To request samples of Invega Sustenna, a licensed prescriber submits a written Invega Sustenna sample request form to Janssen, either by handing it to a pharmaceutical representative, mailing or faxing it to the manufacturer, or submitting it through Janssen’s healthcare provider portal. The form itself is short. What makes or breaks the request is whether every field required by 21 CFR 203.30 is filled in correctly and whether the person signing it has active prescribing authority in the state.
Who Can Sign the Request
Only practitioners licensed to prescribe Invega Sustenna may request samples. Under 21 CFR 203.30, a manufacturer or authorized distributor may ship a sample by mail or common carrier only after the practitioner submits a written request and the manufacturer verifies the practitioner’s license with the appropriate state authority.1eCFR. 21 CFR 203.30 – Sample Distribution by Mail or Common Carrier In practice, that means physicians (MD and DO), nurse practitioners, and physician assistants with active prescribing authority.
Invega Sustenna is not a controlled substance, so no DEA number is needed on the form.2DailyMed. INVEGA SUSTENNA – Paliperidone Palmitate Injection A state license or authorization number is sufficient. The DEA number requirement under 21 CFR 203.30(b)(1)(ii) applies only to scheduled drugs.
What the Form Must Contain
Federal rules spell out exactly what the written request has to include. Missing any one of these gives Janssen grounds to reject or delay the shipment. Per 21 CFR 203.30(b)(1), the form must carry:1eCFR. 21 CFR 203.30 – Sample Distribution by Mail or Common Carrier
- The practitioner’s name, address, and professional title. Use the clinical office address, since credentials are verified against state records and the samples ship to the address on the form.
- The practitioner’s signature. A handwritten signature is standard; the federal rule names no electronic shortcut.
- The state license or authorization number. This is the state medical license, not the NPI.
- The drug name and strength. Write “Invega Sustenna (paliperidone palmitate)” and the exact strength or strengths requested.
- The quantity requested at each strength, by number of pre-filled syringes.
- The manufacturer’s name, Janssen Pharmaceuticals, Inc., and if going through an authorized distributor, that distributor’s name as well.
- The date of the request.
If the samples are shipping to a hospital pharmacy rather than directly to the practitioner’s office, add the pharmacy’s name and address to the form.1eCFR. 21 CFR 203.30 – Sample Distribution by Mail or Common Carrier
Choosing Strengths and Quantities
Invega Sustenna is supplied as pre-filled syringes in five strengths: 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg.2DailyMed. INVEGA SUSTENNA – Paliperidone Palmitate Injection The standard initiation regimen is 234 mg on day one and 156 mg one week later, both in the deltoid. Monthly maintenance doses then range from 39 mg to 234 mg depending on indication and response.3J&J Labels. INVEGA SUSTENNA Prescribing Information
The recommended schizophrenia maintenance dose is 117 mg monthly, with lower or higher doses used for some patients. Schizoaffective disorder maintenance doses typically run 78 mg to 234 mg.4J&J Medical Connect. Dosing of INVEGA SUSTENNA – Rationale – Maintenance Dose Most prescribers requesting samples list the 234 mg and 156 mg strengths for initiation plus the maintenance strength they expect to use.
How to Submit It
The traditional route is through a Janssen pharmaceutical representative. The rep can provide the form, pick it up when completed, and handle submission. When a rep hands samples over in person instead of shipping them, the regulatory framework shifts to 21 CFR 203.31, but the information required on the request form is the same.5eCFR. 21 CFR 203.31 – Sample Distribution by Means Other Than Mail or Common Carrier
The second route is Janssen’s online professional portal. Johnson & Johnson runs a healthcare provider hub where registered prescribers can manage sample requests digitally after creating an account and verifying their credentials. The current entry point is the Invega Sustenna HCP website at invegasustennahcp.com, or Janssen’s medical affairs team can direct you to it.
For requests sent by mail or fax, keep a copy in the office file. Janssen is required to retain request forms for three years, and a parallel copy on your end is useful if an auditor ever has questions.6eCFR. 21 CFR Part 203 – Prescription Drug Marketing
What Happens After You Submit
Before anything ships, the manufacturer must verify with the state licensing authority that the requesting practitioner is currently licensed to prescribe the drug.1eCFR. 21 CFR 203.30 – Sample Distribution by Mail or Common Carrier This step is mandatory. A lapsed, suspended, or restricted license means the request is denied.
When the samples arrive, someone has to sign a written receipt. The receipt, provided by the manufacturer, has to include the name, address, professional title, and signature of the practitioner or a designee accepting delivery, along with the drug name and strength, the quantity delivered, and the delivery date.5eCFR. 21 CFR 203.31 – Sample Distribution by Means Other Than Mail or Common Carrier The signed receipt goes back to the manufacturer or distributor. Skipping it puts both sides out of compliance.
Keep Records at Your Office
Beyond the signed receipt, a short internal log is the simplest way to stay on top of samples once they are in the building. Note the date each sample arrived, the strength and quantity, and the date and patient to whom it was administered. Janssen must retain its own request forms, receipts, and related records for at least three years and produce them to FDA on request.6eCFR. 21 CFR Part 203 – Prescription Drug Marketing A matching log on the practitioner side closes the loop and makes any later question easy to answer.
Penalties for Misusing the Sample Process
The sampling framework carries real consequences for abuse. Under 21 USC 333(b)(1), knowingly selling, purchasing, or trading drug samples, or offering to do so, is punishable by up to 10 years in prison, a fine of up to $250,000, or both. A manufacturer or distributor whose sales representative is convicted of illegal sample trading faces civil penalties of up to $50,000 per violation for the first two convictions within any ten-year period and up to $1,000,000 per violation after that.7Office of the Law Revision Counsel. 21 USC 333 – Penalties For an individual prescriber, poor record-keeping or diversion can mean loss of sampling privileges, state board action, or federal referral.