# WAC 182-51-0700: WAC 182-51-0700. Manufacturers — Notice of new drug applications and biologic license applications

> Washington · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0700

## Section

- **Citation:** WAC 182-51-0700
- **Heading:** WAC 182-51-0700. Manufacturers — Notice of new drug applications and biologic license applications
- **Jurisdiction:** Washington
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Washington Administrative Code / Title 182 / Chapter 182-51 / Section 182-51-0700

## Text

(1) On or before December 31, 2020, a manufacturer must submit to the authority all data specified in RCW 43.71C.060 (1), following the guidelines set in the authority's applicable data submission guide for all new drug applications or biologic license applications for pipeline drugs submitted on or after October 1, 2019, through October 15, 2020, for which the manufacturer has received an FDA approval date.
(2) Beginning October 16, 2020, a manufacturer must submit to the authority all data specified in RCW 43.71C.060 (1), following the guidelines set in the authority's applicable data submission guide for all new drug applications or biologic license applications for pipeline drugs submitted on or after October 16, 2020, within sixty calendar days of the manufacturer receiving the FDA approval date.
(3) The authority considers fifty thousand dollars per biennium to be a significant impact on state expenditures. Reporting entities may anticipate a request for additional information per RCW 43.71C.060 (3) from the authority for products expected to exceed fifty thousand dollars per biennium. To improve efficiency in reporting, manufacturers who submit a new drug application or a biologics license application for a pipeline drug or a biologics license application for a biological product that is expected to cost the state more than fifty thousand dollars per biennium may submit the data elements in RCW 43.71C.060 (3) at the same time they submit the notice of the new drug application.
(4) A manufacturer may limit the information reported according to this section to information that is in the public domain or publicly reported.
(5) The agency may assess fines for not complying with the requirements in this section. See WAC 182-51-1100 .

## Nearby sections

- [WAC 182-51-0050 WAC 182-51-0050. Authority and purpose](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0050.md)
- [WAC 182-51-0100 WAC 182-51-0100. Definitions](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0100.md)
- [WAC 182-51-0200 WAC 182-51-0200. Reporting entity registration](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0200.md)
- [WAC 182-51-0300 WAC 182-51-0300. Health carriers — Cost utilization data reporting](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0300.md)
- [WAC 182-51-0400 WAC 182-51-0400. Pharmacy benefit managers — Data reporting](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0400.md)
- [WAC 182-51-0500 WAC 182-51-0500. Pharmacy benefit managers — Compliance](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0500.md)
- [WAC 182-51-0600 WAC 182-51-0600. Manufacturers — Data and price reporting](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0600.md)
- [WAC 182-51-0700 WAC 182-51-0700. Manufacturers — Notice of new drug applications and biologic license applications](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0700.md)
- [WAC 182-51-0800 WAC 182-51-0800. Pharmacy services administrative organizations — Data reporting](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0800.md)
- [WAC 182-51-0900 WAC 182-51-0900. Data confidentiality](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0900.md)
- [WAC 182-51-1000 WAC 182-51-1000. Data submission guides](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_1000.md)
- [WAC 182-51-1100 WAC 182-51-1100. Authority to assess fines](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_1100.md)
- [WAC 182-51-1200 WAC 182-51-1200. Extension of deadlines](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_1200.md)
- [WAC 182-51-1300 WAC 182-51-1300. Fines for failure to comply with reporting requirements](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_1300.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_182_51_0700. Check the current official text before relying on it. Not legal advice.