Pharmacy Distribution Center Label and Marking Overview

When dealing with pharmaceuticals, proper labeling and marking is of the utmost importance. Due to the sensitive nature of these products and their importance to be properly represented at every step of the transport, distribution and retail steps- we have outlined helpful guidance to properly labeling and marking pharmaceuticals.

 

Inner Pack Markings

Inner packs are warehouse packs that will be broken out and sent to individual stores
by the distribution center. Inner packs are required to be properly secured so the single selling units do not come loose during the order fulfillment process. National retailers, such as Walmart, require that each Prescription Drug’s lowest saleable unit is labeled according to the Healthcare Distribution Alliance (HDA).

Applicable Rx products must also contain a 2D GS1 DataMatrix containing the DSCSA product identifier attributes (GTIN, no caps).

 

Pharmacy Case Label and Marking Guidelines

In addition to the specifics surrounding the inner pack markings of pharmaceuticals, large retailers also require specific protocols for labeling cases. Again, we defer to regulations set forth by one of the world’s largest retailers, Walmart, as somewhat of an unofficial authority for these matters. When their requirements are met it is all but certain that the labels, marking, and coding will meet standards set forth by other retailers and distributors.

Walmart requires that each Prescription Drugs’ homogeneous case is labeled according to the Healthcare Distribution Alliance (HDA) “Guidelines for Barcoding in the Pharmaceutical Supply Chain.”

A combination of both GS1-128 and GS1 DataMatrix are required to be used at the homogeneous shipping case level. Homogeneous cases are required to unambiguously identify the product trade name, strength, GTIN, lot/expiration date, and quantity contained in the case. All refrigerated products are required to be clearly labeled and separated from ambient products. All cases containing fragile merchandise are required to be clearly marked with a graphic icon depicting the fragility of the merchandise.

Online item files are required to reflect what is printed on the vendor case pack. Verify that the information printed on the case matches the Walmart Retail Link. Product identification labels are required on a minimum of two adjacent sides on each case. Use a wraparound label or use two separate but identical labels on adjacent sides.

Once the label is affixed to the case, ensure that there is a sufficient barcode “quiet zone” in the center of the label and that the barcodes on both halves are readily scannable. Case labels should be no closer than 1.25″ from the bottom of the case. Affixing a case label to the top or bottom of the case is NOT ALLOWED.

 

Pharmacy Distribution Centers Shipping Label and Packing List

 

Shipping Label Guidelines

Walmart Pharmacy distribution centers require that a Serialized Shipping Container Code (SSCC) label is affixed to each individual shipping mix case or pallet.

Standard shipping labels are required to contain the following:

• Ship from address: Supplier’s address, city, state, and zip code
• Ship to address: Distribution Center address, city, state, and zip code
• To postal barcode (optional)
• Carrier name (if available)
• Pro number (if available)
• BOL number (if available)
• Facility/location (5 digits)
• Walmart DC number, e.g., 06001
• PO number (10 digits)
• Walmart item number (WMIT)
• NDC number or “MIXED” if case or pallet has mixed SKUs
• Quantity – number of cases contained on the pallet
• GS1-128 barcode containing an 18-digit SSCC code

 

Packing List

Packing lists are required to be attached to the outside of the last box/pallet loaded on the trailer. Required to be facing outward on the pallet or box in clear view of the unloader. A second packing slip should be made available to the carrier with the BOL and the freight bill for presentation at the warehouse receiving area. If shipping LTL, a packing slip is required to be attached to the outside of one case for each purchase order.

The packing list is required to contain the following:

• PO number
• Ship to name and address
• Shipper’s name and address
• Product name, strength, dosage form, container size
• National Drug Code (NDC)/Vendor Stock number
• Lot number
• Case count per item
• Total case count shipped

Each pallet, with either mixed products or purchase orders, is required to have a container list identifying the POs, items, and quantities on that pallet.

AMI is happy to assist in all matters regarding the labeling, marking and coding of pharmaceuticals. We offer a variety of products that can be used to meet these labeling requirements whether it’s at manufacturing, during transportation, or at the retail end of things. Browse our comprehensive guides to a plethora of labeling, coding, and marking protocols.