Drug & Pharmacy FDA Regulatory Counsel: Compounding, DSCSA and OTC

FDA Regulatory Counsel for Pharmacies, Compounders and Drug Companies

Pharmacy is one of our core industries. That experience carries into FDA drug regulation, where pharmacies, outsourcing facilities, wholesalers and drug brands face federal rules that sit on top of state licensing and DEA requirements.

Compounding: 503A Pharmacies and 503B Outsourcing Facilities

Whether a product may be compounded, including bulk substance lists, the limits on copies of commercially available drugs, and drug shortage rules.
Prescription and office-use questions, interstate distribution and state nonresident pharmacy licensing.
503B registration, product reporting and cGMP expectations for outsourcing facilities.
Marketing of compounded drugs, including telehealth partnerships. See our page on compounded GLP-1 compliance.

Drug Supply Chain Security Act (DSCSA)

We help dispensers, wholesale distributors and third-party logistics providers meet DSCSA requirements for authorized trading partners, transaction data, verification and suspect product investigations. In August 2026 FDA extended its exemption for qualifying small dispensers to November 27, 2027, with size measured as of November 27, 2026. Pharmacy groups with several locations or affiliated owners should confirm whether they qualify before relying on it.

OTC Drugs and Drug Marketing

OTC monograph compliance, Drug Facts labeling and registration and listing.
Reviewing claims that could turn a cosmetic, supplement or wellness product into an unapproved drug.
Advertising and website review for pharmacies, telehealth companies and drug brands.

Inspections, Boards of Pharmacy and Enforcement

We represent pharmacies and drug companies in FDA inspections, Form 483 and warning letter responses, and state board of pharmacy investigations and hearings. See FDA enforcement defense and our pharmacies and pharmacy organizations practice.

Talk to Us

If you operate a pharmacy, outsourcing facility, wholesaler or drug brand and have a compounding, DSCSA, labeling or inspection question, contact us for a confidential consultation.

A 503A pharmacy compounds for identified individual patients based on prescriptions and is mainly regulated by its state board of pharmacy. A 503B outsourcing facility registers with FDA, may compound without patient-specific prescriptions, must follow federal current good manufacturing practice, and is inspected by FDA on a risk basis. Each section has its own limits on which drugs and bulk substances may be used.