Access without approval: state-level determinants of peptide availability in sexual medicine

Despite increasing use of peptides in sexual medicine, interstate differences in access are not fully explained by federal approval status and may instead reflect variation in state-level healthcare delivery structures.

To systematically compare state-level environments affecting access to peptide-based sexual medicine therapies using objective proxy measures and to generate a clinician-friendly framework for identifying geographic disparities.

We conducted a cross-sectional, state-level analysis of all 50 U.S. states and the District of Columbia. Access environments were characterized using three reproducible proxy variables reflecting clinical feasibility of care: (1) telehealth prescribing permissiveness, (2) nurse practitioner (NP) practice authority, and (3) availability of FDA-registered 503B outsourcing facilities normalized by population. Each variable was coded on a standardized scale and averaged to generate a compositive Peptide Access Environment Score (PAES). States were stratified into high-, moderate-, and low-access tiers. Regional differences were evaluated using nonparametric statistical testing and geographic visualization.

Primary outcomes included state-level PAES values and access tier classification. Secondary outcomes included regional variation and concordance between telehealth regulation and compounding infrastructure.

PAES values ranged from 0.33 to 1.56, demonstrating substantial interstate variability. High-access environments clustered predominantly in the Northeast and West, while low-access states were most frequently observed in the South and parts of the Midwest. Regional differences in PAES were statistically significant (p < .001). Discordance between telehealth prescribing permissiveness and compounding infrastructure was identified, with multiple states permitting telehealth initiation of care despite lacking in-state 503B facilities, and others possessing compounding capacity but maintaining restrictive telehealth regulations.

State-level healthcare delivery policies and infrastructure may meaningfully influence patient access to peptide-based sexual medicine therapies independent of peptide-specific regulatory status.

Strengths include a transparent, reproducible methodology using publicly available data and a clinically grounded, multidimensional access framework. Limitations include reliance on proxy measures, exclusion of physician assistant autonomy, and inability to assess within-state socioeconomic or urban-rural heterogeneity.

Interstate differences in telemedicine permissiveness, NP practice authority, and compounding infrastructure are associated with significant geographic disparities in access to peptide-based sexual medicine therapies in the United States.