@repo/shared / DrugsType
Interface: DrugsType
FDA Drugs and Pharmaceuticals PGA data for CBP entry summary filings.
Required for imports of prescription drugs, OTC drugs, investigational drugs, and Section 804 importation program products regulated by FDA's Center for Drug Evaluation and Research (CDER). Covers FDA product codes, source countries, entity roles, and affirmations of compliance.
Properties
| Property | Type | Description |
|---|---|---|
affirmations? | {code?: | "DA" | "REG" | "DLS" | "IND" | "FSR" | "PRN" | "ERR" | "PLR" | "IFE" | "LST" | "PM#" | "IDE";qualifier?: string;}[] | Affirmation of Compliance entries. Repeatable, but each AoC code only once. Which codes are mandatory/optional depends on processingCode and intendedUseCode. Per CATAIR FDA 08-25.pdf, section 7.11, Tables 7-18 and 7-19. |
apiProducerEntity? | EntityReference | API Producer / Drug Substance Manufacturer (role code: GD). Optional for DRU per Table 7-14. Repeat for each API producer. PG19 Entity Name + Address 1 mandatory if provided; PG20 City + Country mandatory if provided. |
arrivalInfo? | {arrivalDate?: Date;arrivalTime?: string;inspectionLocation?: string;inspectionLocationCode?: string;statusCode?: "A" | "F";}[] | Anticipated arrival information. At least one PG30 with status "A" is mandatory. For entry type 21 from FTZ, an additional PG30 with status "F" and FIRMS code is required. Per CATAIR FDA 08-25.pdf, section 7.15, Table 7-25. |
brandName? | string | Trade/Brand Name for the drug product. Optional for Drugs per Table 7-9. Up to 35 characters. Per CATAIR FDA 08-25.pdf, section 7.6: Optional (O). |
constituentElements? | {isActiveIngredient?: boolean;name?: string;percentage?: number;quantity?: number;unitOfMeasure?: string;}[] | Product Constituent Elements (active ingredients). Optional for DRU, but if transmitting, name + quantity + (UoM or percent) are required. Repeatable for each active pharmaceutical ingredient in the dosage form. Per CATAIR FDA 08-25.pdf, Table 7-7. |
correctionIndicator? | boolean | Correction Indicator for submitting a corrected PGA Message Set. Per CATAIR FDA 08-25.pdf, Table 7-3: position 79, Optional (O). |
deliveredToEntity? | EntityReference | Delivered-To Party (role code: DP). Mandatory for DRU per Table 7-11. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. |
disclaimer? | "A" | "F" | Disclaimer code when a full PGA Message Set is not being provided. "A" = product not regulated by FDA. "F" = US-manufactured, never left US (Entry Type 21 only). When disclaiming, govAgencyProgramCode and processingCode should both be "FDA". Per CATAIR FDA 08-25.pdf, Table 7-3: position 80, Conditional (C). |
fdaImporterEntity? | EntityReference | FDA Importer of Record (role code: FD1). Mandatory for DRU per Table 7-11. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. PG21 is also mandatory: at least one individual contact with name, phone, and email. |
intendedUseCode? | | "080.012" | "100.000" | "110.000" | "130.000" | "130.033" | "150.007" | "150.013" | "150.017" | "155.009" | "180.009" | "180.017" | "180.018" | "180.026" | "920.000" | "970.000" | "980.000" | Intended Use Code identifying the purpose for importing the drug product. Determines which AoC codes are required, optional, or exempt. Per CATAIR FDA 08-25.pdf, Table 7-3: positions 42-57, Conditional (C). |
lotDetails? | {lineValue?: number;lotNumber?: string;productionEndDate?: Date;productionStartDate?: Date;temperatureQualifier?: "A" | "D" | "R" | "P" | "F" | "H" | "U";}[] | Product condition / lot details. Repeatable for multiple lot numbers. Per CATAIR FDA 08-25.pdf, section 7.13, Table 7-22. |
manufacturerEntity? | EntityReference | Manufacturer of goods (role code: MF). Mandatory for DRU per Table 7-11. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. |
packaging? | {packagingQualifier?: number;quantity?: number;unitOfMeasure?: string;}[] | Product packaging details. Up to 6 packaging levels (outermost=1 to innermost=6). Conditional for Drugs per section 7.14. Per CATAIR FDA 08-25.pdf, Table 7-23. |
pointOfContactEntity? | EntityReference | Point of Contact / Filer/Broker (role code: PK). Optional for DRU per Table 7-15. Submitted as a PG21-only record (no PG19/PG20). User picks a specific individual contact. |
processingCode? | "PRE" | "INV" | "RND" | "PHN" | "OTC" | "804" | Government Agency Processing Code for the drug filing. Identifies the regulatory sub-category of the drug product. PRE = Prescription, OTC = Over the Counter, INV = Investigational, PHN = Pharmaceutical Necessities, RND = Research and Development, 804 = Section 804 Importation Program. Per CATAIR FDA 08-25.pdf, Table 7-3: positions 14-16, Conditional (C). |
productCodeNumber? | string | FDA Product Code Number identifying the product being imported. Must be exactly 7 characters. One product code per PGA line. Per CATAIR FDA 08-25.pdf, Table 7-5: positions 10-28, Mandatory (M). |
productDescription? | string | Product description: common, market, or usual name. Free-form invoice description (not the product code description). Per CATAIR FDA 08-25.pdf, Table 7-10: positions 24-80, Mandatory (M), up to 57 chars. |
remarksText? | string | Remarks text for the drug filing. Free-form text relevant to the shipment or commodity. Only one PG24 allowed per FDA line. remarksTypeCode is always "GEN" (hardcoded by encoder). Per CATAIR FDA 08-25.pdf, Table 7-21: positions 13-80, Optional (O), up to 68 chars. |
shipperEntity? | EntityReference | Shipper (role code: DEQ). Mandatory for DRU per Table 7-11. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. |
sourceCountries? | {countryCode?: string;sourceTypeCode?: "30" | "39" | "294";}[] | Product source/origin entries. Repeatable for multiple source countries. At least one PG06 with source type 30 or 39 is mandatory for Drugs. Per CATAIR FDA 08-25.pdf, Table 7-8. |
sponsorEntity? | EntityReference | Sponsor (role code: SPO). Optional for DRU per Table 7-14. PG19 Entity Name + Address 1 mandatory if provided; PG20 City + Country mandatory if provided. |