Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 4.5 - SAMPLING: PREPARATION, HANDLING, SHIPPING

Table of contents

4.5.1 - OBJECTIVE

The preparation, handling, and shipping of samples is your responsibility, and must be carried out in a manner which assures the sample's integrity and supports testimony that the sample examined was the same sample you collected from the documented shipment.

As few persons as possible should handle the sample to reduce the likelihood of compromising sample integrity. See ORA Lab Manual, Volume II, Section 5.8 for information about relinquishing samples.

  4.5.2 - IDENTIFYING MARKS

  4.5.2.1 - Subsamples

Identify a representative number of subsamples (subs) with the sample number (including prefix, if appropriate), collection date and your handwritten initials. If individual sub identity must be maintained, assign and mark each sub with a separate Arabic numeral. In some comprehensive inspections or investigations it may be important to correlate the manufacturing control code with the sub number.

When a variety of articles are included under one sample number, fully identify each sub and describe them on the C/R. Factory exhibits should be fully identified and, where appropriate, correlated with inspectional observations, manufacturing procedures, and/or routes of contamination. See IOM 4.2.5.6 for using the FDA 484 - Receipt for Samples as a memo to accompany C/R to describe subs collected.

When multiple subs are taken from cases, bales, boxes, etc. in the lot, Arabic numerals and letters in combination may be used for identification. For example: if two cans are taken from each case in the lot, the cans may be marked as subs 1a, 1b, 2a, 2b, etc. to identify the subs as coming from case #1, case #2, etc. If the second can or container taken from each case is the 702(b) [21 U.S.C. 372(b)] portion, it is desirable that all duplicate portions be sealed separately from the FDA portion. This fact should be so noted on the cases and C/R.

If multiple subsamples are to be collected, it may be advantageous to place identifying information such as sub number, sample number, and collection date on peel-off labels, tape, etc. in advance of sampling to save valuable time. Your initials must be in your own handwriting.

  4.5.2.2 - Borrowed Samples

Although most samples are purchased, some may be borrowed, non-destructively examined, and returned to the owner. These samples must be handled carefully to avoid defacing or damaging the product.

Identify borrowed samples so the identification can be removed with no damage to the product, i.e. a sticker label that can be peeled off.

  4.5.2.3 - Identification Techniques

Mark a representative number of subsamples with the sample number, collection date and your hand written initials. Similarly identify any outer packaging, labels or circulars. If more than one person is involved in collecting the sample, the person preparing and signing the C/R initials the subs. Reinsert circulars removed from packages. See IOM 4.3.2.2 for procedures on identifying lots from which sampled.

Transparent tape such as Scotch Magic Transparent tape accepts ball point ink and may be used on glossy items such as glass, plastic, tin, etc. Glass, such as bottles, vials and ampoules, may be identified by using a very fine pointed felt or nylon marking pen and covering the identification with transparent tape for protection.

Do not use tape on very small containers such as ampoules, which must be snapped or broken to remove the contents for analysis. Tape wrapped around the container may interfere with assay.

Do not use permanent type markers when identifying subs in absorbent containers if the ink may penetrate into the product thus contaminating the sample.

Diamond or carbide tipped stylus pencils may be used to mark tin, glass, etc. Do not use diamond or carbide tipped stylus to mark products in glass under pressure (i.e., carbonated beverages).

  4.5.2.4 - Photographs

Unless they are part of a DOC Sample, photographs are exhibits, to an EIR, report of investigation, or complaint. They are not samples. Photos taken during inspections and investigations are not described on a C/R, but are submitted as exhibits with the EIR. Photographs related to DOC Samples, i.e., labeling, records, product, etc. are identified with the sample number, collection date, and handwritten initials on the border or backside. See IOM 5.3.4.2. Attach the photos to the printed FACTS Collection Record. See IOM 4.4.10.5.

In describing photographs, do not mark the face of the print. Narrative descriptions may be placed on the mount-ing paper next to the print or, if explanatory graphics are required, use a plastic overlay. See IOM 5.3.4.2.3 for negative identification and submission procedures and IOM 5.3.4.2.5 for digital photos.

  4.5.2.5 - Records - Accompanying Literature and Exhibits

Identify all copies of sample records, accompanying literature, and attached documents with the sample number (including prefix, if applicable), collection date and your handwritten initials as described in IOM 4.5.2.1. If an attached document is more than one page in length, it must be numbered or attached in a manner that will always allow further reviewers to determine if any pages are missing.

  4.5.3 - SAMPLE HANDLING

All samples must be handled, packaged, and shipped to prevent compromising the identity or integrity of the sample. Samples must be packed with shock absorbing materials to protect against breakage of containers or damage to Official Seals. Frozen samples must remain frozen; perishable products may be frozen, if freezing doesn't interfere with the planned analysis, products requiring refrigeration (e.g., fresh crabmeat for bacteriological analysis) should be shipped in ice. Use your experience and knowledge (and that of your supervisor, if necessary) to determine the most appropriate packing and shipping method.

  4.5.3.1 - Fumigation

See IOM 1.5.3.1 for safety precautions.

General - As soon as possible, freeze any sample containing, or suspected to contain live insects, as long as freezing will not change or damage the product or break the container. If freezing is inappropriate to maintaining the integrity of the sample, fumigation may be carried out using air tight containers (such as a mason-type jar with inner ring, or a polypropylene container with air tight lid), with sufficient fumigant to kill the insect infestation. Contact your servicing laboratory for alternative fumigants.

Moth crystals, containing paradichlorobenzene (PDB), is an alternative fumigant. Do not use mothballs or moth flakes containing naphtha or naphthalene. Do not use moth crystals in or near plastics, particularly Styrofoam/ polystyrenes as crazing or melting may occur. Other alternative fumigants include: liquid household ammonia or ethyl acetate, either of which can be used to dampen a cotton ball and placed in an appropriate container; or cut small portions of commercial pesticide strips.

  4.5.3.1.1 - FUMIGATION SAFETY PRECAUTIONS

Follow safety precautions when fumigating samples. Contact your local servicing laboratory or MSDS for the appropriate protective gear and handling of fumigants. Guidance is as follows:

  1. Carry all alcohols, fumigants, and other hazardous liquids in approved safety containers.
  2. When fumigants or preservatives are used, limit your exposure to these chemicals. Minimize transfer and exposure time. Avoid getting chemicals on hands or clothing. DO NOT MIX CHEMICALS.
  3. Insure DOT regulations and guidance and International Air Transport Association (IATA) guidelines are followed when mailing or shipping samples containing fumigant or preservative. Exceptions for small quantities are listed in 49 CFR 173.4.
  4. The sample identification data on your packaging, the FDA-525 and C/R, must always identify the fumigant and method of fumigation, and/or preservative used.
  5. Material Safety Data Sheets (MSDS) for each chemical fumigant or preservative used must be available at each duty site and enclosed with the shipped sample. Read and follow all instructions and precautions listed on the MSDS.

  4.5.3.1.2 - Procedures For Fumigation

Place a small amount of fumigant, in an airtight container. Separate the fumigant from the sample with a piece of paper, paper napkin, or unscented facial tissue. Put specimen or product into container and seal tightly. Do not re-open container unless absolutely necessary. If possible, use a glass container with a lined screw lid. A mason-type jar with inner ring is also acceptable.

  4.5.3.1.3 - Exceptions To Fumigation

When submitting samples or exhibits to show live infestation, do not fumigate. Consult with your supervisor or your servicing laboratory PRIOR to sending or bringing a live infestation into the laboratory to permit preparation for proper handling and storage. Do not fumigate sample when submitting samples for pesticide residue analysis.

  4.5.3.1.4 - Preservation Liquids

Insects may be killed and preserved in 70% ethyl alcohol or a 1:1 mixture of 70% ethyl alcohol and glycerin (may be labeled glycerol). These chemicals can be obtained from your servicing laboratory. Do not collect rodents or animal tissues unless specifically instructed. Insure all vials or bottles of preservation liquids are tightly sealed to avoid leakage. Identification labels may be placed in containers, but must be written in India ink or 2H pencil only. Keep all preservation liquids away from excessive heat or open flame.

Identify preservative used on FDA 525, C/R, and on sample container. Enclose a copy of the MSDS with the shipped sample. Follow DOT and IATA guidelines when shipping or mailing samples with preservatives as stated under fumigants.

  4.5.3.2 - Labeling

Samples collected for label review only should be officially sealed in clear plastic bags. This will permit cursory review and, if necessary, photocopying of the container label and reduce the need to break the seal each time the label is examined.

  4.5.3.3 - Samples for Pathological Examination

Tissue samples are not routinely collected for microscopic or pathological examination. Authorization must be obtained from the appropriate Center before collecting samples of this material.

When assigned to collect tissue samples, unless directed otherwise by the program, the assignment, or your supervisor, cut the tissue into 1/4 inch pieces and preserve in 10% buffered formalin, or in other suitable preservatives as directed. Do not freeze the sample since frozen tissue is not suitable for pathological studies.

  4.5.3.4 - Small Sample Items

Samples in small vials, bottles, boxes and similar type containers may be placed inside the FDA 525 envelope after identification. When the envelope is used as the sample package, place the official seal across the glued flap and the blank face of the form.

If the sample container (vial, bottle, etc.) is officially sealed, it may be placed in the same FDA 525 together with copies of the assignment.

  4.5.3.5 - Frozen Samples

Containers - Pre-chill sterile containers before collecting frozen samples. Transfer liquids in glass to expandable containers before freezing. If the liquid must be frozen in glass, leave sufficient headspace to allow expansion. If freezer facilities are not available or if the sample is to be shipped, pack with dry ice in insulated cartons.

Dry ice and insulated cartons may be obtained from ice cream or dry ice dealers, and economical polystyrene (Styrofoam) containers are available at most variety stores. However, while Styrofoam containers have excellent insulating qualities, they will not withstand shipping abuse unless protected by sturdy outer cartons.

Note: If your district desires the return of Styrofoam freezer chests or ice packs used in shipping samples, note this fact on the C/R and FDA 525.

Dry Ice - Caution: Dry ice is potentially dangerous and requires caution in handling and shipping. Do not handle with unprotected hands; transport in your car without adequate ventilation; or place inside tightly closed metal, glass, plastic, or similar type containers that do not breathe. If it is necessary to use this type container, adequately vent to prevent pressure build up.

Note: If a sample is to be analyzed for ammonia contamination, it must not be shipped frozen in dry ice. Use other methods of freezing, if frozen shipment is necessary.

  4.5.3.5.1 - Shipping Frozen Samples

If using a U.S. Government Bill of Lading, it is important to give a full and accurate description of the sample for rate purposes. If more than one commodity is in the shipment, describe and enter each separately.

In all packages where dry ice is used, distribute the dry ice equally on all sides of the sample package using pieces as large as possible. Be sure the container is insulated on all six sides and tape all edges securely to assist in insulating the carton. Do not place dry ice inside officially sealed packages.

Freezing by dry ice is not effective for more than forty-eight hours. For overnight shipments, use at least one pound of dry ice per pound of sample. Increase the amount for longer hauls or unusually warm weather. (Note: When samples are in plastic type containers, the dry ice must be wrapped in paper to prevent direct contact with the plastic. The extreme cold generated by the dry ice may cause plastic to become brittle and rupture.)

Shipments made via FedEx Corporation, Priority I, Purolator, Airborne or by other fast air express carriers, will be delivered to consignees early the next business day. Tests have shown the following amounts of dry ice will be adequate when this method is used:

For samples already in frozen state: five to ten pounds of dry ice depending on sample size is normally sufficient. For samples requiring only to be refrigerated: A minimum of ten pounds of dry ice is sufficient.

Note: The dry ice may freeze the edges of the product, so if it is imperative no part of the sample becomes frozen, use coolants other than dry ice. Mark the FDA 525 that dry ice was used.

See IOM 4.5.5.8.6 when shipping sample packages containing hazardous or toxic items, including dry ice, by air.

  4.5.3.5.2 - Control

To prove the shipment did not thaw in transit, place a jar or leak proof plastic bag of chipped ice in the shipment adjacent to the sample package, but not within the officially sealed package.

  4.5.3.6 - Refrigerated (Not Frozen) Samples

Maintain refrigerated (not frozen) samples in a refrigerator at 4.4oC (40oF) or below. Use either wet ice or some type of "Ice Pak", "Liquid Ice", "Sno-Gel", "Kool-It", or similar products to maintain the required temperature range.

Place Ice Paks, etc., in sealed plastic bags to protect samples from possible contamination should the container break, the ice melt, or the refrigerant penetrate the sample. Use Styrofoam insulated shipping cartons for shipping samples to the laboratory.

  4.5.3.6.1 - Control

If it is necessary to show the sample temperature did not go above the desired or specified temperature, you can use one of several methods, such as including a pre-chilled, shaken down, maximum reading thermometer or commercially available indicators. Take care to place the thermometer outside of the sealed sample package and attempt to place in an area anticipated to be likely to reach the highest temperature. Describe the method used on your C/R.

  4.5.4 - OFFICIAL SEALS

Domestic samples, regardless of type, shall be sealed with form FDA 415a, Official Seal, or, in some situations with the FDA " Metal Seal". See IOM 4.5.4.6 for use of metal seals. See also IOM 4.1.4.2.

Note: With the approval of your supervisor and laboratory, it is not necessary to affix an official seal to a sample that will be in the sample collector's continuous personal custody until it is submitted personally to an analyst. This procedure should be reserved for emergencies and high priority situations. The sample should be submitted the same day it is collected with the subs properly identified. The C/R must state you personally delivered the sample to "Analyst ______"or other appropriate staff member.

Make every effort to prepare and submit your samples on the date collected so the C/R, sub identification, and the final official seal bear the same date, and thus enhance sample integrity. However, if you cannot finish the sample preparation on the same day collected, you must explain in the C/R Collection Remarks field what steps you took to protect the integrity of the sample, e.g., officially sealed and locked in supply cabinet, locked in safe, etc.

Never place more than one sample in the same officially sealed package.

  4.5.4.1 - Preparation

Inscribe FDA 415a, official seal, with the district office name, sample number (with the appropriate prefix), the date applied, your signature, printed name and title. See IOM Exhibit 4-17. The seal must bear only one signature. If more than one person is involved in collecting the sample, the person preparing and signing the collection record must sign the seal.

  4.5.4.2 - Application

Seal the sample package so that it cannot be opened at any point without evidence of tampering. If the surface of the sample container is of such construction or condition that the FDA-415a, official seal, will not adhere (e.g., waxed carton, frosted over, sweating, etc.), wrap or place sample in a container to which the official seal will hold. See IOM 4.5.4.6.

When using the self-adhering seals, the surface on which the seal is to be placed must be clean and dry. The seal must be rubbed when affixed to generate heat and help it bond.

  4.5.4.3 - Sealing Method

There are many acceptable methods of officially sealing samples. Because of the wide variety of shapes and sizes of samples, and the ingenuity you may have to apply to package and packaging situations, explicit methodology will not be detailed here. Your supervisor, your on-the-job training, and your developing experience will familiarize you with the most effective methods.

  4.5.4.4 - Protecting the Official Seal

Protect the sealed surface by wrapping the package securely with heavy wrapping paper for mailing or shipment. If your officially sealed package is not further wrapped for shipping and the tape(s) and official seal are thus exposed, you must protect the Official Seal from damage during shipment by:

  1. Covering the official seal with a sheet of heavy wrapping paper or heavy clear plastic (e.g. from a document protector) of sufficient size to cover the surface of the official seal.
  2. Tape the protective paper or heavy clear plastic securely around the edges so it cannot come loose and expose the official seal. Do not paste or glue the paper or plastic to the face of the official seal since this will obliterate the official seal when removed.
  3. When you protect the official seal by heavy paper, write "FDA Seal Underneath", or similar wording across the protective paper. This alerts the receiving custodian the official seal is underneath, and to take care when removing the protective paper. If you cover and protect the seal with heavy clear plastic, the sample custodian will be able to copy the necessary information off the seal without removing the protective cover.

  4.5.4.5 - Broken Official Seals and "Temporary Seals"

Reseal the sample whenever you break the official seal. Each seal used on the sample will be submitted with the records associated with the collection record, properly initialed and dated, to provide a continuous history.

There is only one class of seal: an "official seal". Anytime a sample is sealed with the FDA 415a, or with the FDA Metal Seal, the item is "officially sealed". An officially sealed sample must sometimes be reopened to prepare it for submission to the laboratory, or for some other legitimate reason. In that situation, the original seal must show the date it was broken. When the sample is ready to be resealed the new seal must show the date it is applied. This procedure must be followed each time the official seal on a sample is broken. Each seal will show the history of the date it was applied and broken. See instructions in Exhibit 4-17. Indicate in the collection remarks field of the FACTS C/R the fact that the seal was broken and reapplied and attach the broken seal to the printed FACTS C/R. This provides an unbroken, documented chain of custody.

  4.5.4.6 - Metal SealsHighlighted to denote updated text

Where it is impossible to use the paper official seal, the numbered self-locking "U.S. Food and Drug" metal seal may be used. This seal is effective for use on wooden crates, drums, baskets, etc., where the FDA 415a cannot be used. Record the number of the metal seal used on the CR. See IOM 4.3.4.3 for instructions on the use of the metal seal to reseal railroad cars or conveyances. When a supply of these seals are needed by your district, contact the Division of Food and Feed Operations and Inspections at (301) 796-0360Highlighted to denote updated text.

  4.5.4.7 - Sealing Non-Sample Items

Although the primary purpose of the official seal is for sealing samples, there are times when the official seal may be used to officially seal items other than samples. The FDA metal seal is often used to seal rail cars or vehicles as indicated in IOM 4.3.4.3.

When directed by your supervisor, you may use an official seal to seal questionable or suspicious bioresearch records encountered during an inspection or investigation to prevent tampering or to preserve their integrity. As explained in the applicable compliance program, the procedure must have the approval of the bioresearch monitoring staff (HFC-230) prior to implementation.

  4.5.5 - 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 4.5.5.2 and 4.5.5.6 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 4.5.5.8.7.

  4.5.5.1 - Sample Package Identification and FDA 525

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 of dealer.
  6. Product Identification.
  7. Address of dealer.
  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 4.5.3.4 when using the FDA 525 as a sample package. See IOM 4.5.5.3.6 for information to include with the FDA 525 for medical device samples.

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.

  4.5.5.2 - Routing of SamplesHighlighted to denote updated text

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

  1. Vitamin and 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.

  4.5.5.3 - Samples to Administration Laboratories

When shipping samples to headquarters or other special laboratories follow the procedures for each laboratory.

  4.5.5.3.1 - Split Samples

Where the sample examination is split between a Headquarters Division, the National Center for Drug Analysis, and a district lab:

  1. Follow the above procedures on the portion sent to a Headquarters’ laboratory or NCDA.
  2. Submit Original C/R and records to the servicing laboratory, whether or not the home district.

4.5.5.3.2 - National Center For Drug Analysis Or Headquarters' Division

National Center for Drug Analysis 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.

  4.5.5.3.3 - Center For Food Safety And Applied Nutrition (CFSAN)

Submit samples to CFSAN as directed by a Compliance Program, Field Assignment or with approval of the Office of Compliance, Division of Field Programs and Guidance,Compliance Programs Branch (HFS-615) . The Compliance Program, Field Assignment, or approval will provide sample information and instructions for shipping to the appropriate CFSAN laboratory. CFSAN laboratory locations are:

Food and Drug Administration 5100 Paint Branch Parkway College Park, Maryland 20740

FDA Gulf Coast Seafood LaboratoryHighlighted to denote updated text Iberville Drive Dauphin Island, AL 36528

    Office of Regulatory ScienceHighlighted to denote updated text
    1. Division of Bioanalytical Chemistry (HFS-715) - Conducts laboratory investigations in the broad areas of elemental analysis, natural toxins, nutrients in food, ingredients in dietary supplements, and ingredients of cosmetics.
    2. Division of Analytical Chemistry (HFS-705) - Conducts laboratory investigations in the broad areas of food additives, allergens, pesticides, dietary supplements, seafood toxins, food defense threat agents, and industrial chemicals that may contaminate CFSAN regulated products.
    3. Division of Microbiology (HFS-710) - Develops, optimizes, and validates methods for recovery, detection, identification, and quantitation of pathogens and toxins from foods and cosmetics, and the processing environment. Maintains FDA's food-related gateway to the PulseNet System. Develops and applies subtyping methods to further enhance data generated for Pulsenet, strain identification, and molecular epidemiological investigations.
    Office of Applied Research and Safety AssessmentHighlighted to denote updated text
    1. Division of Molecular Biology (HFS-025) - Analyzes foods when the chemical methodology is under development or unusual equipment or skills are required, such as radioactivity analysis and migration of food additives from food packaging materials. Microbiologically examines samples for potential food pathogens by rapid molecular biological testing using DNA probes, PCR, and DNA fingerprint analysis.
    Office of Cosmetics and ColorsHighlighted to denote updated text
    1. Division of Color Certification and Technology (HFS-105) - Conducts analyses of color additive samples submitted to FDA for certification, assigns certification lot numbers to compliant lots, and denies certification to non-compliant lots. Develops, optimizes, and validates methods for the determination of components and impurities in certifiable color additives. Develops, optimizes, and validates methods for the determination of color additives in foods and cosmetics. Conducts analyses of foods and cosmetics for color additive content when special skills and expertise are not available in the field.
    Office of Food SafetyHighlighted to denote updated text
    1. Division of Seafood Science and Technology, Gulf Coast Seafood Laboratory (HFS-400) - Conducts microbiological and chemical investigation of seafood, including bacterial and viral pathogen, natural marine toxins, aquaculture drugs, products of decomposition, and other contaminants when special skills or equipment required for analysis are not available in the field.

 4.5.5.3.4 - Center For Drug Evaluation And Research Division Of Pharmaceutical Analysis (DPA)Highlighted to denote updated text

Examines surveillance drug samples collected and shipped under current program directives. Analyzes all heparin and insulin samples

CDER-OPS-OTR Division of Pharmaceutical Analysis (DPA) 645 S. Newstead, Ave. St. Louis, MO 63110Highlighted to denote updated text

  4.5.5.3.5 - Center For Biologics Evaluation And Research (CBER)Highlighted to denote updated text

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 Regulations and Policy BranchHighlighted to denote updated text, 301-827-6210, who in turn will notify the Sample Custodian.

  4.5.5.3.6 - Center For Devices And Radiological Health (CDRH)

WEAC Highlighted to denote updated text (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.

  1. Send samples for sterility analysis to: Winchester Engineering and Analytical Center (WEAC) 109 Holton Street (HFR-NE400) Winchester, MA 01890-1197 Patrick Regan, Director, Analytical Telephone: 781-756-9707 FAX: 781-756-9757
  2. Send bioburden analysis samples to WEAC.
  3. Send bioindicator analysis samples to WEAC.
  4. Send device and GWQAP device samples for physical and engineering analysis to WEAC.
  5. Send in-vitro diagnostic device samples to WEAC.
  6. Send devices used for antibiotic susceptibility testing (including discs) requiring performance testing to WEAC.
  7. Send Southwest and Pacific Region condom and glove samples to the Pacific Regional Laboratory (PRS)
  8. Send all other condom and glove samples to WEAC.
  9. Send radiological health samples to: CDRH/OSEL Sample Custodian HFZ-105 WO62, 10903 New Hampshire Ave,, Room 4126 Silver Spring, MD 20993 Telephone: 301-796-2558 FAX: 301-796-9795 Note: Contact Office of Science and Engineering Laboratories, 301-796-2558 prior to collection and shipment of any radiological product sample.

  4.5.5.3.7 - Center For Veterinary Medicine (CVM)

Center for Veterinary MedicinesHighlighted to denote updated text Division of Compliance (HFV-230) 7500 Standish Place (MPN II) Rockville, MD 20855 240-276-9200

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.

4.5.5.3.8 - Center For Tobacco Products (CTP)

Do not collect samples of tobacco products unless directed by an assignment, approved by the Center for Tobacco Products, Office of Compliance and Enforcement, or by District Management. Send compliance and surveillance samples to: Southeast Regional Laboratory (SRL). (See ORA Directory for address and phone numbers).

Send compliance and surveillance samples to: Southeast Regional Laboratory (SRL), Atlanta Center for Tobacco Analysis. Contact information on Atlanta Center for Tobacco Analysis website.Highlighted to denote updated text

  4.5.5.4 - 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.

  4.5.5.5 - 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.

  4.5.5.6 - 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.

  4.5.5.7 - 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.).

Some items cannot be mailed or can be mailed only in small quantities for safety and legal reasons. Call 1-800-ASK-USPS or visit your Post Office if you have questions.

  4.5.5.8 - 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 questions regarding the shipment. See IOM Exhibit 4-18.

  4.5.5.8.1 - 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.

  4.5.5.8.2 - 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.

  4.5.5.8.3 - 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:

  1. Original (White) Form SF-1103
  2. Shipping Order (Pink) Form SF-1104
  3. Freight Waybill Original (White) Form SF-1105
  4. 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.

  4.5.5.8.4 - 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.

  4.5.5.8.5 - Address Labels Highlighted to denote updated text

Form HHS-409, address and sample number identification label, is no longer available. Until a new standardized label is issued, investigators need to use the street address of the receiving laboratory or office. Do not use the post office box number as contract carriers may not deliver to PO Box numbers. Place the words "SAMPLE NO", followed by the appropriate sample number(s), on the outside of the shipping package(s). The package(s) should be properly identified with the FDA office shipping the sample and the receiving laboratory or other office.Highlighted to denote updated text

  4.5.5.8.6 - 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 4-19). 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.

For further information, contact your district Safety Officer or Industrial Hygienist.

  4.5.5.8.7 - PRECAUTIONS

The following precautions should be observed when shipping samples:

  1. 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.
  2. Hard swells may explode. Wrap them heavily in paper and cushioning material for shipment and submit promptly.
  3. 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.
  4. 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 06/30/2016. This license number should be used for any shipments of radioactive products to WEAC.

  4.5.5.9 - 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.

  4.5.6 - 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 4.5.5.8.1 and IOM 4.5.5.8.2.
    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 Division of Accounting(HFA-120) 1350 Piccard Dr. Rockville, MD 20850
  2. Other Means of Payment - If you do not pay cash or the shipping cost exceeds those circumstances in IOM 4.5.5.8.4, 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 4.5.5.8.1 and IOM 4.5.5.8.4 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.

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