Amendment CSA1-SB40

SB40-CSA1,1360,16 442.09 Fees. The fees for examination and licenses granted or renewed under this chapter are specified in ss. s. 440.05 and 440.08. The fee for renewal of such licenses is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3508 Section 3508. 443.07 (6) of the statutes is amended to read:

SB40-CSA1,1360,20 443.07 (6) The renewal date and renewal fee for permits under this section are is specified under s. 440.08 (2) (a), and the fee for renewal of such permits is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3509 Section 3509. 443.08 (3) (a) of the statutes is amended to read:

SB40-CSA1,1361,11 443.08 (3) (a) A firm, partnership or corporation desiring a certificate of authorization shall submit an application to the department on forms provided by the department, listing the names and addresses of all officers and directors, and all individuals in its employment registered or granted a permit to practice architecture, professional engineering or designing in this state who will be in responsible charge of architecture, professional engineering or designing being practiced in this state through the firm, partnership or corporation and other relevant information required by the examining board. A similar type of form shall also accompany the renewal fee. If there is a change in any of these persons, the change shall be reported on the same type of form, and filed with the department within 30 days after the effective date of the change. The examining board shall grant a certificate of authorization to a firm, partnership or corporation complying with this subsection upon payment of the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a). This subsection does not apply to firms, partnerships or corporations exempt under s. 443.14 (3) or (5).

SB40-CSA1, s. 3510 Section 3510. 443.08 (3) (b) of the statutes is amended to read:

SB40-CSA1,1361,15 443.08 (3) (b) The renewal date and renewal fee for certificates of authorization under this section are is specified under s. 440.08 (2) (a), and the fee for renewal of such certificates is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3511 Section 3511. 443.10 (2) (b) of the statutes is amended to read:

SB40-CSA1,1361,19 443.10 (2) (b) The fees for examinations and licenses granted or renewed under this chapter are specified in ss. s. 440.05 and 440.08, and the fee for renewal of such licenses is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3512 Section 3512. 443.10 (2) (e) of the statutes is amended to read:

SB40-CSA1,1361,24 443.10 (2) (e) The renewal date and renewal fee for certificates of registration for architects, landscape architects, and professional engineers are is specified under s. 440.08 (2) (a), and the fee for renewal of such certificates is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3513 Section 3513. 443.10 (5) of the statutes is amended to read:

SB40-CSA1,1362,5 443.10 (5) Fees; renewals. The land surveyor's section shall grant a certificate of registration as a land surveyor to any applicant who has met the applicable requirements of this chapter. The renewal date and renewal fee for the certificate are is specified under s. 440.08 (2) (a), and the renewal fee for the certificate is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3514 Section 3514. 445.04 (2) of the statutes is amended to read:

SB40-CSA1,1362,18 445.04 (2) No person may engage in the business of a funeral director, or make a representation as engaged in such business, in whole or in part, unless first licensed as a funeral director by the examining board. Application for a license, other than a renewal, shall be in writing and verified on a form to be furnished by the department. The application must specify the address at which the applicant proposes to conduct the business of a funeral director and shall contain such other information as the examining board requires to determine compliance with the requirements of this chapter. Accompanying the application shall be the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a), together with affidavits of recommendation from at least 2 persons of the county in which the applicant resides or proposes to conduct the business of a funeral director.

SB40-CSA1, s. 3515 Section 3515. 445.06 of the statutes is amended to read:

SB40-CSA1,1363,9 445.06 Renewal of licenses. The renewal date and renewal fee for a funeral directors' license are is specified under s. 440.08 (2) (a), and the renewal fee for such license is determined by the department under s. 440.03 (9) (a). Before any renewal license is delivered to any licensed funeral director, proof must be furnished by the applicant, to the satisfaction of the examining board, that the applicant is doing business at a recognized funeral establishment, except that if such applicant is not doing business at a recognized funeral establishment at the time of application for a license, the applicant shall be given a certificate, without additional cost, to the effect that the applicant is in good standing as a funeral director, and shall be entitled to a renewal license at any time during that license period, when located at a recognized funeral establishment, without payment of any additional renewal fee. The applicant must also furnish proof of completion of at least 15 hours of continuing education during the previous 2-year licensure period, except that new licensees are exempt from this requirement during the time between initial licensure and commencement of a full 2-year licensure period.

SB40-CSA1, s. 3516 Section 3516. 445.105 (3) of the statutes is amended to read:

SB40-CSA1,1363,16 445.105 (3) Applications for funeral establishment permits shall be made on forms provided by the department and filed with the department and shall be accompanied by the initial credential fee specified under s. 440.05 (1) determined by the department under s. 440.03 (9) (a). The renewal date and renewal fee for a funeral establishment permit are is specified under s. 440.08 (2) (a), and the renewal fee for such permit is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3517 Section 3517. 446.02 (4) of the statutes is amended to read:

SB40-CSA1,1363,20 446.02 (4) The renewal date and renewal fee for all licenses granted by the examining board are is specified under s. 440.08 (2) (a), and the renewal fee for such licenses is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3518 Section 3518. 447.05 of the statutes is amended to read:

SB40-CSA1,1364,4 447.05 Expiration and renewal. Renewal applications shall be submitted to the department on a form provided by the department on or before the applicable renewal date specified under s. 440.08 (2) (a) and shall include the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a). The examining board may not renew a license to practice dental hygiene unless the applicant for renewal attests that he or she has complied with s. 447.055 and any rules promulgated by the department under s. 447.055 and that he or she has a current certification in cardiopulmonary resuscitation.

SB40-CSA1, s. 3519 Section 3519. 448.07 (2) of the statutes is amended to read:

SB40-CSA1,1364,8 448.07 (2) Fees. The fees for examination and licenses granted or renewed under this subchapter are specified in ss. s. 440.05, and 440.08 the renewal fee for such licenses is determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3520 Section 3520. 448.55 (2) of the statutes is amended to read:

SB40-CSA1,1364,16 448.55 (2) The renewal dates for licenses granted under this subchapter, other than temporary licenses granted under rules promulgated under s. 448.53 (2), are specified under s. 440.08 (2) (a). Renewal applications shall be submitted to the department on a form provided by the department and shall include the renewal fee specified in s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) and proof of compliance with the requirements established in any rules promulgated under sub. (3).

SB40-CSA1, s. 3521 Section 3521. 448.65 (2) (a) of the statutes is amended to read:

SB40-CSA1,1364,19 448.65 (2) (a) The renewal fee specified in s. 440.08 (2) (a) determined by the department under 440.03 (9) (a).

SB40-CSA1, s. 3522 Section 3522. 448.86 (2) of the statutes is amended to read:

SB40-CSA1,1364,25 448.86 (2) The renewal dates for certificates granted under this subchapter, other than temporary certificates granted under s. 448.80, are specified under s. 440.08 (2) (a). Renewal applications shall be submitted to the department on a form provided by the department and shall include the renewal fee specified in s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3523 Section 3523. 448.955 (2) (intro.) of the statutes is amended to read:

SB40-CSA1,1365,6 448.955 (2) (intro.) Renewal applications shall be submitted to the department on a form provided, subject to sub. (3), by the department and shall include the renewal fee specified in s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) and evidence satisfactory to the affiliated credentialing board that the licensee has all of the following:

SB40-CSA1, s. 3524 Section 3524. 448.967 (2) of the statutes is amended to read:

SB40-CSA1,1365,13 448.967 (2) The renewal dates for licenses granted under this subchapter are specified under s. 440.08 (2) (a). Renewal applications shall be submitted to the department on a form provided by the department and shall include the renewal fee specified in s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) and a statement attesting compliance with the continuing education requirements established in rules promulgated under s. 448.965 (1) (b).

SB40-CSA1, s. 3525 Section 3525. 449.06 (1) of the statutes is amended to read:

SB40-CSA1,1365,19 449.06 (1) Persons practicing optometry shall, on or before the applicable renewal date specified under s. 440.08 (2) (a), register with the department, pay the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a), and provide evidence satisfactory to the examining board that he or she has complied with the rules promulgated under sub. (2m).

SB40-CSA1, s. 3526 Section 3526. 449.17 (8) of the statutes is amended to read:

SB40-CSA1,1365,23 449.17 (8) Reimbursement prohibited. No optometrist may be reimbursed under s. 49.46 (2) (a) 3. or 49.471 (11) for any increase in charges or separate charge which is attributable to the use of topical ocular diagnostic pharmaceutical agents.

SB40-CSA1, s. 3526a Section 3526a. 450.01 (1p) of the statutes is created to read:

SB40-CSA1,1366,2 450.01 (1p) "Affiliated group" has the meaning given in section 1504 of the Internal Revenue Code.

SB40-CSA1, s. 3526b Section 3526b. 450.01 (1t) of the statutes is created to read:

SB40-CSA1,1366,6 450.01 (1t) "Authenticate" means to affirmatively verify, before wholesale distribution of a prescription drug occurs, that each transaction listed on a pedigree has occurred.

SB40-CSA1, s. 3526c Section 3526c. 450.01 (1x) of the statutes is created to read:

SB40-CSA1,1366,12 450.01 (1x) "Authorized distributor of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. For purposes of this subsection, an ongoing relationship exists between a wholesale distributor and a manufacturer if all of the following apply:

SB40-CSA1,1366,15 (a) The wholesale distributor, including any affiliated group of the wholesale distributor, has in effect a written agreement with the manufacturer evidencing the ongoing relationship.

SB40-CSA1,1366,18 (b) The wholesale distributor, including any affiliated group of the wholesale distributor, is included in the manufacturer's current list of authorized distributors of record.

SB40-CSA1, s. 3526d Section 3526d. 450.01 (2m) of the statutes is created to read:

SB40-CSA1,1366,23 450.01 (2m) "Colicensed" means, with respect to a partner or product, that 2 or more parties have the right to engage in marketing or manufacturing of a product consistent with the federal food and drug administration's implementation of the federal prescription drug marketing act.

SB40-CSA1, s. 3526e Section 3526e. 450.01 (9m) of the statutes is created to read:

SB40-CSA1,1367,4 450.01 (9m) "Drop shipment" means a sale of a prescription drug to a wholesale distributor by the manufacturer of the drug, by the manufacturer's colicensed product partner, by the manufacturer's 3rd party logistics provider, or by the manufacturer's exclusive distributor, to which all of the following apply:

SB40-CSA1,1367,6 (a) The wholesale distributor or chain pharmacy warehouse takes title to, but not physical possession of, the drug.

SB40-CSA1,1367,8 (b) The wholesale distributor invoices a pharmacy, a chain pharmacy warehouse, or a person authorized to dispense or administer the drug to a patient.

SB40-CSA1,1367,12 (c) The pharmacy, chain pharmacy warehouse, or person authorized to dispense or administer the drug receives delivery of the drug directly from the manufacturer, the manufacturer's 3rd party logistics provider, or the manufacturer's exclusive distributor.

SB40-CSA1, s. 3526f Section 3526f. 450.01 (11m) of the statutes is created to read:

SB40-CSA1,1367,15 450.01 (11m) "Facility" means a location where a wholesale distributor stores, handles, repackages, or offers for sale prescription drugs.

SB40-CSA1, s. 3526g Section 3526g. 450.01 (11r) of the statutes is created to read:

SB40-CSA1,1367,20 450.01 (11r) "Intracompany sales" means any transaction or transfer between any division, subsidiary, parent, or affiliated or related company under common ownership and control of a corporate entity or any transaction or transfer between colicensees of a colicensed product.

SB40-CSA1, s. 3526h Section 3526h. 450.01 (12) of the statutes is amended to read:

SB40-CSA1,1368,2 450.01 (12) "Manufacturer" means a person licensed by the board under s. 450.07 (1) or approved by the federal food and drug administration to engage in the manufacture of drugs or devices, consistent with the definition of "manufacturer" under the federal food and drug administration's regulations and interpreted guidances implementing the federal prescription drug marketing act.

SB40-CSA1, s. 3526i Section 3526i. 450.01 (12m) of the statutes is created to read:

SB40-CSA1,1368,8 450.01 (12m) "Manufacturer's exclusive distributor" means a person that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer and who takes title to the manufacturer's prescription drug but who does not have general responsibility to direct the sale or disposition of the drug.

SB40-CSA1, s. 3526j Section 3526j. 450.01 (13r) of the statutes is created to read:

SB40-CSA1,1368,15 450.01 (13r) (a) "Normal distribution channel" means a chain of custody for a prescription drug that runs, directly or by drop shipment, from the manufacturer of a drug, from the manufacturer to the manufacturer's colicensed partner, from the manufacturer to the manufacturer's 3rd-party logistics provider, or from the manufacturer to the manufacturer's exclusive distributor, and continues as described in any of the following:

SB40-CSA1,1368,17 1. To a pharmacy or to a person authorized to dispense or administer a drug to a patient.

SB40-CSA1,1368,19 2. To an authorized distributor of record, and then to a pharmacy or to a person authorized to dispense or administer a drug to a patient.

SB40-CSA1,1368,21 3. To an authorized distributor of record, then to one other authorized distributor of record, then to an office-based practitioner.

SB40-CSA1,1368,24 4. To a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy, then to a patient or to a person authorized to dispense or administer a drug to a patient.

SB40-CSA1,1369,3 5. To an authorized distributor of record, then to a pharmacy warehouse, then to the pharmacy warehouse's intracompany pharmacy, then to a patient or to a person authorized to dispense or administer a drug to a patient.

SB40-CSA1,1369,8 (b) For purposes of this subsection, a distribution of a prescription drug to a warehouse or to another entity that redistributes the drug by intracompany sale to a pharmacy or to another person authorized to dispense or administer the drug constitutes a distribution to the pharmacy or to the person authorized to dispense or administer the drug.

SB40-CSA1, s. 3526k Section 3526k. 450.01 (14m) of the statutes is created to read:

SB40-CSA1,1369,11 450.01 (14m) "Pedigree" means a document or electronic file containing information that records each distribution of a prescription drug.

SB40-CSA1, s. 3526km Section 3526km. 450.01 (15m) of the statutes is created to read:

SB40-CSA1,1369,15 450.01 (15m) "Pharmacy warehouse" means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales.

SB40-CSA1, s. 3526kr Section 3526kr. 450.01 (20) of the statutes is amended to read:

SB40-CSA1,1369,19 450.01 (20) "Prescription drug" means all of the following, but does not include blood, blood components intended for transfusion, or biological products that are also medical devices:

SB40-CSA1,1369,21 (a) Any A drug, drug product, or drug-containing preparation which that is subject to 21 USC 353 (b) or 21 CFR 201.105.

SB40-CSA1,1370,2 (b) Any A controlled substance included in schedules II to V of ch. 961, whether by statute or rule, except substances which a substance that by law may be dispensed without the prescription order of a practitioner. Controlled substances are included within this definition for purposes of s. 450.11 (3), (4) (a), and (8) only and for violations thereof punishable under s. 450.11 (9).

SB40-CSA1, s. 3526L Section 3526L. 450.01 (21e) of the statutes is created to read:

SB40-CSA1,1370,6 450.01 (21e) "Repackage" means to repack or otherwise change the container, wrapper, or label of a prescription drug, except that "repackage" does not include any of the following:

SB40-CSA1,1370,8 (a) An action by a pharmacist with respect to a prescription drug that the pharmacist is dispensing.

SB40-CSA1,1370,12 (b) An action by a pharmacist who receives a prescription drug or device that the pharmacist dispensed to a patient, if, after altering the packaging or labeling of the prescription drug or device, the pharmacist returns the prescription drug or device to the patient.

SB40-CSA1, s. 3526m Section 3526m. 450.01 (21m) of the statutes is created to read:

SB40-CSA1,1370,14 450.01 (21m) "Repackager" means a person that repackages.

SB40-CSA1, s. 3526n Section 3526n. 450.01 (21s) of the statutes is created to read:

SB40-CSA1,1370,20 450.01 (21s) "Third party logistics provider" means a person that contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer but that does not take title to the manufacturer's prescription drug or have general responsibility to direct the prescription drug's sale or disposition.

SB40-CSA1, s. 3526o Section 3526o. 450.01 (23) of the statutes is created to read:

SB40-CSA1,1370,24 450.01 (23) "Wholesale distribution" means distribution of a prescription drug to a person other than a consumer or patient, but does not include any of the following:

SB40-CSA1,1370,25 (a) Intracompany sales of prescription drugs.