Report Title:
Pharmacy; Unannounced Inspections
Description:
Requires the board of pharmacy to conduct unannounced site inspections of pharmacies at least once during the period that a pharmacy permit is in force. Makes acceptance of on-site inspections a condition of receiving a permit to operate a pharmacy.
|
HOUSE OF REPRESENTATIVES |
H.B. NO. |
636 |
|
TWENTY-FIFTH LEGISLATURE, 2009 |
|
|
|
STATE OF HAWAII |
|
|
|
|
|
|
|
|
||
|
|
||
A BILL FOR AN ACT
RELATING TO BOARD OF PHARMACY.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
SECTION 1. Section 461-4.5, Hawaii Revised Statutes, is amended by amending subsection (a) to read as follows:
"(a) In addition to any other powers and duties authorized by law, the board:
(1) Shall adopt, amend, and repeal rules pursuant to chapter 91, as it deems proper for the purposes of this chapter, Public Law 100-293, and 21 Code of Federal Regulations part 205;
(2) Shall examine, license, reinstate, and renew the licenses of qualified applicants for registered pharmacists and wholesale prescription drug distributors, and issue and renew permits to operate pharmacies;
(3) May require the inspection of any wholesale
prescription drug distributor premises in the State to ensure compliance with
this chapter and rules adopted under this chapter, or may require an applicant
for a pharmacy license to submit a statement that the premises, including but
not limited to security and sanitation, are in conformance with the board's
requirements and that the applicant possesses the reference materials and
technical clinical equipment and supplies as may be specified in rules adopted
under this chapter; [and]
(4) May fine, suspend, or revoke any license or
permit for any cause prescribed by this chapter, or for any violation of the
rules adopted under this chapter, and refuse to grant or renew any license or
permit for any cause which would be ground for revocation or suspension of a
license or permit[.]; and
(5) Shall conduct an unannounced on-site inspection of each pharmacy operating under a permit under section 461-14 at least once during the period the permit is in effect to ensure compliance with this chapter and the rules adopted thereunder."
SECTION 2. Section 461-14, Hawaii Revised Statutes, is amended by amending subsection (c) to read as follows:
"(c) On evidence satisfactory to the board, a permit or notification shall be issued; provided that:
(1) The pharmacy for which the permit or notification is sought is or will be in full compliance with this chapter and rules of the board;
(2) The location and appointments of the pharmacy are
such that it can be operated and maintained without endangering the public
health or safety; [and]
(3) The pharmacy will be under the personal and
immediate supervision of a registered pharmacist[.]; and
(4) The pharmacy shall allow unannounced on-site inspections by the board pursuant to section 461-4.5(a)(5)."
SECTION 3. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.
SECTION 4. This Act shall take effect upon its approval.
|
INTRODUCED BY: |
_____________________________ |
|
|
|