What is the Origin of Pharmacy Compounding Advisory Committee?

The PCAC was officially established as a key component of the Drug Quality and Security Act (DQSA) of 2013, which was enacted in direct response to the catastrophic 2012 New England Compounding Center (NECC) tragedy. The committee was created to provide a structured, evidence-based foundation for FDA decisions regarding the ingredients and practices of both traditional compounding pharmacies (503A) and outsourcing facilities (503B). This formal structure ensures that regulatory oversight is informed by expert clinical and scientific consensus.

What is the Mechanism of Pharmacy Compounding Advisory Committee?

The committee functions by systematically reviewing scientific data, clinical necessity, and public comments on bulk drug substances nominated for inclusion or removal from the FDA's approved lists for compounding. They deliberate on the drug's clinical need, its known safety profile, and its inherent stability in various compounded formulations, often specifically addressing bioidentical hormones. Their expert recommendations guide the FDA in establishing a clear, evidence-based regulatory framework that successfully balances patient access to necessary compounded therapies with rigorous quality and safety standards.

Pharmacy Compounding Advisory Committee

Meaning

The Pharmacy Compounding Advisory Committee (PCAC) is a federal advisory body established by the U.S. Food and Drug Administration (FDA) to provide non-binding, expert scientific and clinical recommendations on drug compounding policies. This committee is composed of diverse experts in fields such as pharmacy, clinical medicine, and pharmacology, and its core function is to advise the FDA on which bulk drug substances may be used in compounding practices. Their guidance is essential for regulating the quality, safety, and necessity of compounded medications, particularly those utilized in hormonal health.

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What Are the Current FDA Designations for CJC-1295?

CJC-1295 is a synthetic peptide that is not FDA-approved due to limited clinical data and identified safety concerns.

∞ Growth Hormone
∞ Growth Hormone-Releasing Hormone
∞ 503a Bulks List

HRTioAugust 2, 2025

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What Are the Specific FDA Criteria for Peptides Eligible for Compounding?

The FDA permits peptide compounding if the substance is part of an approved drug, has a USP monograph, or is on a vetted bulks list.

∞ Metabolic Function
∞ Compounded Peptides
∞ Pharmacy Compounding

HRTioAugust 2, 2025

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What Are the Regulatory Distinctions for Compounded Peptides?

The regulatory landscape for compounded peptides hinges on whether they are made in a 503A or 503B pharmacy, which dictates oversight and safety.

∞ 503a Compounding Pharmacy
∞ Current Good Manufacturing Practices
∞ Hormonal Health

HRTioAugust 1, 2025

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How Do State Boards of Pharmacy Oversee Compounded Peptide Quality?

State Boards of Pharmacy enforce federal guidelines and USP quality standards to ensure the safety and purity of patient-specific compounded peptides.

∞ PCAB Accreditation
∞ Quality Standards
∞ Bulk Drug Substances

HRTioAugust 1, 2025

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What Are the Regulatory Considerations for Integrating Peptide Therapies in Clinical Practice?

The integration of peptide therapies requires sourcing from licensed compounding pharmacies that adhere to strict FDA bulk substance regulations.

∞ Sermorelin
∞ Pharmacy Compounding Advisory Committee
∞ CJC-1295

HRTioJuly 31, 2025

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Can Compounding Pharmacies Address Regulatory Gaps for Peptide Access?

Compounding pharmacies can provide access to certain peptides that meet strict federal criteria, operating within a precise and enforced regulatory framework.

∞ Amino Acids
∞ Peptide Regulation
∞ Pharmacy Compounding

HRTioAugust 23, 2025

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What Are the Regulatory Considerations for Personalized Hormonal Therapies?

Navigating hormonal therapy regulations means choosing between standardized, FDA-approved drugs and customized, pharmacy-compounded solutions.

∞ Clinical Trials
∞ Compounded Bioidentical Hormone Therapy
∞ FDA Regulation

HRTioJuly 26, 2025

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What Specific Peptides Are Currently Approved for Compounding?

Specific peptides like Sermorelin are approved for compounding, governed by strict FDA safety and sourcing regulations.

∞ Compounded Peptides
∞ Outsourcing Facilities
∞ Immunogenicity

HRTioAugust 23, 2025

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What Are the Regulatory Considerations for Combined Hormone and Peptide Therapies?

Navigating combined hormone and peptide therapies requires understanding the distinct regulatory pathways for patient-specific, compounded medications versus mass-market drugs.

∞ Compounding Pharmacies
∞ Pharmacy Compounding
∞ FDA Regulation

HRTioJuly 24, 2025

A human hand presents a transparent capsule with green micro-pellets. This embodies precise oral dosage for targeted peptide therapy, crucial for hormone optimization, metabolic health, and cellular function within a clinical protocol, reflecting a patient's wellness journey.

What Are the Specific Criteria for Peptide Inclusion on Compounding Lists?

The inclusion of peptides on compounding lists depends on a rigorous FDA evaluation of their chemical nature, safety, effectiveness, and historical use.

∞ 503a Compounding
∞ Food and Drug Administration
∞ Drug Compounding Safety

HRTioJuly 23, 2025

Pharmacy Compounding Advisory Committee

Meaning

Origin

Mechanism

What Are the Specific FDA Criteria for Peptides Eligible for Compounding?

What Are the Regulatory Distinctions for Compounded Peptides?

How Do State Boards of Pharmacy Oversee Compounded Peptide Quality?

What Are the Regulatory Considerations for Integrating Peptide Therapies in Clinical Practice?

Can Compounding Pharmacies Address Regulatory Gaps for Peptide Access?

What Are the Regulatory Considerations for Personalized Hormonal Therapies?

What Specific Peptides Are Currently Approved for Compounding?

What Are the Regulatory Considerations for Combined Hormone and Peptide Therapies?

What Are the Specific Criteria for Peptide Inclusion on Compounding Lists?

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