28, 2025. Accessed June 5, 2025. https://www.investors.com/news/technology/hims-stock-hims-hers-health-semaglutide-shortage/

6. Kindelan K. Compound versions of some weight loss drugs to be restricted. ABC News. March 11, 2025. Accessed June 6, 2025. https://abcnews.go.com/GMA/Wellness/compound-versions-weight-loss-drugs-longer-fda-rules/story?id=119665010

7. Include all staff in survey preparation. Accreditation Commission for Health Care Inc. November 28, 2022. Accessed June 5, 2025. https://achc.org/compounding-pharmacy-include-all-staff-in-survey-preparation/