30 / 60 / 90 Launch Plan (Legal)
Put your next 90 days of legal launch work into a plan.
New client? Start with a $50 screening for fit and scope. Already approved? Review the options below.
Price: $1,900.00
New Client? Book a $50 Screening
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
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.
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.
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