(2) A pedigree shall contain all necessary identifying information concerning each sale in the chain of the distribution of the prescription drug from the manufacturer of the prescription drug or the manufacturers 3rd-party logistics provider, colicensed product partner, or exclusive distributor until final sale or distribution to a pharmacy or a person dispensing or distributing the prescription drug. The pedigree shall include all of the following:
(a) The name, address, telephone number, and, if available, electronic mail address of each recipient or distributor of the prescription drug in the chain of distribution, until the final sale or distribution described in sub. (2) (intro.).
(b) The name and address of each facility from which the prescription drug was distributed, if different from the address provided in par. (a).
(c) The date of each distribution.
(d) A certification that every recipient has authenticated the pedigree before distribution of the prescription drug to the next point in the chain of distribution.
(e) The name, dosage strength, size and number of containers, lot number, and name of the manufacturer for each prescription drug.
(3) The board shall promulgate rules implementing an electronic track and trace pedigree system. Not later than July 1, 2010, the board shall determine the date on which the system will be implemented. The system may not be implemented before July 1, 2011, and the board may delay the implementation date in increments if the board determines that the technology to implement the system is not yet universally available across the prescription drug supply chain or is not capable of adequately protecting patient safety.
(4) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager but not including the original manufacturer of the prescription drug, who possesses a pedigree for the prescription drug, and who intends to further distribute the prescription drug, shall verify that each transaction recorded on the pedigree has occurred before the person may distribute the prescription drug.
(5) (a) A pedigree shall be maintained by a person who purchases prescription drugs identified in the pedigree and by a wholesale distributor who distributes prescription drugs identified in the pedigree for not less than 3 years from the date of sale or distribution.
(b) A person maintaining a pedigree under par. (a) shall make the pedigree available for inspection or use by a law enforcement officer within 7 days after the law enforcement officer's request.
20,3530i Section 3530i. 450.074 of the statutes is created to read:
450.074 Wholesale distributors; prohibited actions, enforcement, penalties. (1) If the board finds that there is a reasonable probability that a wholesale distributor, other than a manufacturer, has done any of the following, that continued distribution of a prescription drug involved in the occurrence could cause death or serious adverse health consequences, and that additional procedures would result in an unreasonable delay, the board shall issue an order requiring that distribution of a prescription drug in this state cease immediately:
(a) Violated a provision of ss. 450.071 to 450.073.
(b) Falsified a pedigree or sold, distributed, transferred, manufactured, repackaged, handled, or held a counterfeit prescription drug intended for human use.
(2) If the board issues an order under sub. (1), the board shall provide the person who is the subject of the order an opportunity for an informal hearing not more than 10 days after the date on which the order is issued. If, after a hearing, the board determines that the order was issued without sufficient grounds, the board shall vacate the order.
(3) Any person who knowingly does any of the following is guilty of a Class H felony:
(a) Fails to obtain a license required under s. 450.071.
(b) Purchases or otherwise receives a prescription drug from a pharmacy in violation of s. 450.072 (1).
(c) Violates s. 450.072 (2) (a), if the person is required to obtain a license under s. 450.071.
(d) Violates s. 450.072 (2) (b).
(e) Violates s. 450.072 (2) (d).
(f) Violates s. 450.073.
(g) Provides false or fraudulent records to, or makes a false or fraudulent statement to, the board, a representative of the board, or a federal official.
(h) Obtains or attempts to obtain a prescription drug by fraud, deceit, or misrepresentation, or engages in misrepresentation or fraud in the distribution of a prescription drug.
(i) Manufactures, repackages, sells, transfers, delivers, holds, or offers for sale a prescription drug that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or otherwise unfit for distribution, except for wholesale distribution by a manufacturer of a prescription drug that has been delivered into commerce pursuant to an application approved by the federal food and drug administration.
(j) Adulterates, misbrands, or counterfeits a prescription drug, except for wholesale distribution by a manufacturer of a prescription drug that has been delivered into commerce pursuant to an application approved by the federal food and drug administration.
(k) Receives a prescription drug that has been adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeited, or suspected of being counterfeited, and delivers or proffers such a drug.
(L) Alters, mutilates, destroys, obliterates, or removes any part of the labeling of a prescription drug or commits another act that results in the misbranding of a prescription drug.
(4) Subsection (3) does not apply to a prescription drug manufacturer or an agent of a prescription drug manufacturer, if the manufacturer or agent is obtaining or attempting to obtain a prescription drug for the sole purpose of testing the authenticity of the prescription drug.
20,3531 Section 3531. 450.08 (2) (a) of the statutes is amended to read:
450.08 (2) (a) A pharmacist's license may be renewed by complying with continuing education requirements under s. 450.085 and paying the applicable fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a). Failure to obtain renewal within the time period specified under this paragraph terminates the right of the person to be licensed as a pharmacist, and such right can only be acquired by passing an examination to the satisfaction of the board.
20,3532 Section 3532. 450.08 (2) (b) of the statutes is amended to read:
450.08 (2) (b) A pharmacy, manufacturer's or distributor's license may be renewed by paying the applicable fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a).
20,3533 Section 3533. 451.04 (4) of the statutes is amended to read:
451.04 (4) 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).
20,3534 Section 3534. 452.025 (1) (c) of the statutes is amended to read:
452.025 (1) (c) Each application for registration as a time-share salesperson shall be accompanied by an initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a) or the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a), whichever is appropriate.
20,3535 Section 3535. 452.025 (5) (b) of the statutes is amended to read:
452.025 (5) (b) An application to renew a certificate of registration granted under this section shall be submitted with the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a).
20,3536 Section 3536. 452.10 (3) of the statutes is amended to read:
452.10 (3) The fees for examinations and licenses granted or renewed under this chapter are specified under ss. s. 440.05, and 440.08 the renewal fee for such licenses is determined by the department under s. 440.03 (9) (a).
20,3537 Section 3537. 452.12 (2) (c) of the statutes is amended to read:
452.12 (2) (c) Application for a business entity license shall be made on forms prescribed by the department, listing the names and addresses of all business representatives, and shall be accompanied by the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a). If there is a change in any of the business representatives, the change shall be reported to the department, on the same form, within 30 days after the effective date of the change.
20,3538 Section 3538. 452.12 (5) (a) of the statutes is amended to read:
452.12 (5) (a) Renewal applications for all licenses shall be submitted with the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a).
20,3539 Section 3539. 452.12 (6) (e) 1. of the statutes is amended to read:
452.12 (6) (e) 1. If a person has registered as an inactive licensee before November 1, 1990, the department shall reinstate the person's original license if that person applies to the department for reinstatement of his or her original license, pays the fees fee specified under s. 440.05 (1) (a) and (b), passes an examination under s. 452.09 (3) and completes the education requirements established by the department under par. (f).
20,3540 Section 3540. 452.12 (6) (e) 2. of the statutes is amended to read:
452.12 (6) (e) 2. If a person has registered as an inactive licensee on or after November 1, 1990, the department shall reinstate the person's original license if that person applies to the department for reinstatement of his or her original license, pays the renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) for the original license and completes 12 hours of continuing education as established by the department under par. (f). A person who is eligible for reinstatement of his or her original license under this subdivision shall complete the requirements for reinstatement under this subdivision before January 1, 1996, or within 5 years after the date on which the person registered as an inactive licensee, whichever is later.
20,3541 Section 3541. 453.062 (1) of the statutes is amended to read:
453.062 (1) Renewal. The renewal dates and renewal fees for veterinary licenses and veterinary technician certifications are specified under s. 440.08 (2) (a), and the renewal fees for such licenses and certifications are determined by the department under s. 440.03 (9) (a).
20,3542 Section 3542. 454.06 (1) (a) of the statutes is amended to read:
454.06 (1) (a) The applicant pays the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a), except as provided in s. 454.13 (1).
20,3543 Section 3543. 454.06 (8) of the statutes is amended to read:
454.06 (8) Expiration and renewal. The renewal date and renewal fee for licenses issued under subs. (2) to (6) are is specified under s. 440.08 (2) (a), and the renewal fees for such licenses are determined by the department under s. 440.03 (9) (a).
20,3544 Section 3544. 454.08 (3) of the statutes is amended to read:
454.08 (3) The examining board shall issue an establishment license to any person who pays the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a) and who satisfies the requirements established by the examining board by rule, including proof of ownership of the business. Any change of ownership shall be reported to the examining board by the new owner within 5 days after the change of ownership.
20,3545 Section 3545. 454.08 (9) of the statutes is amended to read:
454.08 (9) The renewal date and renewal fee for licenses issued under this section 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).
20,3546 Section 3546. 455.06 of the statutes is amended to read:
455.06 Renewals. The renewal date and renewal fee for licenses issued under s. 455.04 (1) and (4) 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). An applicant for renewal of a license shall include with his or her application proof of completion of continuing education programs or courses approved under s. 455.065 (4) for the minimum number of hours required in the rules promulgated under s. 455.065 (1).
20,3547 Section 3547. 455.07 (2) of the statutes is amended to read:
455.07 (2) The fee for renewal of a license under this chapter is specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a).
20,3548 Section 3548. 456.07 (2) of the statutes is amended to read:
456.07 (2) The application for a new certificate of registration shall include the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) and evidence satisfactory to the examining board that during the biennial period immediately preceding application for registration the applicant has attended a continuation education program or course of study. During the time between initial licensure and commencement of a full 2-year licensure period new licensees shall not be required to meet continuing education requirements. All registration fees are payable on or before the applicable renewal date specified under s. 440.08 (2) (a).
20,3549 Section 3549. 457.20 (3) (a) of the statutes is amended to read:
457.20 (3) (a) The renewal fee specified in s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a).
20,3550 Section 3550. 458.11 of the statutes is amended to read:
458.11 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). Renewal of an appraiser certificate automatically renews the individual's appraiser license without payment of the renewal fee for the appraiser license or completion of any additional continuing education requirements that would otherwise be required for renewal of the appraiser license. Renewal applications shall be accompanied by proof of completion of the continuing education requirements in s. 458.13. Notwithstanding s. 458.06 (3) (b) 2. and (4) (b) 2., 1989 stats., and s. 458.08 (3) (b) 2. and (c) 2., 1991 stats., the department may not renew a certificate that was granted under s. 458.06 (3) or (4) before May 29, 1993, unless the holder of the certificate submits evidence satisfactory to the department that he or she has successfully completed the applicable educational requirements specified in rules promulgated under s. 458.085 (1) and the department may not renew a certificate that was granted under s. 458.08 (3) before May 29, 1993, unless the holder of the certificate submits evidence satisfactory to the department that he or she has successfully completed the applicable education and experience requirements specified in rules promulgated under s. 458.085 (1) and (2).
20,3551 Section 3551. 459.09 (1) (a) of the statutes is amended to read:
459.09 (1) (a) Pay to the department the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a).
20,3552 Section 3552. 459.24 (5) (a) of the statutes is amended to read:
459.24 (5) (a) The renewal fee specified in s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a).
20,3553 Section 3553. 460.07 (2) (a) of the statutes is amended to read:
460.07 (2) (a) The renewal fee specified in s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a).
20,3554 Section 3554. 470.045 (3) (a) of the statutes is amended to read:
470.045 (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 licensed to practice professional geology, hydrology or soil science in this state who will be in responsible charge of professional geology, hydrology or soil science being practiced in this state through the firm, partnership or corporation and other relevant information required by the appropriate section of 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 appropriate section of 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. 470.025 (3).
20,3555 Section 3555. 470.045 (3) (b) of the statutes is amended to read:
470.045 (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 renewal fee for such certificates is determined by the department under s. 440.03 (9) (a).
20,3556 Section 3556. 470.07 of the statutes is amended to read:
470.07 Renewal of licenses. The renewal dates for licenses granted under this chapter 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 evidence satisfactory to the appropriate section of the examining board that the applicant has completed any continuing education requirements specified in rules promulgated under s. 470.03 (2).
20,3557 Section 3557. 480.08 (3) (b) of the statutes is amended to read:
480.08 (3) (b) Pays the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a).
20,3558 Section 3558. 480.08 (5) of the statutes is amended to read:
480.08 (5) Expiration and renewal. The renewal date and renewal fee for certificates granted under this chapter, other than temporary certificates granted under sub. (7), are is specified under s. 440.08 (2) (a), and the renewal fee for certificates granted under this chapter, other than temporary certificates granted under sub. (7), is determined by the department under s. 440.03 (9) (a). Renewal applications shall include evidence satisfactory to the department that the applicant holds a current permit issued under s. 77.52 (9). A renewal application for an auctioneer certificate shall be accompanied by proof of completion of continuing education requirements under sub. (6).
20,3559 Section 3559. 551.32 (1) (bm) 2. b. of the statutes is amended to read:
551.32 (1) (bm) 2. b. The division may disclose information under subd. 1. a. to the department of workforce development children and families in accordance with a memorandum of understanding under s. 49.857.
20,3560 Section 3560. 551.32 (1) (bs) 1. of the statutes is amended to read:
551.32 (1) (bs) 1. If an applicant for the issuance or renewal of a license under this section is an individual who does not have a social security number, the applicant, as a condition of applying for or applying to renew the license, shall submit a statement made or subscribed under oath or affirmation to the division that the applicant does not have a social security number. The form of the statement shall be prescribed by the department of workforce development children and families.
Loading...
Loading...