@repo/shared / BiologicsType
Interface: BiologicsType
FDA Biologics PGA data for CBP entry summary filings.
Required for imports of biological products (vaccines, blood products, tissues, cell and gene therapies, etc.) regulated by FDA's Center for Biologics Evaluation and Research (CBER). Covers FDA product codes, source countries, entity roles, lot numbers, and affirmations of compliance.
Properties
| Property | Type | Description |
|---|---|---|
brandName? | string | Trade or brand name of the product. Per CATAIR FDA 08-25.pdf, Table 5-9: Conditional (C), Not Repeatable. Conditional based on processing code — required for most Biologics sub-types. |
containerNumbers? | {containerNumber?: string;}[] | Array of shipping container number entries. Per CATAIR FDA 08-25.pdf, Table 5-26: Optional (O), Repeatable. Each container number is up to 20 alphanumeric characters. |
correctionIndicator? | boolean | Indicator for filing a correction to a previously submitted PGA Message Set. Per CATAIR FDA 08-25.pdf, Table 5-3: position 79, Optional (O). For future use. |
deliveredToEntity? | EntityReference | Delivered-To Party (role code: DP). Mandatory for BIO per Table 5-11. 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 declaring that a full PGA Message Set is not being provided. "A" = product not regulated by FDA. "F" = manufactured in US and never left. Per CATAIR FDA 08-25.pdf, Table 5-3: position 80, Conditional (C). |
fdaImporterEntity? | EntityReference | FDA Importer of Record (role code: FD1). Mandatory for BIO per Table 5-11. 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. |
govAgencyProcessingCode? | "ALG" | "BLO" | "HCT" | "VAC" | "XEN" | "BDP" | "BLD" | "BBA" | "PVE" | "CGT" | Government Agency Processing Code identifying the CBER-regulated commodity sub-type. Per CATAIR FDA 08-25.pdf, Table 5-3: positions 14-16, Conditional (C). Mandatory unless the line is disclaimed (in which case govAgencyProcessingCode = "FDA"). Valid values: ALG, BBA, BDP, BLD, BLO, CGT, HCT, PVE, VAC, XEN. |
intendedUseCode? | | "080.000" | "082.000" | "110.000" | "150.007" | "155.000" | "170.000" | "180.000" | "180.009" | "180.014" | "180.015" | "180.016" | "920.000" | "940.000" | "970.000" | Code identifying the intended use for the commodity after importation. Per CATAIR FDA 08-25.pdf, Table 5-3 and Table 5-4: positions 42-57, Conditional (C). Mandatory unless the line is disclaimed. |
lotNumbers? | {lotNumber?: string;}[] | Array of lot number entries. Repeatable for multiple lot numbers. Per CATAIR FDA 08-25.pdf, Table 5-22: Optional (O), Repeatable. lotNumberQualifier is always 1 (Manufacturer) for Biologics — hardcoded by encoder. |
manufacturerEntity? | EntityReference | Manufacturer of goods (role code: MF). Mandatory for BIO per Table 5-11. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. |
pg04? | {constituentActiveIngredient?: boolean;constituentName?: string;constituentPercentage?: number;constituentQuantity?: number;constituentUnitOfMeasure?: string;}[] | Optional array of constituent/active ingredient details. Per CATAIR FDA 08-25.pdf, Table 5-7: Optional (O), Repeatable. If opting to transmit this record, constituentName is required at minimum. |
pg06? | {countryCode?: string;sourceTypeCode?: "30" | "39" | "294";}[] | Array of source/origin information entries. Per CATAIR FDA 08-25.pdf, Table 5-8: Mandatory (M), Repeatable. At least one entry with sourceTypeCode 30 or 39 is required. sourceTypeCode 294 (Country of Refusal) is optional if applicable. |
pg23? | {affirmationOfComplianceCode?: "HCT" | "STN" | "DA" | "REG" | "DLS" | "IND" | "IFE" | "BLN" | "CPT" | "HRN";affirmationOfComplianceQualifier?: string;}[] | Array of affirmation of compliance entries. Per CATAIR FDA 08-25.pdf, Table 5-17 and Table 5-18: Conditional (C), Repeatable. Each AoC code can only be transmitted once per PGA line. Some codes are "indicator only" (no qualifier needed), others require a qualifier string. |
pg26? | {packagingQualifier?: number;quantity?: number;unitOfMeasure?: string;}[] | Array of packaging detail entries. Per CATAIR FDA 08-25.pdf, Table 5-23: Optional (O), Repeatable. Up to 6 levels of packaging may be described. |
pg30? | {anticipatedArrivalInfo?: "A" | "F";arrivalDate?: Date;arrivalTime?: string;inspectionOrArrivalLocation?: string;inspectionOrArrivalLocationCode?: string;}[] | Array of anticipated arrival entries. Per CATAIR FDA 08-25.pdf, Table 5-27: Mandatory (M), Repeatable. At least one entry with status "A" (Anticipated Arrival) is required with date, time, and location. A second entry with status "F" (Foreign Trade Zone) is required for Entry Type 21 from FTZ. |
pgaLineValue? | number | PGA Line Value — the value of the product for this PGA line. Per CATAIR FDA 08-25.pdf, Table 5-22: Optional (O), 12N. If transmitted, must be on the first PG25 record. |
pointOfContactEntity? | EntityReference | Point of Contact / Filer/Broker (role code: PK). Optional for BIO per Table 5-14. Submitted as a PG21-only record (no PG19/PG20). User picks a specific individual contact. |
productCodeNumber? | string | FDA Product Code (7 characters). Industry code must be 57 for Biologics. Per CATAIR FDA 08-25.pdf, Table 5-5 and Table 5-6: positions 10-28, Mandatory (M). itemType ("P") and productCodeQualifier ("FDP") are hardcoded by encoder. |
productDescription? | string | Product description providing the common/usual/market name. Per CATAIR FDA 08-25.pdf, Table 5-10: Mandatory (M), Not Repeatable. Up to 57 characters per line. See Appendix A for detailed guidance. |
remarksText? | string | Free-form remarks text. remarksTypeCode is always "GEN" and hardcoded by encoder. Per CATAIR FDA 08-25.pdf, Table 5-21: Optional (O), Not Repeatable. Up to 100 characters. |
shipperEntity? | EntityReference | Shipper (role code: DEQ). Mandatory for BIO per Table 5-11. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. |
temperatureQualifier? | "A" | "D" | "R" | "P" | "F" | "H" | "U" | Temperature qualifier for quality control or preservation purposes. Per CATAIR FDA 08-25.pdf, Table 5-22: Optional (O). A=Ambient, F=Frozen, D=Dry Ice, R=Refrigerated/Chilled, H=Fresh, U=Uncontrolled, P=Flashpoint. |