Contents

454 - SAMPLE SHIPMENT

When you cannot personally deliver a sample to the examining laboratory, ship it by the most economical means commensurate with the need for rapid handling. See IOM 454.02 & 454.06 for special information on shipments to FDA Headquarters' laboratories.

FDA collects a wide variety of samples, many of which are unstable, toxic or hazardous material, e.g., etiological agents, radiation products, chemical, hard swells, etc. Use safety precautions in handling and shipping commensurate with the hazard. See IOM 454.08.

454.01 - Sample Package Identification

1. Form FDA 525 - Place the FDA 525, sample package identification, near the official seal. For small containers or surfaces that will not accommodate the FDA 525, you can tie it to the sample package by using twine through the eyelet. Do not affix the FDA 525 on the outside of the shipping carton or under the official seal. Enclose a copy of the assignment document in the FDA 525 envelope and provide the following information on the FDA 525:
   1. District or Headquarters' laboratory to which the sample is directed, City, State, and unit symbol (e.g., SRL, HFD-400, HFS-300, etc.).
   2. Date.
   3. Your district and symbol.
   4. Sample Number.
   5. Name and address of the firm most likely responsible for any suspected violation.
   6. Product Identification.
   7. Address of dealer firm.
   8. Enter the reason for collection. (Copy from C/R.) Provide reference to any sampling assignment.
   9. Provide information as to the analysis to be made.
   10. Enter any pertinent remarks. Note if your district desires the return of any freezer chests, ice packs, or maximum/minimum thermometers used.
   11. Provide any special storage instructions. Mark appropriate block and enter suggested refrigeration temperature if necessary. Elaborate in Remarks if necessary.
   12. Print your name.
       See IOM 452.04 and the reverse side of the FDA 525 when using the FDA 525 as a sample package. See IOM 454.03f for information to include with the FDA 525 for medical device samples.
2. Outer Wrapper - Always place the words, "SAMPLE NO. ________" followed by the actual FACTS or OASIS sample number(s)(with appropriate prefix) on the outside of the package near the address label. This alerts the receiving mail room that the package contains a sample and must go to the sample custodian.

454.02 - Routing of Samples

In general, samples will be submitted to your district's designated servicing laboratory, except as directed by the Compliance Program Guidance Manual, assignment or your supervisor. The following provides general guidance for sample submission.

1. Vitamin & Nutritional Labeling - Submit to FDA, Science Branch (HFR-SE680), 60 Eighth St. N.E., Atlanta, GA 30309.
2. Radiopharmaceuticals for Sterility - Submit samples to WEAC.
3. Tissue Residues - Submit to the Denver District Tissue Residue Lab.

A complete, current listing of designated servicing laboratories can be found in the current ORA Field Workplan as Appendix III. This appendix is comprised of a table designating the servicing laboratories for each collecting district and for each compliance program or subpart.

454.03 - Samples to Administration Laboratories

When shipping samples to headquarters or other special laboratories use the following procedures:

1. Samples for National Center for Drug Analysis, Center for Microbiological Investigations, or Headquarters' Division analysis alone.
   1. Do not forward original C/R and records.
   2. Enclose a copy of the assignment memorandum in the FDA 525 envelope.
   3. Affix the FDA 525 to the officially sealed sample package.
   4. Submit the Original C/R and records to the home district, or forward to the home district if other than the collecting district.
2. Split Samples - Where the sample examination is split between a Headquarter's Division, the National Center for Drug Analysis, and a district lab:
   1. Follow the above procedures on the portion sent to a Headquarter's laboratory or NCDA.
   2. Submit Original C/R and records to the servicing laboratory, whether or not the home district.
3. Center for Food Safety and Applied Nutrition (CFSAN).
   Note: Unless specifically directed by a Compliance Program or an assignment, do not submit samples to the CFSAN without approval of the Office of Compliance, Division of Field Programs, Compliance Programs Branch, HFS-636 at (301) 436-2061. Send samples to CFSAN at the following address:
   
   Food and Drug Administration
   5100 Paint Branch Parkway
   College Park, Maryland 20740
   CFSAN Laboratories are as follows:
   
   1. Office of Cosmetics and Colors
      1. Division of Science and Applied Technology
         (HFS-125)
         3650 Concorde Parkway, Suite 200
         Chantilly, VA 20151
         Note: Temporary location until College Park, MD laboratories are completed. This laboratory conducts chemical and/or toxicological analyses of all cosmetic complaint samples needed for medical evaluation.
      2. Division of Programs and Enforcement Policy (HFS-105) - Conducts color analysis of foods/drugs/cosmetics.
   2. Office of Nutritional Products, Labeling, and Dietary Supplements
      Division of Research and Applied Technology (HFS-840) - Conducts examinations related to food standards and food technology. Analyzes conventional foods for requirements of nutritional properties where special skills and expertise are not available in the field.
   3. Office of Applied Research and Safety Assessment
      Division of Molecular Biology (HFS-0 25 ) - Analyses foods when the chemical methodology is under development or unusual equipment or skills are required, such as radioactivity analysis/migration of food additives from blood packaging materials. Microbiologically examines samples for potential food pathogens by rapid molecular biological testing using DNA probes, PCR and DNA fingerprint analysis.
   4. Office of Plant and Dairy Foods and Beverages
      1. Division of Natural Products, Microanalytical Branch (HFS-315) - Examines foods for bacterial contamination if field laboratory facilities are not available.
      2. Division of Natural Products (HFS-345) - Analyzes foods for non-nutritive components, including toxins.
      3. Division of Pesticides and Industrial Chemicals -(HFS-335) - Conducts examinations related to industrial chemicals contamination, including pesticides, toxic elements and radionuclides.
      4. Division of Microbiological Studies (HFS-515) - Conducts examinations related to Food Standards and food technology investigations, including the intended effect of food additives and the integrity of packaging.
   5. Office of Seafood
      Division of Science and Applied Technology (HFS-425) - Conducts decomposition, toxicity and parasite analysis of seafood where special skills or equipment required for analysis are not available in the field.
   6. Office of Food Additive Safety
      Division of Chemistry Research and Environmental Review (HFS-245) - Analyses foods and food packaging materials for direct and indirect food additives where special skills and expertise are not available in the field.
4. Center for Drug Evaluation and Research
1. Division of Pharmaceutical Analysis (DPA)
1. Testing and Research, Division of Pharmaceutical
   Analysis (DPA) (HFD-920)
   Food & Drug Administration
   Sample Room 3329
   8301 Muirkirk Road
   Laurel, MD 20708
   Conducts drug bioassay potency testing. Send samples only on request, or with prior approval. HFD-920 analyzes all heparin and insulin samples and all drugs and devices requiring toxicological analysis and evaluations of related injuries. Note: When shipping refrigerated, frozen, or perishable items, requiring prompt attention, notify the sample room, at (301) 594-5870 (or 5866) per IOM 454.05. Antimicrobial Drugs Branch (HFD-473)
   Division of Pharmaceutical Analysis (DPA)
   Food & Drug Administration
   Sample Room 3329
   8301 Muirkirk Road
   Laurel, MD 20708
   Conducts testing of all antibiotic products for composition, toxicity, etc. Note: When shipping refrigerated, frozen, or perishable items, requiring prompt attention, notify the FDA Washington, DC, sample room, at (202) 205-4034 per IOM 454.05.
2. Center for Drug Analysis (HFH-300)
   Division of Pharmaceutical Analysis (DPA)
   US Courthouse & Customhouse Bldg.
   1114 Market Street, Room 1002
   St. Louis, Missouri 63101
   Examines surveillance drug samples collected and shipped under current program directives.
5. Center for Biologics Evaluation and Research
   

   Sample Custodian (ATTN: HFM-672)
   Building NLRC
   Room 113
   Kensington, MD 20895

   Examines and reviews biological products not covered by a Compliance Program. Prior to shipping a sample, the district should notify either the Sample Custodian, (301) 594-6517, or the Surveillance and Policy Branch, (301) 594-1070, who in turn will notify the Sample Custodian.

6. Center for Devices and Radiological Health (CDRH)
   WEAC (see 1. below) is the primary laboratory for devices and radiation-emitting products. The CDRH OST laboratory accepts medical devices and radiation-emitting products for testing, but only after assignment or approval from CDRH, Office of Compliance. Note: Include in the FDA 525 envelope a copy of the manufacturers finished device specifications test methods and acceptance/rejection criteria.
   
7. 1. Send samples for sterility analysis to:
      Winchester Engineer and Analytical Center (WEAC)
      109 Holton Street (HFR-NE400)
      Winchester, MA 01890-1197
      Director, Martin J. Finkelson
      Telephone: (781) 729-5700 ext. 749 or 721
      FAX: (781) 729-3593
   2. Send bioburden analysis samples to WEAC. Send bioindicator analysis samples to WEAC.
   3. Send device and GWQAP device samples for physical and engineering analysis to WEAC.
   4. Send in-vitro diagnostic device samples to WEAC.
   5. Send devices used for antibiotic susceptibility testing (including discs) requiring performance testing to WEAC.
   6. Send Southwest and Pacific Region condom and glove samples to the Pacific Regional Laboratory (PRS)
   7. Send all other condom and glove samples to WEAC.
   8. Send radiological health samples to :
      CDRH/OST Sample Custodian HFZ-105
      12725 Twinbrook Parkway, Room 210
      Rockville, MD 20852
      Telephone: (301) 827-4723
      FAX: (301) 827-4731
   Note: Contact Electronic Products Branch, HFZ-342, (301) 594-4654 prior to collection and shipment of any radiological product sample.
8. Center for Veterinary Medicine
   Division of Compliance (HFV-230)
   7500 Standish Place (MPN II)
   Rockville, MD 20855
   (301) 827-1168
   Samples of veterinary products, not specifically covered by one or more of the CVM Compliance Programs, can be sent to the above address for review, evaluation, and comment. This includes documentary samples, and labels/ labeling and advertising materials. There are no laboratory facilities at MPN II. If you have questions about sampling or sample destinations, contact HFV-230 and/or the applicable program contact.

454.04 - Sample Shipment to Outside Agencies

Do not ship any samples outside FDA unless your assignment, applicable program, or your supervisor specifically instructs you to do so.

454.05 - Notifying Receiving Laboratories

When frozen, perishable, or high priority items are shipped, notify the receiving district or lab by telephone, or e-mail, that you have shipped the sample. Provide the following information:

1. Sample Number
2. Name of Product
3. Number of Parcels in Shipment
4. Carrier's Name
5. Carrier's Waybill Number
6. Carrier's Train, Truck, Bus, or Flight Number
7. Estimated Time and Date of Arrival
8. Relevant Remarks, i.e., "Sufficient Dry Ice to maintain frozen until 8:00 AM, (date)"
9. Place the name and telephone number of the person that is to receive the sample on the outer shipping carton near the address with instructions to the carrier to contact the above named individual upon arrival of the package.

Note: When shipping refrigerated, frozen, or perishable items requiring prompt attention to the Division of Drug Biology, Antimicrobial Drugs Branch (HFD-473), notify the FDA Sample Room, at (202) 205-5284.

454.06 - Method of Shipment

Note: If samples are shipped to headquarters laboratories by bus lines, delivery of the sample must be specified on the bus bill.
Use the most economical method of shipment consistent with the need for special handling. Shipping costs may be reduced by packing samples addressed to the same consignee into a larger carton or by "piggy-backing" (taping a number of larger boxes together and shipping them as one package). Make sure the total package is within the carrier’s weight and size limits.

454.07 - Parcel Post

When samples are shipped by parcel post, do not exceed the parcel post limits as to size and weight.

1. Package Limits
   1. From a first class post office to a first class post office: Weight - 40 lbs.
      Size - 84 in. length and girth combined.
      
   2. Mailed at or addressed to a second or lower class post office:
      
      Weight - 70 lbs.
      Size - 100 in. length and girth combined.
2. Address Labels - The use of franked labels and envelopes is no longer allowed. Affix proper postage to envelope or address label after using district or resident post postal scale and meter. If no postal meter is available, use the resident post postage scale to weigh the envelope or package and add the proper postage using postage stamps. If no stamps are available purchase them from the post office and claim reimbursement on your voucher. Obtain a receipt for the stamps or postage, if required by your District Office.

If the package is addressed to an FDA unit, show the FDA routing symbol following the name of the FDA unit.

Note: Wrap parcels shipped "Registered Mail" in kraft paper because the postal service must affix an ink stamp seal to each closure point. Do not wrap the outer package with tape that has a shiny or glossy surface (e.g., masking tape, filament tape, scotch type tape, etc.).

454.08 - Common Carrier

Certain Department of Transportation (DOT) regulations exist pertaining to carrier inspection of packages. Instruct the carrier to contact the shipper (FDA) prior to any package inspection requires breaking the official seal. Carriers have broken FDA official seals for package inspection during transit, thereby compromising the sample integrity.

If an FDA 3082 - Shippers Declaration for Dangerous Goods is executed for shipments of restricted items, place a statement in the special handling section that breaking an FDA official seal is not authorized, and to contact the shipper (FDA) if there are any question regarding the shipment. See IOM Exhibit 450-B.

1. Shipment - You must decide how your samples are shipped. The judgment must be based on your knowledge of the practices and performance of the transportation firms in your area. As a general rule, Parcel Post, United Parcel Service, or current GSA contract carrier should be used for small packages and other express or comparable carriers for packages too large for PP, UPS, or current GSA contract carrier. Before using motor express lines and passenger bus lines determine that their schedules and delivery practices are satisfactory and reliable. Bus lines must not be used for shipments to Washington, DC offices unless delivery at the destination address is specified.
   
   Air express or air freight shall be used only for samples requiring extremely rapid handling or where more economical means of shipment are not available or feasible.
   Air freight service is offered by the individual air lines and, although usually not as convenient as express, is more economical and should be used especially for shipments of 50 lbs. or more.
2. Designated Carriers - You may ship by any carrier you wish with the objective of obtaining the best possible service at the most economical rate.
   
   Always indicate on the carrier's shipping document that the shipment is a U.S. Government shipment.
3. Government Bill of Lading - Prepare Form SF-1103, Government Bill of Lading (GBL), for shipments made by common carrier except as described below. Distribute GBL as follows:
   Give the Carrier:
   
   Original (White) Form SF-1103
   Shipping Order (Pink) Form SF-1104
   Freight Waybill Original (White) Form SF-1105
   Freight Waybill Carriers Copy (White) Form SF-1106
   
   Submit the remaining 4 copies "Memoranda Copy" (Yellow), Form SF-1103a, and the "Memorandum Copy" (Blue), Form SF-1103b, to your district.
   If available, obtain the transportation costs or the rate from the carrier and enter it in pencil on the copies submitted to the district.
4. Commercial Bill of Lading - The use of commercial forms (in lieu of GBL's) and procedures for small shipments is subject to the limitations and instructions set forth in the following paragraphs. The use of commercial forms shall be limited to those carriers that have a letter of agreement with FDA or GSA.
   The use of commercial forms is to be applied only to the following types of shipments:
   
   1. Shipments for which the transportation charges ordinarily do not exceed $100.00 per shipment and the occasional exception does not exceed that monetary limitation by an unreasonable amount.
   2. Single-parcel shipments via express, courier, small package, or similar carriers, without regard to shipping cost, if the parcel shipped weighs 70 lbs. or less and does not exceed 108 inches in length and girth combined.
   3. Multi-parcel shipments via express, courier, small package or similar carriers for which transportation charges do not exceed $250.00 per shipment.
5. Address Labels - Affix a completed address label, form HHS-409, U.S. Government shipment to each shipping carton. Use the street address of the consignee, do not use the post office box numbers, since carriers usually will not deliver to PO box numbers. If the package is going to an FDA unit, include the FDA routing symbol in the consignee address. If shipment is made under the GSA-Carrier Agreement, strike out the information on GBLS in the lower left corner of the form since a GBL is not used.
6. Shipment of Hazardous or Toxic Items - The Department of Transportation (DOT) regulations require certain packaging, forms, certifications, declarations, and/or statements covering shipment of hazardous or toxic items. Except for dry ice, most of the samples of hazardous or toxic materials we ship are classified as "ORM-D, Consumer commodity". Both dry ice classified as "9", and ORM-D classifications require a certification/declaration for shipment by air but not for shipment by surface transportation.
   
   Shipments containing dry ice - use the dedicated Dry Ice Sticker (available from the carrier - for an example see IOM Exhibit 450-C). Complete the bottom portion of the sticker and note the amount of dry ice in kilograms. In addition to the label, the package itself must be clearly marked in 1" block letters: "DRY ICE; 9; UN1845".
   
   Contact the carrier involved to execute the necessary forms, certification/declarations, packaging, marking, etc. required for the particular shipment or hazardous or toxic items.
7. Always pack liquid products in sufficient cushioning and absorbent material to absorb any breakage which might occur. Check with the Post Office or other carriers regarding shipment of liquids.
8. Hard swells may explode. Wrap them heavily in paper and cushioning material for shipment and submit promptly.
9. Observe special precautions when shipping products in pressurized containers to avoid exposure to excessive heat. Air shippers who ship in non-pressurized planes may also have special requirements for this type container. Check Post Office and carrier for regulations, precautions, or restrictions before shipping products in this type container.
10. Special precautions for both packaging and shipping radioactive substances must be observed. If necessary, consult your supervisor, the regional radiological health representative, WEAC or the applicable program.

Note: The compliance program for radioactive drugs directs the manufacturer to ship samples via their normal mode of transportation to WEAC. The Nuclear Regulatory Commission (NRC) requires that firms manufacturing radioactive drugs ship only to NRC licensed consignees. WEAC's NRC license number is 20-08361-01 Exp. Date 2-28-2006. This license number should be used for any shipments of radioactive products to WEAC.

454.09 - Certified and First Class Mail

Where speed is essential and a record of receipt of the sample is desired, small samples may be sent by express mail or certified air mail, or, in situations where speed is a factor but the receipt is not necessary, by first class air mail. Where other methods of shipment do not suffice, larger samples may be shipped certified or first class as a last resort. Normally do not use certified or first class for routine samples.

455 - PAYMENT OF SHIPPING CHARGES

1. Cash Payment - Agencies have authority to use imprest funds (pay cash) for Cash On Delivery (COD) payment of transportation charges. See IOM 454.8a and IOM 454.08d.
   
   1. Shipments between districts may be shipped COD when the conditions cited above are met.
   2. Shipments to headquarters may be shipped COD but you must enter on the firm's commercial bill of lading that the FDA billing unit is as follows:
      
      Food and Drug Administration
      Accounting Branch (HFA-120)
      5600 Fishers Lane
      Rockville, MD 20857
2. Other Means of Payment - If you do not pay cash or the shipping cost exceeds those circumstances in IOM 454.8d, you must use one of the following payment methods:
   
   1. Postal meter or postage stamps - You can use these for shipments under 70 lbs/ when it is cost effective.
   2. Billed shipments - Those shipments meeting the criteria in IOM 454.8a and IOM 454.08d and are billed by an invoice from the carrier.
   3. Government Bill of Lading (GBL) - If the other methods discussed above are not appropriate, a GBL must be issued at the time of the shipment.
   4. In an emergency, if you are without a GBL or the carrier refuses to accept a GBL at the time of shipment, you can convert the carrier's invoice to a GBL after the completion of the shipment. Avoid this procedure if at all possible.