HLS 13RS-982 ENGROSSED Page 1 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. Regular Session, 2013 HOUSE BILL NO. 391 BY REPRESENTATIVE LEBAS Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana. PHARMACISTS: Clarifies powers and duties of the Louisiana Board of Pharmacy relative to nonresident pharmacists AN ACT1 To amend and reenact R.S. 37:1232 and to enact R.S. 37:1182(B)(9), relative to the2 Louisiana Board of Pharmacy; to add to the board's powers and duties with respect3 to nonresident licensees; to provide relative to nonresident pharmacies; and to4 provide for related matters.5 Be it enacted by the Legislature of Louisiana:6 Section 1. R.S. 37:1232 is hereby amended and reenacted and R.S. 37:1182(B)(9)7 is hereby enacted to read as follows: 8 §1182. Powers and duties of the board9 * * *10 B. The board may:11 * * *12 (9) Assess and collect expenses incurred for the inspection of nonresident13 licensees.14 * * *15 §1232. Out-of-state Nonresident pharmacy16 A. A pharmacy located outside this state which does business in this state17 within the meaning of this Chapter shall hold a current pharmacy permit as provided18 in this Chapter. The pharmacy shall be designated an "out-of-state a "nonresident19 HLS 13RS-982 ENGROSSED HB NO. 391 Page 2 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. pharmacy" and the permit shall be designated an "out-of-state a "nonresident1 pharmacy permit".2 B. An out-of-state A nonresident pharmacy granted an out-of-state a3 nonresident pharmacy permit by the board shall disclose to the board the location,4 names, and titles of all principal corporate officers, as well as the owner's managing5 officer and pharmacist-in-charge. A report containing this information shall be made6 to the board on an annual basis and within thirty business days after any change of7 office, corporate officer, or within ten business days of the departure of the prior8 owner's managing officer or pharmacist-in-charge.9 C. The out-of-state nonresident pharmacy shall maintain at all times10 authorization to conduct the pharmacy in compliance with the laws of the state in11 which it is a resident. As a prerequisite to seeking a permit from the board, the out-12 of-state nonresident pharmacy shall submit a copy of the most recent inspection13 report resulting from an inspection conducted by the regulatory or licensing agency14 of the state in which it is located, as well as any other state pharmacy licensing15 agency or any agent thereof, and any inspection reports produced by the federal Food16 and Drug Administration or the federal Drug Enforcement Administration.17 Thereafter, the out-of-state nonresident pharmacy granted a permit shall submit to18 the board a copy of any subsequent inspection report on the pharmacy conducted by19 the regulatory or licensing body of the state in which it is located , or by any other20 state pharmacy licensing agency, or any agent thereof, or by the federal Food and21 Drug Administration or the federal Drug Enforcement Administration. In addition22 to or in lieu of an inspection by the regulatory or licensing body of the state in which23 it is resident, or any agent thereof, the nonresident pharmacy shall be subject to an24 inspection by the board. When the board conducts an inspection of a nonresident25 pharmacy, the board shall recover its expenses from the nonresident pharmacy in26 addition to the applicable permit fee authorized by this Chapter.27 D. An out-of-state A nonresident pharmacy granted an out-of-state a28 nonresident pharmacy permit by the board shall maintain records of any controlled29 HLS 13RS-982 ENGROSSED HB NO. 391 Page 3 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. substances or dangerous drugs or devices dispensed to patients in this state so that1 the records are readily retrievable from the records of other drugs dispensed.2 E. Records for all prescriptions and products delivered into the state shall be3 readily retrievable from the other prescription records of the out-of-state nonresident4 pharmacy and shall be in compliance with all federal laws and with regulations as5 may be required by this state.6 DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] LeBas HB No. 391 Abstract: Clarifies powers of the La. Board of Pharmacy relative to nonresident pharmacists. Present law provides for the creation of the La. Board of Pharmacy (the board) within the Dept. of Health and Hospitals. Present law provides for the board to consist of 17 members appointed by the governor; further, present law lists powers and duties to be held by the board. Proposed law adds to the list of the powers set forth by present law, authorizing the board to assess and collect expenses incurred for the inspection of nonresident licensees. Present law classifies pharmacies located outside of this state as "out-of-state pharmacies". Proposed law changes the term to "nonresident pharmacists". Present law requires an out-of-state pharmacy to which the board has granted an out-of-state pharmacy permit to disclose to the board the location, names, and titles of all principal corporate officers of the out-of-state pharmacy. Proposed law retains present law and adds that the nonresident pharmacy must also disclose the location, names, and titles of the nonresident pharmacy owner's managing officer and pharmacist-in-charge. Present law requires a report containing this information to be made to the board on an annual basis and within 30 days after any change of office, corporate officer, or within 10 days of the departure of the prior pharmacist-in-charge. Proposed law requires a report containing this information to be made to the board on an annual basis and within 30 business days after any change of office, corporate officer, or within 10 business days of the departure of the prior owner's managing officer or pharmacist-in-charge. Present law requires an out-of-state pharmacy seeking an out-of-state pharmacy permit from the board to submit a copy of the most recent inspection report from any inspection conducted by the regulatory or licensing agency of the state in which it is located. HLS 13RS-982 ENGROSSED HB NO. 391 Page 4 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. Proposed law retains present law, but further requires the nonresident pharmacy to also submit any other inspection reports produced by the Food and Drug Administration or the Drug Enforcement Administration. Proposed law also requires the nonresident pharmacy to submit any reports from any other state pharmacy licensing agency who has conducted an inspection in the state in which it is located. Present law requires an out-of-state pharmacist, after the grant of an out-of-state pharmacist permit, to submit copies to the board of any subsequent inspection reports on the pharmacy which are conducted by the regulatory or licensing body of the state in which it is located. Proposed law retains present law and further requires the nonresident pharmacy, after the grant of a nonresident pharmacy permit, to also submit any other inspection reports produced by the Food and Drug Administration or the Drug Enforcement Administration. Proposed law provides that in addition to, or in lieu of, any inspections conducted by the regulatory or licensing body of the state in which it is a resident, upon the board's grant of a nonresident permit the nonresident pharmacy shall become subject to inspections by the board. Proposed law provides that the expense of such inspection shall be attributed to the nonresident pharmacy. (Amends R.S. 37:1232; Adds R.S. 37:1182(B)(9)) Summary of Amendments Adopted by House Committee Amendments Proposed by House Committee on Health and Welfare to the original bill. 1. Required a report containing a change of information to be made to the board within 30 business days after any change of office, corporate officer, or within 10 business days of the departure of the prior owner's managing officer or pharmacist-in-charge.