OHSRP COVID-19 Response Hub / Clinical Center/Pharmacy information regarding COVID-19 / COVID-19-CC/Pharmacy 1

Guideline for special requests for Investigational Drug Shipment related to the study participants’ inability to travel to the NIH during COVID-19 outbreak

INVESTIGATIONAL DRUG SHIPMENT REQUEST

This guideline is only applicable to Investigational Drugs managed by the NIH Pharmacy Department’s Investigational Drug Control Unit (IDCU). They include drugs under INDs, drugs under IND-exemption but labelled as for investigational use and drugs for double blind studies etc. Refer to Section C for international shipment.

A. Request for Shipping Investigational Drugs, Self-Administered by Patients, to Patients within the United States:

Continue to order through CRIS.
- Include shipping information in the Comment to Pharmacy section of the order. Make sure that address and contact information is current.
- Send sponsor authorization for shipment to patients (if applied) to CC-PHARIDCU@mail.nih.gov
- For Cancer Therapy Evaluation Program (CTEP) sponsored products, refer to the March 16, 2020 - Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP) https://ohsrp.irbo-stage.nih.gov/confluence/display/ohsrp/COVID-19
Enter CRIS order at least two days prior to the dose start date to allow outpatient pharmacy process orders and shipment.
Outpatient Pharmacy will ship the drug to the patient based on Rx according to CCP.5004-1. Mailing out outpatient orders (PDF)
Pharmacy does not provide auxiliary supplies (e.g. needles) to the patients. However, if the study team brings them to outpatient pharmacy, pharmacy can include them together in the shipment.

B. Request for Shipping Administered in a Healthcare Setting, to a Non-study Location within the United States:

Please refer to the instructions for off-site drug administration from IRB.

Due to special requirements related to the shipment of investigational agents, it is highly encouraged that the sponsor/manufacturer ships the product directly from their depot to destination site(s). If such an arrangement is made, inform the lead pharmacist in IDCU for your protocol so that necessary documents (Drug Fact Sheet, worksheets etc.) can be sent to alternate site.

It is preferable that the destination site has an investigational drug pharmacy. For drugs requiring sterile compounding, pharmacy can ship the drug only to a hospital pharmacy where they are compliant to the USP 797.

If the NIH Pharmacy (IDCU) is required to send the drug to an alternate site, please see below.

B.1 Information pharmacy must have from the PI

Please fill out the table below and related documents. Send information to IDCU (Investigational Drug Control Unit) at CC-PHAR IDCU CC-PHARIDCU@mail.nih.gov at least one week if possible prior to the planned dose administration date:

Documentation of authorization from the study sponsor to deviate from the protocol
The protocol number
The investigational drug name, dose, frequency
The participant name and MRN (encrypt the email)
The destination site name, shipping designee information, including PI and the site pharmacist contact, address and phone number
Quantity of drug to be shipped
Filled out form NIH-1884 (All fields must be typed-in, not hand-written.)
IRB approval letter for planned deviation

B.2 NIH pharmacy (IDCU) will provide the following information to the destination site:

Drug Fact Sheet (which describes protocol specific drug information including storage conditions and preparation guidelines)
Transfer log
Worksheet(s)

B.3 Destination Site Responsibilities: PI must make sure that site understands the responsibilities identified below.

Site pharmacy must review temperature record (if any) upon shipment receipt and inform NIH pharmacy if there are any excursions.
Ancillary supplies required for dose preparation (e.g. needles, diluent bags etc.) will not be provided. Site pharmacies are expected to use their own stock. Exception: If there are special, not readily available, ancillary supplies associated with the protocol (e.g. special syringes), NIH pharmacy will ship them with the drug.
Transfer log: the recipient must sign the transfer log to acknowledge receipt of drug and send it back to NIH pharmacy.
Worksheet (if any): must be completed during dose preparation and sent back to NIH pharmacy.
The site pharmacy must keep its own drug accountability log and be able to provide the log to NIH pharmacy.
Temperature monitoring log during storage: If the drug needs to be stored overnight before dispensing to the patient, site pharmacy must maintain temperature monitoring logs. The drugs must be stored according to their storage condition. If there are any temperature deviations during storage of drug at the destination site, it is the site’s responsibility to quarantine the product and notify the PI immediately. The site pharmacy must provide temperature monitoring log to NIH pharmacy.
All communications to NIH pharmacy must be sent to the following address: CC-PHARIDCU@mail.nih.gov

C. International Shipment

International shipping of drugs under an lnvestigational New Drug (IND) Application or drugs labelled as “for investigational use only” is subject to the US export laws, import laws of the country being shipped to, and regulatory requirements of the country being shipped to, e.g., those of the country's ministry of health and local ethics laws. IND products can only be exported internationally under specific conditions. Please refer to the attached guidance from the Office of Research Support and Compliance (ORSC). Please contact Lisa Goldfeder (Lisa.Goldfeder@nih.gov) with questions.

In addition to the above, international shipments containing materials of biological origin, including vaccines and viral vectors, must first be reviewed by the team of NIH Quarantine Permit Service Office (QPSO), a part of the Office of Research Services, Division of Occupational Health and Safety. QPSO will review applicable quarantine or trade controls and may request certification statements, letters, licenses and/or permits. QPSO qpso@mail.nih.gov should be contacted first because some clearance documents may have a lengthy review timeline (days, weeks).

After completing all requirements that apply to your situation, please fill out the following forms:

The NIH Freight Forwarding Service (FFS) (TMB_FFS_Shipping@mail.nih.gov, 301-496-5291) shall be contacted for questions regarding how to fill out the forms and the courier service who may be able to provide country specific requirements for shipment.

For form 1884, please also note below for additional guidance for some blocks:

Block 9: Leave blank. Information will be filled in/provided by NIH Freight Forwarding Service (FFS) after submission
Block 10: Fill out a complete description of the investigational drug and package contents; include the statement “Lacks Biological Material” if not biological
Block 11: Indicate hazard or infectious status; check with QPSO qpso@mail.nih.gov for biological materials
Block 12: Quantity of shipment
Block 13: Dollar value – put a value of $10.00 (just for the price of packing material. Do not enter $0)
Block 15: Put “Packed by Requester”: For room temperature drugs
Put “Packed by Shipper”: For drugs requiring temperature monitoring during shipment (e.g. refrigerated or frozen drugs)
Block 16: Put storage condition (Room temperature, Refrigerated, frozen)
Block 17: Destination address (either patient’s physician location or non-study site address)
Block 18:
- For self-administered investigational drugs (e.g. oral drugs):
  - Outpatient Pharmacy National Institutes of Health 9000 Rockville Pike, Bethesda MD 20892. Note “all” special requirements (if there is space) or block 10. For products other than room temperature, note that “A validated shipper with temperature monitoring is required. Temperature data should be provided to the requester from the courier upon arrival.”
- For investigational drugs that are administered in a healthcare setting:
  - Investigational Drug Control Unit, National Institutes of Health 1C230, 9000 Rockville Pike, Bethesda MD 20892. Note “all” special requirements (if there is space) or block 10. For products other than room temperature, note that “A validated shipper with temperature monitoring is required. Temperature data should be provided to the requester from the courier upon arrival.”

Once pharmacy receives the forms, pharmacy will send them to the NIH Freight Forwarding Service (FFS) (TMB_FFS_Shipping@mail.nih.gov) in Building 13, who will assign a courier. Once the shipping department/courier review process is complete, they will contact pharmacy and the courier will come and pick up from pharmacy to ship out.

For drugs that are administered by patients (e.g. oral drugs) for international shipments, bring the forms to outpatient pharmacy (301-435-7208) at least 7 days if possible prior to shipment. Please note that the shipment process time will depend on the FFS review and approval. Continue to order through CRIS. Questions should be directed to Nadia A. Guirguis BS, RPH, Section Chief of Outpatient Pharmacy (nguirguis@cc.nih.gov, 240-858-9436).

For drugs with a planned deviation which are described under Section B, IDCU will send the shipment to the non-study site. Please follow the directions under Section B along with completing the shipment forms.

If you have any further questions, please contact:

The Lead IDCU pharmacist of your protocol and/or

Jihyun Esther Jeon, PharmD, MBA, BCPS

Investigational Drug Control Unit Manager

NIH/CC/Pharmacy/IDMRS

10 Center Dr, Room# 1C230

Bethesda, MD 20892

Phone: 301-496-1031

Fax: 301-402-3268

Email: jihyunesther.jeon@nih.gov, CC-PHARIDCU@mail.nih.gov

Please note that this is our current thinking. As the situation evolves, we may have other information.