Upload Manufacturer Instrument File

Manufacturers have two ways of uploading data into the Closed340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA).. Data can be uploaded as a fixed length .txt instrument file or the data can be entered manually. If a manufacturer decides to upload their data as a fixed length .txt instrument file, it must be in the .txt file format identified in the chart below.

Instrument File in Text File Format (.txt)
Field Size Starting Column Ending Column Data Type Constraints/Remarks
ClosedNDC A unique 11-digit, 3-segment code numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment (4 or 5 digits) is assigned by the Food and Drug Administration (FDA). The second segment (3 or 4 digits) identifies a specific strength, dosage form, and formulation for a particular firm. The third segment (1 or 2 digits) identifies package forms and sizes. 11 1 11 String  
Labeler Code 5 1 5 String Digits 1-5 of the NDC
Product Code 4 6 9 String Digits 6-9 of NDC
Package Size Code 2 10 11 String Digits 10 and 11 of NDC
Period Covered 5 12 16 String QYYYY (Quarter/Year)
AMP 12 17 28 Double 99999.999999
ClosedURA The CMS Medicaid Drug Rebate (MDR) system performs the URA calculation using the drug manufacturer's pricing. The specific methodology used is determined by law and depends upon the drug's classification. Drug manufacturers remain responsible for correctly calculating the URA for their covered outpatient drugs. 12 29 40 Double 99999.999999, after the decimal round to 4 digits then pad with zeros for positions 5 & 6
Package Size 11 41 51 Double 9999999.999
Unit Type 3 52 54 String e.g., TAB, CAP, ML
Case Package Size 11 55 65 Double 99999999999
340B ClosedCeiling Price Manufacturers who participate in the Medicaid Drug Rebate Program (MDRP) enter into an agreement with the Secretary of Health and Human Services under which the manufacturer must agree to charge a price no greater than the statutory pricing formula (340B ceiling price) when selling covered outpatient drugs to 340B covered entities. In order to calculate the 340B ceiling price, the Unit Rebate Amount (URA) is subtracted from the Average Manufacturer Price (AMP) for the smallest unit of measure [340B Ceiling Price = (AMP – URA)]. Under section 340B(a) of the Public Health Service Act (PHSA), the 340B ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure of each covered outpatient drug (as identified by the product's 11-digit National Drug Code (NDC). To ensure that the final price is operational in the marketplace, HRSA then multiplies this amount by drug's package size (PS), defined as the number of billing units in the labeled quantity from which the pharmacist dispenses, and the case pack size (CSP), defined as the number of salable units in the shipping container [340B Ceiling Price = (AMP-URA) x PS x CSP]. 12 66 77 Double 999999999.99
FDA Product Name 65 78 142 String FDA Product Name
Labeler Name 39 143 181 String Name of MFR/Labeler
WAC 12 182 193 Double 999999999.99

  1. Select Manufacturer Quarterly Upload then Upload Manufacturer Instrument File to upload your quarterly pricing data during the manufacturer submission period. A manufacturer can upload multiple files multiple times during the quarterly submission period. The latest uploaded data for a specific NDC will override the previous data for a specific NDC and reconciliation tasks will be created based on the latest data uploaded for a specific NDC.

  2. The Manufacturer File Upload page is displayed below.

    Manufacturer File Upload

  • Select the Sales Year and Sales Quarter to match the year and quarter of the data upload file.

  • Click the blank box or the Select button to locate and open the instrument file.

    Select button for Manufacturer Data File Location

  • Click the Select button.

  • Selecting the file will start the upload immediately.

  • The file will appear on the Manufacturer File Upload page with a Remove link to allow you to remove it and select a different file.

  • The Analyze Data button will be enabled.

  1. The Data Upload Analysis page displays the file statistics for the upload, the number of rows inserted into the database, and the number and type of .txt file errors. Rows with identified errors will not be processed. There are different options to address file errors before selecting Process File.

  • Create a new instrument file with the identified errors corrected and upload it. The 340B OPAIS accepts the most recently uploaded data for each NDC. In other words, the 340B OPAIS will overwrite any previously submitted data for an NDC.

  • Create a new instrument file that contains all required fields for each NDC that had an identified error in the previous upload. Upload this second instrument file and the 340B OPAIS will accept the most recently uploaded data for each NDC in the file. Previously submitted data for different rows/NDCs will not be deleted or overwritten in the 340B OPAIS.

  • Manually enter data for each NDC that had an identified error.

    Data Upload Analysis

  1. Upon clicking the Process File button, the system processes and loads the records, and displays the Processing Upload page.

    Processing Upload page

  1. Return to the dashboard to view the quarterly submission progress status.

Click the small arrows to expand/collapse the list to display error details. The table below displays commonly encountered error messages.

Manufacturer Instrument File – Upload Error Messages
Error Message Description
"This combination of NDC, SalesYear and SalesQuarter was not found in the ClosedFDB First Databank, Inc., is the publisher of pharmaceutical information that is used within healthcare information systems serving hospitals, physician practices, other providers, payers, retail pharmacies, state health programs, and others for the purpose of medication decision support and negotiating reimbursement rates paid to pharmacies and other providers. file" The drug code is not present in the FDB file for the specified sales quarter and sales year.
"Supplied Ceiling Price does not match Calculated Ceiling Price" There is a mismatch between the ceiling price in the Instrument file and the ceiling price calculated by OPAIS using the AMP and URA in the file.
"This Labeler Code is not allowed for this user" Manufacturer is not allowed to submit the prices for this Labeler Code.
"NDC is not available for reporting this period.” Manufacturer is not allowed to submit the prices for this drug code.