Compounded Peptide Federal Status Assessment

Know where each peptide on your formulary stands under federal compounding law.

Price range: $1,100.00 - to $4,475.00

Single Substance

Formulary Review (up to 10)

$1,100.00

$4,475.00

Buy Now Add To Cart

Ideal For:
503A pharmacies and 503B outsourcing facilities that are deciding whether to add, keep, or pause peptide preparations as FDA’s list, rulemaking, and enforcement positions change.

Includes:

• Federal status analysis for each substance: 503A bulks list category, USP or NF monograph status, approved-drug component status, the 503B bulks list, and the “essentially a copy” limits
• Review of the route of administration, dosage form, and any substance-specific limits
• A status table showing whether each substance is authorized now, pending, restricted, or unclear, with the specific legal event that would change its status
• Formulary Review adds a risk-ranked action plan and a 45-minute briefing call

Excludes:

• State board of pharmacy law, licensing, or inspection requirements (coordinate with state-licensed counsel)
• USP 795/797/800 technical or facility compliance
• Clinical, safety, or efficacy opinions
• Ongoing monitoring after delivery (see Peptide Regulatory Watch Retainer)
• DEA or controlled-substance analysis

Deliverables:
A written status memo and status table. The Formulary tier also includes the action plan and briefing call.

Typical Turnaround:
Single Substance 1 week. Formulary Review 2–3 weeks.

Check the exact scope before paying

·      Review the product’s current fee, prerequisites, and exclusions.

·      Any custom or expanded work needs a separate written scope and fee.

·      Representation begins after conflicts clear and a signed engagement letter is in place.

Attorney advertising. Prior results do not guarantee a similar outcome.