Attachment 5 - Preservation Packaging Packing Labeling and Marking PPPLM.pdf

Preservation, Packaging, Packing, Labeling, and Marking (PPPL&M), Wood Packaging Material (WMP) and Cold Chain

Management

Hazardous material (HAZMAT) and Temperature Sensitive (Reefer/Freezer) products:

All HAZMAT will be ordered under separate call numbers. All Temperature Sensitive products will be ordered under separate call number(s). HAZMAT and Temperature Sensitive products will not be ordered under the same call number(s) issued on the customers’ regular pharmaceutical order(s).

The Primary Supplier PS and the BS will provide each customer a breakdown between the HAZMAT and Temperature Sensitive products. If a customer orders a HAZMAT or Temperature Sensitive product with their regular pharmaceutical order, the HAZMAT or Temperature Sensitive product will be killed.

17. Preservation, Packaging, Packing, Labeling, and Marking (PPPL&M)

A. For delivery to all domestic (CONUS) and overseas (OCONUS) customers.

1. General Instructions.

a. Unless otherwise specified, all PPPL&M requirements specified herein shall apply to all CONUS and OCONUS shipments of medical items.

b. Labeling and shipping instructions specified in para. 17.B. shall also apply to OCONUS shipments.

c. For delivery purposes, multiple orders of most Medical items may be combined in an exterior (shipping) container; each order within the container shall be separately packaged and shall include a properly completed packing list as specified herein. Exterior (shipping) container shall be marked as specified herein.

d. However, medical items requiring special handling (hazardous, controlled, perishable, etc.) shall not be combined with any other items; all items requiring special handling shall be packaged, packed, labeled, and marked in accordance with regulatory requirements and as specified herein.

e. Copies of the latest edition of the Medical Marking Standard No. 1, forms, and various government and industry publications are available upon request. See para. 17.D.

for complete details.

f. The Shipper's Declaration for Dangerous Goods is a red-bordered form and must meet the format, size and color specifications outlined in IATA Dangerous Goods Regulation, Section 8 – Documentation. Supplies of this form are available from commercial vendors who specialize in hazardous material transportation supplies.

2. Special requirements for shipments to Cuba and to the Azores.

a. Orders for Cuba and the Azores shall require shipment through a Military air terminal via military aircraft. In addition to all applicable requirements as specified herein, the following shall apply to shipments of HAZMAT and frozen medical material:

(1) HAZMAT. PPPL&M for HAZMAT shipments to the Azores shall comply with all regulatory requirements and as specified in para. 17.A.13. In addition, packaging and marking of HAZMAT shall comply with AFMAN 24-204(I)/TM 38-250/NAVSUP PUB 505/ MCO 4030.19/DLAI 4145.3, Preparing Hazardous Materiels for Military Air Shipment.

(2) Frozen Medical material. In addition to compliance with all regulatory requirements, a properly completed DD Form 1502 shall be securely affixed to the exterior (shipping) container adjacent to the Military Shipping Label.

b. Clearance shall be obtained prior to shipment. See para. 17.B.6. for complete details.

3. Additional requirements applicable to OCONUS shipments moving on commercial passenger aircraft. In accordance with the Transportation Security Administration (TSA) screening rule effective August 1, 2010, 49 CFR 1544.205(g)(1)(ii), the Secretary of Homeland Security, through the TSA, has been required to establish a system enabling 100% screening of cargo transported on commercial passenger aircraft within, to and from the United States. See para. 17.C. for complete details.

4. Preservation, packaging and packing.

a. Preservation, packaging, and packing shall be sufficient to preclude damage to containers and/or contents thereof under normal shipping and handling conditions. Exterior (shipping) containers shall conform to the applicable carrier's regulations and shall be substantial commercial containers (export when necessary) of the type, size and kind commonly used for the purpose, so constructed as to ensure acceptance and safe delivery by common or other carriers, at the lowest rate, to point of delivery called for in the order. Shipping containers shall comply with National Motor Freight Classification and Uniform Freight Classification, as applicable.

Shipments to OCONUS ordering activities shall be properly packaged and packed for international movement.

b. For non-hazardous items, preservation, packaging, and packing shall be in accordance with ASTM D 3951 (Standard Practice for Commercial Packaging) and as specified therein.

c. For hazardous items, preservation, packaging, and packing shall comply with applicable regulations and as specified herein.

d. Unitized loads shall be used whenever total quantity for shipment to one CONUS/OCONUS destination exceeds 250 lbs or 20 cubic feet. Commercial unitization may be supplied. OCONUS shipments shall be unitized as specified in para. 17.B.4.

5. Certification requirement for Wood Packaging Material (WPM).

a. WPM is defined as wood pallets, skids, load boards, pallet collars, wooden boxes, reels, dunnage, crates, frame and cleats. This definition excludes materials that have undergone a manufacturing process, such as corrugated fiberboard, plywood, particleboard, veneer, and oriented strand board (OSD).

b. All WPM acquired by the Department of Defense (DoD) must meet requirements of International Standards for Phytosanitary Measures (ISPM) 15, “Guidelines for Regulating Wood Packaging Materials in International Trade.” DoD shipments inside and outside of the United States must meet ISPM 15 whenever WPM is used to ship DoD cargo.

c. All WPM shall comply with the official quality control program for heat treatment (HT) or kiln-dried heat treatment (KD HT) in accordance with American Lumber Standard Committee, Incorporated (ALSC) Wood Packaging Material Program and WPM Enforcement Regulations (see http://www.alsc.org/).

d. All WPM shall include certification/quality markings in accordance with the ALSC standard. Markings shall be placed in an unobstructed area that will be readily visible to inspectors. Pallet markings shall be applied to the stringer or block on diagonally opposite sides of the pallet and be contrasting and clearly visible. All containers shall be marked on a side other than the top or bottom, contrasting and clearly visible. All dunnage used in configuring and/or securing the load shall also comply with ISPM 15 and be marked with an ALSC-approved DUNNAGE stamp.

e. Failure to comply with the requirements of this restriction may result in refusal, destruction, or treatment of materials at the point of entry. The Agency reserves the right to recoup from the PV any remediation costs incurred by the Government.

f. Additional information regarding DoD’s WPM requirement is available on the DLA Packaging Website, http://www.landandmaritime.dla.mil/OFFICES/PACKAGING/PALLETIZATION_WPMNOTICE.A

SP

g. NOTE: DoD does not endorse the methyl bromide fumigation program. Only heat treatment or kiln-dried heat treatment of WPM is authorized.

6. Labeling and marking.

a. Materiel shall be marked in accordance with commercial practice and as specified herein.

b. For non-hazardous items and all other routine items, labeling and marking shall be in accordance with commercial practice and as specified herein.

c. For all items requiring special handling, i.e., hazardous, perishable, and sensitive/controlled/pilferable material, labeling and marking shall be in accordance with all applicable regulatory requirements and as specified herein.

http://www.alsc.org/ http://www.landandmaritime.dla.mil/OFFICES/PACKAGING/PALLETIZATION_WPMNOTICE.ASP http://www.landandmaritime.dla.mil/OFFICES/PACKAGING/PALLETIZATION_WPMNOTICE.ASP

d. In addition to all required labeling and marking as specified herein, all OCONUS shipments moving through military channels shall be labeled and marked as specified in the latest edition of the Medical Marking Standard No. 1.

e. The PV shall provide all necessary documentation with each OCONUS shipment, to speed the processing of materiel through the customs process. The required documentation/packing list shall also include Unit Price, TCN, NSN/Part Number/NDC, Nomenclature, DoDAAC, special handling requirement when applicable to material:

Harmonized code/schedule B, Safety Data Sheet (SDS), Hazardous Material Shipper Declarations Sheet, Annotate the packing list with the notation: “REQUIRES SPECIAL HANDLING AND/OR STORAGE” together with applicable storage statements, i.e., “STORE BETWEEN 2° – 8° C (36° - 46° F)”, “KEEP FROZEN”, “FLAMMABLE”, etc. The Controlled Item Identification Code if shipment contains classified, Sensitive, or Protective Items. For shipments of controlled, classified, and pilferable items, the packing list shall be placed inside container no. 1. The container shall be marked with the legend "PACKING LIST HERE" or any similar legend. Point of contact information for the destination customer in order to send a RESHIP. A list of all harmonized codes can be found through https://hts.usitc.gov/

f. Applicable to all Medical items. The product number is the number assigned to the item by the supplier/manufacturer and may be any number which the supplier/manufacturer uses to identify the product, e.g., National Stock Number (NSN), UPN, NDC, catalog number, etc.

g. Applicable to Pharmaceutical items. The Government’s long-term goal is to have a Universal Product Number (UPN) assigned by the original manufacturer or private labeler to all products. The UPN can meet one of three acceptable commercial industry standards. Medical product manufacturers can select either the Health Industry Business Communication Council’s (HIBCC) LIC standard, the Uniform Code Council’s (UCC) SSC-14 format, or the Food and Drug Administration’s National Drug Code (NDC). The bar-coded UPN shall be included on all labels, as applicable.

7. Packing list.

a. A properly completed packing list shall accompany each order. One copy shall be sealed in a suitable water-resistant envelope and shall be affixed on the outside of the shipping container. One copy shall be placed inside the exterior (shipping) container. The packing list shall include, as a minimum, the name of the PV, the DoDAAC and name of the ordering facility, the delivery order number, date of order, itemized list of shipped items by product number/NDC, unit of issue, quantity ordered, quantity shipped, delivered unit price, and the total delivered cost for the order. The product number/NDC used in both the order and confirmation must be duplicated on the packing list. The packing list must be in identical sequence to the delivery order placed by the ordering facility. The delivered unit price will reflect two decimal places (the third decimal place will be rounded down for “4” and below, and will be rounded up for “5” and above). For DLA Distribution Transshipment of medical material, the required documentation/packing list shall also include Unit Price, TCN, NSN/Part Number/NDC, Nomenclature, DoDAAC, special handling requirement when applicable to material: Harmonized code/schedule B, Safety Data Sheet (SDS), Hazardous Material Shipper Declarations Sheet, Annotate the packing list with the notation: “REQUIRES SPECIAL HANDLING AND/OR STORAGE” together with applicable storage statements, i.e., “STORE BETWEEN 2° – 8° C (36° - 46° F)”, “KEEP FROZEN”, “FLAMMABLE”, etc. The Controlled Item Identification Code if shipment contains classified, Sensitive, or Protective Items. For shipments of controlled, classified, and pilferable items, the packing list shall be placed inside container no. 1. The container shall be marked with the legend "PACKING LIST HERE" or any similar legend. Point of contact information for the destination customer in order to send a RESHIP.

b. For all shipments which will move through military channels, or when required by the customer, the packing list shall also include linear bar-coded data (code 3 of 9 or code 39). Bar-coded data shall be included on the packing list in three separate lines of bar coded data, with Human Readable Interpretation (HRI) printed directly below the element. The three separate lines of bar coded data are as follows:

(1) Linear bar codes shall be in accordance with ISP/IEC 16388 (Information Technology – Automatic Identification and Data Capture Techniques – Bar Code Symbology Specification – Code 39).

(2) Bar-coded data shall include the TCN, National Stock Number (NSN), SMS (Medical's routing identifier code), unit of issue, quantity, condition code, distribution code and unit price. This data shall be provided on the packing list in 3 separate linear bar codes (code 39 (also known as code 3 of 9)), together with the corresponding Human Readable Interpretation (HRI), as follows:

1st bar code: TCN 2nd bar code: NSN (in absence of NSN, the CAGE and PN) 3rd bar code: ICP Routing Identifier Code (RIC) - SMS; 2-position unit of issue, 5-position left zero-filled quantity, 2-position zero-filled distribution code, and 6-position left zero-filled unit price

Example:

c. Bar codes may be printed directly on the packing list or on pressure-sensitive label(s) securely affixed to the packing list.

d. At the supplier’s option, bar codes may be supplied on all packing lists for all shipments.

e. In addition, bar codes shall be supplied on the packing list for shipments moving through commercial channels when specifically required by the ordering facility.

8. Destination address label. A destination address label shall be supplied on each exterior (shipping) container.

a. Commercial label.

(1) In addition to all commercial labeling and marking, a commercially-prepared shipping label shall be supplied on all CONUS/OCONUS shipments moving through commercial channels. The PV-generated label may be completed as specified in the latest edition of the

Medical Marking Standard No. 1.

(2) As a minimum, the label shall include the Transportation Control Number (TCN), the requisition number, or the contract/order number, the PV's name and address and the destination address. For DLA Distribution Transshipment of medical material, the TCN, NSN/Part Number/NDC, Nomenclature, DoDAAC/Unit Identification Code (UIC). As application, proper HAZMAT identification, exterior (shipping) containers identified for international transportation shall be marked, labeled, and documented to meet UN requirements in accordance with the appropriate modal regulation. Unless otherwise specified, UN-recommended certification markings for HAZMAT shall be placed on the side of the exterior (shipping) container opposite the side containing the identification, contract data and bar code markings. Regulatory requirement.

Packaging, labeling and marking of hazardous items shall comply with applicable domestic and international transportation regulations, i.e., FED-STD-313, Title 49 Code of Federal Regulation (49 CFR), International Civil Aviation Organization (ICAO) Technical Instructions (excluding para. 1.4 of Chapters 1 and 3), or International Maritime Dangerous Goods Code (IMDG) and International Air Transportation Association (IATA). Marking of hazardous materiel destined for shipment through a military aerial port via military aircraft shall comply with Preparing Hazardous Materials For Military Air Shipments (AFMAN 24-204(I)/TM 38- 250/ NAVSUPPUB 505/MCO 4030.19/DLAI 4145.3). When specified in the order or requested by the customer, additional information, as illustrated on the following sample, may be required on the label:

b. Military shipping label (MSL).

(1) Commercial CONUS/OCONUS shipments. Normally, a bar-coded MSL will not be required on CONUS/OCONUS supplier shipments moving through commercial channels directly to the customer, unless otherwise required by the customer and specified in the order.

However, at the supplier's option, a bar-coded MSL may be supplied on all commercial CONUS/OCONUS shipments.

(2) Military OCONUS shipments. A properly completed bar-coded MSL shall be required on all OCONUS shipments moving through military channels.

(3) MSL requirements. Detailed requirements regarding the MSL are as follows:

(a) The MSL shall be in addition to all commercial and military markings as specified herein and in the order. The MSL shall be securely affixed to each exterior (shipping)

TCN: FM123463260008XXX

NSN/Part Number/NDC Nomenclature HAZMAT Identification label/marking iaw domestic/international regulations (if applicable) MFD EXP (if applicable) From: Contractor’s Name and phone number Ship To: DODAAC Mark For: DODAAC WT CU (weight and cube of the exterior(shipping) container or, for unitized shipments, weight and cube of the unitized load) UOI OF (Unit of Issue, OF how many of that issue)

BOX * OF *

Special Handling Requirements (if applicable) container or unitized load. The MSL supersedes DD Form 1387, which is no longer acceptable for use.

(b) Complete technical requirements for the MSL are contained in MIL-STD-129R paras. 4.2 through 4.2.3, as applicable; this document is available at https://quicksearch.dla.mil/qssearch.aspx. In addition to in-the-clear data elements, 2 types of bar codes, linear (code 39 (also known as code 3 of 9)) and two-dimensional (2D), are required on the MSL, as follows:

(i) In-the-clear data elements. Each MSL shall include the following in-the-clear data elements, unless otherwise indicated:

Transportation Control Number (TCN) PV name and address Ship to address Mark for address, when applicable Date shipped, weight, cube Additional information as specified in the contract or order

(ii) Linear bar codes. Three separate linear bar codes (code 39, also known as code 3 of 9) shall be supplied on each MSL. Each bar code shall have a minimum height of one-half inch, shall be shall be accompanied by the HRI, and shall include the following:

1st bar code: TCN 2nd bar code: Piece number - Do not left zero-fill.

3rd bar code: DoDAAC for the ultimate consignee/mark for consignee

Example:

(iii) 2D bar code. The 2D bar code shall include the TCN; NSN (in absence of the NSN, the CAGE and Part Number), S9M, 2-position unit of issue, 5-position left zero-filled quantity, condition code (shown as "A" unless otherwise specified), and 6- position left zero-filled unit price. Example:

(4) A sample of a completed MSL is provided for information.

https://quicksearch.dla.mil/qssearch.aspx

9. Transportation Special Handling/Protective Services. Certain shipments of non-hazardous medical materiel may require special handing/protective services when being transported by military-controlled aircraft. When applicable, a properly completed DD Form 1387-2 (Special Handling Data/Certification) label shall be affixed to the exterior (shipping) container. The PV shall complete the form by entering all applicable information, and shall firmly affix the completed form adjacent to the Military Shipping Label. Signature block shall be completed by the person preparing the shipment. Copies of this form may be obtained by contacting DLA Troop Support, FSSB (Packaging) via e-mail at fssb@dla.mil.

10. Radio Frequency Identification (RFID).

DoD is amending the DFARS to remove requirements for the use of passive radio frequency identification (RFID) tags for shipments that meet the criteria at DFARS 211.275-2. DoD no longer requires the use of passive RFID tags for shipments due to the use of more cost-effective technologies.

Accordingly, this rule removes and reserves the contract clause at DFARS 252.211-7006, Passive Radio Frequency Identification, which requires contractors to submit advance shipment notices to associate the passive RFID tag with the corresponding shipment, and removes and reserves section 211.275, Passive radio frequency identification. DFARS sections 211.275-1, Definitions; 211.275-2, Policy; and 211.275- 3, Contract clause, are also removed. DFARS clause 252.211-7006 is removed from the list of mailto:fssb@dla.mil solicitation provisions and contract clauses for the acquisition of commercial items at DFARS 212.301.

11. Unique identification (UID).

a. Effective January 1, 2007, UID may be required for certain Medical items if the acquisition cost per unit is more than $5,000, the item is DoD serially managed, mission essential, or a controlled inventory piece of equipment/reparable, the item is a consumable which requires permanent identification, or the item is a component of an end item and UID is required. The requirement for the UID will be determined by the ordering facility, and will be specified in the order, when applicable.

b. Requirements regarding UID will be incorporated into this document when they are finalized. Detailed information regarding UID is available at:

http://www.acq.osd.mil/dpap/pdi/uid/index.html.

12. Materiel requiring special handling. Materiel requiring special handling must be properly identified in order to alert the receiving activity that the materiel requires special handling and storage. In addition to labeling and marking requirements specified herein, the supplier shall annotate the packing list accompanying each shipment with the following notation:

“REQUIRES SPECIAL HANDLING AND/OR STORAGE”, together with the applicable special handling and/or storage statement(s). Examples of special handling and storage statements include the following: “STORE BETWEEN 2o – 8o C (36o – 46o F)”, “KEEP FROZEN”, “FLAMMABLE”, etc. The exterior (shipping) container shall also be marked with the applicable storage statements. For Medical items subject to damage by freezing, marking on each shipping container shall include the statement "DO NOT PERMIT TO FREEZE"; in addition, “ARROW” and “FRAGILE” markings, as appropriate, shall be applied to each shipping container. Pictorial markings may be found in ASTM D 5445. Similar commercial storage statements are acceptable on the packing list, the exterior (shipping) container and the unitized load.

13. Hazardous material (HAZMAT).

a. HAZMAT includes any materiel defined as hazardous under 49 CFR 171.8 (Code of

Federal Regulations (CFR) Title 49) and the latest version of FED-STD-313.

b. Safety Data Sheets (SDSs).

(1) SDSs shall meet the requirements of 29 CFR 1910-1200 (g) and FED-STD-313.

Nothing contained in this contract shall relieve the PV from complying with applicable Federal, State, and local laws, codes, ordinances and regulations (including the obtaining of licenses and permits) in connection with hazardous materiel. Neither the requirements of this contract, nor any act or failure to act by the Government, shall relieve the PV of any responsibility or liability for the safety of Government, contractor, or Subcontractor personnel or property.

(2) The PV shall furnish applicable SDSs as specified herein. If at any time during the contract there is a change in the composition of any item or a revision to FED-STD-313, which renders incomplete or inaccurate the data previously submitted, the PV shall promptly notify the DLA Troop Support Contracting Officer. The Contracting Officer may at his/her option, require the PV to resubmit the revised SDSs to each ordering facility as well as DLA Troop Support, ATTN: FSSB (Packaging). SDSs shall be provided to the customer as follows:

(a) Applicable to CONUS shipments ONLY. In compliance with 29 CFR 1910.1200(g), an SDS shall be provided with each shipment of HAZMAT. In addition, an SDS shall be provided in response to the customer's request.

http://www.acq.osd.mil/dpap/pdi/uid/index.html

(b) Applicable to ALL OCONUS shipments. The PV shall furnish the OCONUS customer with all applicable MSDSs with each shipment of HAZMAT.

(3) A copy of each SDS, annotated with either the National Stock Number, if applicable, or commercial part number, and item name, shall be provided to DLA Troop Support, ATTN: FSSB (Packaging). SDSs will also be provided to the DLA Troop Support Contracting Officer, upon request.

c. Hazard Warning Labels (HWLs). The PV shall also obtain and maintain a file of all applicable Hazardous Warning Labels (HWLs). Each MSDS provided to DLA Troop Support - FSFB (Packaging) and to the DLA Troop Support Contracting Officer shall be accompanied by the HWL, when applicable.

d. Packaging, labeling and marking of HAZMAT.

(1) Packaging, labeling and marking of HAZMAT shall comply with all applicable regulations, i.e., 49 CFR, International Civil Aviation Organization (ICAO) Technical Instructions (excluding para. 1.4 of Chapters 1 and 3), and International Air Transport Association (IATA) Dangerous Good Regulations, and International Maritime Dangerous Goods Code (IMDG). The PV shall insure that all hazardous materiel is packaged, labeled and marked correctly. HAZMAT labeling shall be in accordance with one of the following:

Federal Insecticide, Fungicide, and Rodenticide Act Federal Food, Drug, and Cosmetics Act and regulations promulgated thereunder Consumer Product Safety Act Federal Hazardous Substances Act Federal Alcohol Administration Act or, if the materiel is not subject to one of the above acts, Hazard Communication Standard 29 CFR 1910-1200 et seq.

(2) When required by the ordering facility, HAZMAT shall also be marked as specified in the latest edition of the Medical Marking Standard No. 1.

f. Packaging and marking of HAZMAT for shipment via military air. Proper HAZMAT identification, exterior (shipping) containers identified for international transportation shall be marked, labeled, and documented to meet UN requirements in accordance with the appropriate modal regulation. Unless otherwise specified, UN-recommended certification markings for HAZMAT shall be placed on the side of the exterior (shipping) container opposite the side containing the identification, contract data and bar code markings. Regulatory requirement. Packaging, labeling and marking of hazardous items shall comply with applicable domestic and international transportation regulations, i.e., FED-STD-313, Title 49 Code of Federal Regulation (49 CFR), International Civil Aviation Organization (ICAO) Technical Instructions (excluding para. 1.4 of Chapters 1 and 3), or International Maritime Dangerous Goods Code (IMDG) and International Air Transportation Association (IATA). Marking of hazardous materiel destined for shipment through a military aerial port via military aircraft shall comply with Preparing Hazardous Materials For Military Air Shipments (AFMAN 24-204(I)/TM 38- 250/ NAVSUPPUB 505/MCO 4030.19/DLAI 4145.3). See para. 17.B.1 for a listing of applicable “Ship To Addresses.” Each shipment shall be accompanied by a properly completed standard commercial “Shipper’s Declaration for Dangerous Goods”.

g. Shipper’s Declaration for Dangerous Goods (required for ALL commercial/military air shipments).

(1) This is a standard commercial form with a red border which is available from commercial vendors specializing in HAZMAT transportation supplies. The form must meet the format, size and color specifications outlined in IATA Dangerous Goods Regulations. Each commercial and military air shipment of hazardous items shall be accompanied by a completed Shipper’s Declaration for Dangerous Goods prepared in accordance with each modal requirement for each segment of the shipment.

(2) Applicable to shipments moving to/from/through the United States, Europe, the Middle East and Asia. Emergency point of contact information shall be included on the Shipper's Declaration in the section headed "Additional Handling Information." The complete telephone number shall be listed; the number shall include the international access code, the country code and the city code, so that a call may be made from any international location. The number must be monitored at all times by a point of contact who is knowledgeable about the hazards and characteristics of the HAZMAT, has comprehensive emergency response and accident mitigation information for the HAZMAT or has immediate access to a knowledgeable person.

h. Special shipping instructions. Orders placed for HAZMAT should normally include special shipping instructions. If the PV does not receive special shipping instructions in an order, the PV shall contact the ordering activity. If special shipping instructions apply to the order, the ordering activity shall promptly furnish them to the PV.

i. When shipping hazardous cargo to a transshipment point, the PV shall contact Enterprise Transportation (ET) at (800) 456-5507, fax (717) 770-2701, e-mail delivery@dla.mil for assistance.

14. Protected cargo.

a. To assure that all protected cargo (i.e., sensitive, controlled, or pilferable items), as defined by Federal, State, and Local regulations, can be properly identified by the customer’s receiving point, the PV shall annotate the following statement on its packing list for those orders containing Controlled Substances:

“CONTROLLED SUBSTANCE REQUIRES * STORAGE.”

*PV shall enter the words “VAULT” or “LIMITED ACCESS.”

In accordance with Federal regulations, these items are identified by a distinctive Controlled Substance Schedule Symbol. This symbol appears only on the immediate container or carton.

“VAULT” shall be used for items bearing Symbol C-II; “LIMITED ACCESS” shall be used for items bearing Symbol C-III, C-IV or C-V.

b. Use of the word “narcotics” on shipping containers or packing lists is prohibited.

c. All sensitive/controlled/pilferable items, regardless of whether the item is classified as Schedule II, III, IV or V, shall be shipped via traceable means. Signature service shall be used for all shipments of these items.

d. Hazardous protected cargo. The requirements specified in para. 17.A.13. shall apply to any shipment of a sensitive, controlled, or pilferable item which is also identified as hazardous materiel.

mailto:delivery@dla.mil

15. Perishable Medical Materiel.

a. Packaging, packing, labeling, and marking of perishable medical materiel shall be in accordance with all applicable regulatory requirements and commercial practice, and as specified herein.

b. Perishable medical materiel requiring chill or freeze temperatures shall be properly packaged and packed to ensure that the required temperature shall be maintained during shipment. Required packaging shall be determined by the type of materiel being shipped, the climatic conditions under which the shipment will be made, and the destination's ambient temperature. Prior to preparing perishable medical materiel for shipment, contact the DLA Troop Support Contracting Officer for guidance. DLA Troop Support will conduct a site survey and provide cold chain management training prior to the start of shipping live perishable material.

c. Pharmaceuticals, Vaccines, and In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets requiring constant refrigeration. The following paragraphs regarding refrigerated materials (paras. 17.A.15.c. through 17.A.15.e.) currently apply to OCONUS Prime Vendor shipments only. Reference para. 17.A.15.f. for specific guidance regarding the shipment of refrigerated and frozen materials through the CONUS Prime Vendor.

Pharmaceuticals, Vaccines, and In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets requiring constant refrigeration shall be prepared for shipment in accordance with stringent cold chain management protocols as specified in paragraph 17.A.15.e. These protocols, which have been developed for several weather conditions, as specified herein, are subject to change.

(1) Weather protocols shall be followed when packaging Medical items requiring application of stringent refrigerated cold chain management protocols. Protocols are subject to change. The most up to date protocols are available at: Medical Supply Chain Homepage: click on “I Agree”; select “Pharmaceuticals”; select “Cold Chain Packaging” in the menu on the left side of the page; select “View Packaging Protocols” in the first paragraph.

There are three separate weather protocols: warm weather, moderate weather, or cold weather.

The specific weather protocol to be used shall be determined by the destination's current ambient temperature. Since these weather protocols will change during the term of the contract, the PV shall be required to check this website when the season changes to obtain updates to these weather protocols. For assistance in determining which weather protocol should be used, please contact DLA Troop Support via e-mail at DSCPcoldchain@dla.mil.

(2) Acceptable insulated shipping containers for use with these protocols are listed in TABLE I. Note that the term "CARGO SPACE" is listed in lieu of the term "CAVITY" in TABLE I; this corresponds with the dimensions specified in the protocols. These protocols also require the contractor to use refrigerant packs (gel packs) and the temperature monitor as listed in TABLE II. For each shipment requiring the use of a temperature monitor, the contractor shall also include a Temperature Monitor Return Package (TMRP) with the shipment. DLA Troop Support will provide the contractor with the TMRPs. Each TMRP includes customer instructions for return the Temperature Monitors to DLA Troop Support, a prepaid/preaddressed shipping air bill, and a shipping pouch. Suggested sources for the containers, refrigerant packs, and temperature monitors are listed at the Medical Supply Chain Homepage. Additional information, to include specific requirements applicable to all shipments of MMR, Oral Typhoid, and Botox are in NOTE 1 below:

mailto:DSCPcoldchain@dla.mil https://www.medical.dla.mil/Portal

TABLE I - INSULATED SHIPPING CONTAINERS) 1/

PRODUCT NO.

DIMENSIONS (Length x Width x Height) APPROXIMATE

WEIGHT

(FULLY

LOADED) CARGO SPACE OUTER CONTAINER

Extra Large 18" x 14 1/2" x 12" 24" x 24" x 24" 145 lbs

Large 16-1/2" x 12" x 7"” 22-1/2" x 19" x 17-1/2" 75 lbs

Medium 12" x 6-1/2" x 6-1/2" 18" x 12" x 18" 40 lbs

Small

10-3/4" x 6-12" x 4"

15-1/2" x 12" x 14"

20 lbs

1/ These containers are designed for use for "ANY TEMPERATURE-SENSITIVE PRODUCT" and must be used in accordance with the Packaging Protocols as identified above. These containers should maintain the required temperature as indicated in the applicable protocol for at least 72 hours during shipment.

TABLE II - ADDITIONAL SUPPLIES 2/

Refrigerant Packs

SIZE WEIGHT DIMENSIONS

Small 24 oz 8" x 6" x 1-1/4" Medium 48 oz 10-1/4" x 8" x 1-1/2"

Temperature Monitors TempTale®4 (TT4)

2/ Pre-cool (condition) applicable containers, gel packs, and temperature monitors to 4º C for at least 24 hours prior to packaging and closing. Frozen gel packs, when applicable, must be conditioned at -17º C to -20C for at least 24 hours prior to packaging and closing. Packaging will be done in refrigeration and removed prior to closing.

NOTE 1: APPLICABLE TO MMR, ORAL TYPHOID, and BOTOX.

The prime vendor shall pack containers utilizing the Hybrid Packaging Protocols and utilize yellow- labeled TT4s (Catalog # T4400-02-360); all frozen gel packs (conditioned for at least 24hrs at -20 degrees C), cargo space requirements, fiberboard barrier, and foam plug, as specified in the existing Cold Chain protocols, shall still be used. All of the in-transit instructions, and customer receiving procedures shall remain unchanged. All startup delays and procedures shall be the same.

DD Form 3035-2 yellow label shall still be completed with the following information:

Packager’s name Date of packing The requirement for the 5-day-out-refrigeration date shall be filled in.

The Hybrid TT4 instruction sheet and FedEx materials shall also be included.

(3) The PV shall affix the Appropriate DD Form 3035 Cold Chain Shipping Label to the upper right-hand corner of the container’s lid on each insulated container. The label shall be accurately completed in its entirety; for example, Instruction 1) - “Refrigerate Container in-transit If After This Date”, must be completed as follows: If the shipment was packaged on March 1, the “Refrigerate Container in-transit If After This Date” will be March 6. For supplies of this label, contact DLA Troop Support via e-mail at DSCPcoldchain@dla.mil.

(4) DD Forms 1502/1502-1/1502-2 and 1502N/1502-1N/1502-2N shall not be used for shipments of Temperature Sensitive materiel packaged in accordance with stringent cold chain management protocols.

d. Orders for Temperature Sensitive Products. Temperature Sensitive products shall always be ordered under a separate call number. Additionally, orders for MMR, Oral Typhoid, and Botox should also be placed on separate call numbers due to their modified packaging requirements. For orders that contain Temperature Sensitive products, depending on the destination, the PV shall ship on Mondays and/or Fridays only (NOTE: Thursdays for Guam) to ensure that shipments of Temperature Sensitive products do not arrive on a weekend or are not delayed while intransit. NOTE: The contractor shall not ship over a holiday.

e. Complete packaging protocols for use with Refrigerated items are available at: Medical Supply Chain Homepage

f. CONUS Temperature Sensitive Shipments. For the shipment of pharmaceuticals, vaccines, and In-Vitro diagnostic substances, reagents, test kits and sets requiring constant refrigeration or freezing temperatures within the Continental United States (to include Hawaii) the PV shall use one of the following acceptable commercial-off-the-shelf insulated shipping containers, together with the accompanying validated packaging protocols:

AcuTemp:

Large - Part# 710009-03- 48 Medium - Part# 710009- 02-48 Small - Part# 710009-01-48

Minnesota Thermal Science:

Large - Credo Series 4-2896 (Part# CR28A42896) Medium - Credo Series 4-1296 (Part# CR12A41296) Small - Credo Series 4-496 (Part#

CR04A4496)

The acceptable shipping containers are reusable. The PV shall coordinate with each ordering facility regarding the return of all shipping containers to the PV. The PV shall coordinate with the applicable container vendor regarding the requirements necessary for reuse of the shipping container.

For each shipment, the PV shall also include one of the following temperature monitoring devices as well as a Temperature Device Instruction Sheet (TDIS) with the shipment. DLA Troop Support will provide the PV with the TDISs. Each TDIS includes customer instructions for utilizing the temperature monitoring devices:

TempTime:

TransTracker CF - Part# TBD

ShockWatch:

Cold Chain Complete - Part# TBD

If the PV already has qualified packaging solutions that are validated for 2-8C and -15C to -25C for a minimum of 48hrs, and an industry acceptable temperature monitoring device already in use, they may submit proof of that packaging validation and device details to DLA for approval.

DD Forms 1502/1502-1/1502-2 and 1502N/1502-1N/1502-2N shall not be used for shipments of Temperature Sensitive materiel packaged in accordance with stringent cold chain management protocols.

Orders for Temperature Sensitive Products. Temperature Sensitive products shall always be ordered under a separate call number.

g. Pharmaceuticals, Vaccines, and In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets requiring freezing temperatures The following paragraphs regarding frozen materials currently apply to OCONUS Prime Vendor shipments only. Reference para. 17.A.15.f.

for specific guidance regarding the shipment of refrigerated and frozen materials through the CONUS Prime Vendor. Pharmaceuticals, Vaccines, and In-Vitro Diagnostic Substances, Reagents, Test Kits, and Sets requiring a constant freezing state (-15C to -25C) shall be prepared for shipment in accordance with stringent cold chain management protocols as specified in paragraph 17.A.15.e. These protocols, which have been developed for all weather conditions, as specified herein, are subject to change. Perishable Medical items requiring constant freeze temperatures (- 15C to -25C) shall be packaged and marked as follows:

(1) (Medical items which are identified as freezer products shall be stored and shipped in a constant frozen state. Packaging protocols shall be followed when packaging Medical items requiring application of stringent frozen cold chain management (-15C to -25C). Protocols are subject to change. The most up-to-date protocols are available at Medical Supply Chain Homepage.

Protocols are a universal pack out. Diluents and component parts of freezer products shall be packed in separate containers normally used for non-freezer products. Set assembly markings shall be used in these cases. For assistance with protocols, please contact DLA Troop Support via e-mail at DSCPcoldchain@dla.mil

(2) Acceptable insulated shipping containers for use with these protocols are listed in TABLE I above. These protocols also require the contractor to use only frozen Phase Change/ water-based hybrid coolant material (bricks) and the temperature monitor as listed in TABLE IV. For each shipment requiring the use of a temperature monitor, the contractor shall also include a Temperature Monitor Return Package (TMRP) with the shipment. DLA Troop Support will provide the contractor with the TMRPs. Coolant material shall be preconditioned in a -30° C freezer for at least 24hrs before packaging. Suggested sources for the containers, coolant bricks, and temperature monitors are listed are listed at the Medical Supply Chain Homepage.

TABLE IV - ADDITIONAL SUPPLIES 2/

PCM/Gel Hybrid Bricks

SIZE WEIGHT DIMENSIONS

420 24 oz 7.5" x 6.1" x 1"

Temperature Monitors TempTale®4 (TT4)

2/ Pre-cool (condition) bricks to -30º C and temperature monitors to -20C for at least 24 hours prior to packaging and closing.

https://www.medical.dla.mil/Portal mailto:DSCPcoldchain@dla.mil

Containers will be preconditioned at room temperature and packaging and closing will be done at room temperature. Frozen bricks will be benched at room temperature for 30 minutes prior to packaging and closing.

(3) The PV shall affix the appropriate DD Form 3035 Cold Chain Shipping Label to the upper right-hand corner of the container’s lid on each insulated container. The label shall be accurately completed in its entirety; for example, Instruction 1) - “Freeze Container in-transit If After This Date”, must be completed as follows: If the shipment was packaged on March 1, the “Freeze Container in-transit If After This Date” will be March 6. For supplies of this label, contact DLA Troop Support via e-mail at DSCPcoldchain@dla.mil.

(4) DD Forms 1502/1502-1/1502-2 and 1502N/1502-1N/1502-2N shall not be used for shipments of Temperature Sensitive materiel packaged in accordance with stringent cold chain management protocols.

B. Additional requirements applicable to shipments to OCONUS customers via military channels.

1. In addition to all requirements specified herein, additional packaging and marking requirements and shipping instructions shall apply for OCONUS shipments through defense consolidation points, water ports or military air terminals. Please contact the DLA Troop Support Contracting Officer for SHIP TO address information.

2. Shipments to Cuba and to the Azores shall be sent through military air channels.

Therefore, packaging and marking of all shipments of HAZMAT and frozen items shall also comply with all applicable requirements for military shipments as specified in para. 17.A.13.f. All shipments shall also require a properly completed Military Shipping Label as specified in para.

17.A.8.b.

3. For all OCONUS customers, in addition to all requirements specified herein, the following packaging requirements shall apply:

a. Separate overpacks shall be prepared for each ultimate OCONUS destination. The PV shall be responsible for packaging and overpacking the materiel in suitable export containers as specified in para. 17.A.4.

b. OCONUS shipments shall be unitized as specified herein. Wooden pallets and packaging materials shall be heat-treated and certified as specified in paragraph 17.A.5.

c. For USAMMCE shipments, the PV shall supply 40-inch x 48-inch, 4 way entry, stringer winged pallets.

4. Unitization/Consolidation. Items for a single ordering facility shall be consolidated into larger air shipment configurations in accordance with the applicable carrier’s requirements. For other situations, the PV shall comply with the carrier’s requirements involving shipment via air.

Recommended configurations of unitized loads are as follows:

a. Shipments weighing less than 70 lbs. Consolidate materiel into suitable sealed boxes acceptable for overseas air shipment.

b. Shipments weighing 70 lbs – 299 lbs. Prepare shipments by using one of the following means:

(1) Consolidate materiel into suitable sealed boxes acceptable for overseas air shipment.

(2) Unitize materiel on commercial pallets, 40 inches long by 48 inches wide.

Overhang is permitted; however, overhang shall not exceed 2 inches, resulting in maximum dimensions of 42 inches long by 50 inches wide, including overhang. When overhang occurs, it shall be uniform on each side; i.e., a pallet load measuring 41 inches by 49 inches shall have an overhang of one-half inch on each side. Total height of pallet load, including the pallet, shall be 60 inches. To insure stability of the load, whenever possible, the load shall be formed by interlocking containers in a suitable pattern wherever possible. To avoid damage to boxes and/or contents, place boxes containing heavier items on the bottom of the load. Fill in any voids or gaps with appropriately shaped fiberboard storage aids, i.e., separator support, chimney filler, etc. When necessary to even the sides of the load, full-height edge protectors shall be used. Place a suitable piece of fiberboard or a fiberboard cap on top of the load prior to bonding. Bonding shall conform to applicable carrier regulations for shipments from the PV to the receiving point for storage and later reshipments. Loads may be bonded by any of the following methods:

(a) Shrink-wrapping. The preferred method of applying shrink-wrap is mechanically on a turntable-type machine. As an alternate, hand shrink-wrapping is acceptable, provided sufficient shrink-wrap is used and the load is completely and securely wrapped as stated herein. To further guard against breaking and shifting of the load contents, suitable plastic straps may be applied over the shrink-wrap.

(b) Strapping. Strapping may be metallic or nonmetallic. Strapping shall conform to normal commercial practice. All straps shall be applied straight and shall be tensioned equally to preclude looseness on the side or top of the load and prevent excess strain on some straps that may cause looseness or breaking during handling and shipment. Straps shall be held in tension by appropriate seals.

(c) Other. As an alternate, loads may be bonded by any acceptable commercial method.

c. Shipments weighing 300 lbs or more. Materiel shall be unitized on commercial pallets as specified in para. 17.B.4.b.(2).

d. Unitized loads not meeting the 60-inch height requirements. Due to the size of the shipment, some palletized loads may not meet the 60-inch height requirement. To ensure that these shorter palletized loads are not stacked, a suitable internationally acceptable pictorial marking, which indicates that stacking is not permitted, shall be applied to at least two adjacent sides of each load. Pictorial markings may be found in ASTM D 5445 (Standard Practice for Pictorial Markings for Handling of Goods).

e. Alternate unitization. As an alternate for all configurations, materiel may be unitized in suitable containers supplied by the carrier.

5. Labeling and marking requirements. In addition to all required labeling and marking as specified herein, the following shall apply to all shipments moving through any defense consolidation point or military air terminal:

a. The TCN and the MARK FOR address (correct DoDAAC and the name of the Medical Ordering Facility) shall be shown on the inner package, the packing list, the exterior (shipping) container, and the MSL.

b. The TCN is necessary to identify, control and trace a shipment from origin to ultimate consignee. An example is FM5604-6326-0008XXX for a complete order that is being sent in one shipment to an overseas Air Force medical ordering activity. Without a TCN, a shipment may end up as frustrated cargo, especially at a transshipment point. The "MARK FOR" entry is required to identify the ultimate destination. All TCN and MARK FOR information will be provided in the order.

c. In lieu of a contractor-generated commercial address label, a bar-coded MSL shall be supplied on all contractor shipments moving through any defense consolidation point or military air terminal. The bar-coded MSL shall be securely affixed to the exterior (shipping) container or unitized load and shall be completed as specified in para. 17.A.8.b.

d. When required, a passive RFID tag shall be supplied on each shipment, as specified in para. 17.A.10.

e. The contractor shall provide all necessary documentation to speed the movement of materiel through the customs process.

6. Shipments moving through military air terminals. The following shipping instructions shall also apply to all shipments moving through military air terminals:

a. All suppliers who ship to overseas medical facilities by military air must call for an air clearance.

b Shippers must obtain permission to ship controlled substances by military air. If approved, Signature Tally Service is required. Approval can be obtained when calling for an air clearance (See para. 17.B.6.c.).

c. It is mandatory that all shipments to Air Mobility Command (AMC) air channels obtain shipment clearance from the Service Air Clearance Authority 24 hours prior to arrival. To obtain clearance, the shipper must contact Enterprise Transportation (ET) at (800) 456-5507, fax (717) 770-2701, e-mail delivery@dla.mil, and provide the following information:

(1) DoDAAC (ET will provide a Transportation Control Number (TCN)).

(2) Date of shipment, mode and number of days en route.

(3) Number and type of containers, weight and cube.

(4) Special handling instructions (e.g., perishable,…