# KRS § 315.036: 315.036 Permit to be acquired by manufacturer -- Fee -- Records required -- Report -- Exception

> Kentucky · Statutes · In force

URL: https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.036

## Section

- **Citation:** KRS § 315.036
- **Heading:** 315.036 Permit to be acquired by manufacturer -- Fee -- Records required -- Report -- Exception
- **Jurisdiction:** Kentucky
- **Kind:** Statutes
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** KY Code / Title XXVI / Chapter 315 / Section 315.036

## Text

315.036 Permit to be acquired by manufacturer -- Fee -- Records required --

Report -- Exception.

(1) Except as provided in subsection (4) of this section, each manufacturer of drugs

shall be required to register with and obtain a permit from the board. Such permit

shall be issued in accordance with policy and procedure prescribed by regulations of

the board. Each application shall be accompanied by a reasonable permit fee to be

set by administrative regulation of the board, not to exceed two hundred fifty dollars

($250) annually or increase more than twenty-five dollars ($25) per year.

(2) Manufacturers shall be required to maintain accurate records of all drugs

manufactured, received and sold, as established by administrative regulation of the

board. Such records shall be made available to agents of the board for inspection at

reasonable times. The board may require by regulation that manufacturers

periodically report to the board all drugs manufactured, received, and sold.

(3) Failure to report to the board or willful submission of inaccurate information shall

be grounds for disciplinary action under the provisions of KRS 315.131.

(4) The provisions of subsection (1) of this section do not apply to a pharmacist who, in

the normal course of professional practice, compounds reasonable quantities of

drugs pursuant to or in anticipation of a valid prescription drug order.

## Nearby sections

- [KRS § 315.002 315.002 Declarations of public policy -- Construction of chapter](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.002.md)
- [KRS § 315.005 315.005 Purpose of chapter](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.005.md)
- [KRS § 315.010 315.010 Definitions for chapter](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.010.md)
- [KRS § 315.020 315.020 Only pharmacists to supervise manufacturing of pharmaceuticals or practice pharmacy -- Exceptions -- Access to pharmacy electronic database allowed under specific conditions -- Persons employed to assist practice of pharmacy after April 1, 2009, to be registered pharmacy technicians or exempt under KRS 315.135](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.020.md)
- [KRS § 315.030 315.030 Permit required -- License required to represent oneself as pharmacist -- Registration required to represent oneself as pharmacy technician](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.030.md)
- [KRS § 315.035 315.035 Permit required for operation of a pharmacy -- Application -- Fee -- Issuance -- Fee for failure to renew -- Premises covered by permit -- Rules and regulations -- Requirements for in-state pharmacy doing business through the Internet -- Board may waive permit requirements for out-of-state pharmacy -- Temporary operation of pharmacy during state of emergency](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.035.md)
- [KRS § 315.036 315.036 Permit to be acquired by manufacturer -- Fee -- Records required -- Report -- Exception](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.036.md)
- [KRS § 315.038 315.038 Definitions for section -- Ambulatory pharmacies -- Reporting requirements -- Data to be shared with commissioner of insurance -- Contract with third-party to collect or process data](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.038.md)
- [KRS § 315.040 315.040 Exceptions to chapter](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.040.md)
- [KRS § 315.050 315.050 Qualifications of applicant for licensure -- Examination -- Standards for internship -- Certificate of internship](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.050.md)
- [KRS § 315.060 315.060 Examination fee](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.060.md)
- [KRS § 315.065 315.065 Continuing education requirements](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.065.md)
- [KRS § 315.110 315.110 License expiration date -- Renewal fee -- Application and requirements -- Certificate -- Display -- Pocket certificate](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.110.md)
- [KRS § 315.115 315.115 Renewal fees suspended for persons in Armed Forces](https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.115.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_KY_TXXVI_C315_S315.036. Check the current official text before relying on it. Not legal advice.