Amendment CSA1-SB40

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.

SB40-CSA1,1371,3 (b) The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons.

SB40-CSA1,1371,5 (c) The distribution of prescription drug samples, if the distribution is permitted under 21 CFR 353 (d).

SB40-CSA1,1371,7 (d) Drug returns, when conducted by a hospital, health care entity, or charitable institution as provided in 21 CFR 203.23.

SB40-CSA1,1371,10 (e) The sale of minimal quantities, as defined by the board in an administrative rule, of prescription drugs by retail pharmacies to licensed practitioners for office use.

SB40-CSA1,1371,12 (f) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription.

SB40-CSA1,1371,15 (g) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy from or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets.

SB40-CSA1,1371,21 (h) The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record, if the manufacturer states in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the drug and the supplying authorized distributor of record states in writing that the drug has previously been exclusively in the normal distribution channel.

SB40-CSA1,1371,25 (i) The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the drug.

SB40-CSA1,1372,2 (j) A transaction excluded from the definition of "wholesale distribution" under 21 CFR 203.3 (cc).

SB40-CSA1,1372,3 (k) The donation or distribution of a prescription drug under s. 255.056.

SB40-CSA1,1372,7 (L) The transfer from a retail pharmacy or pharmacy warehouse of an expired, damaged, returned, or recalled prescription drug to the original manufacturer or original wholesale distributor or to a 3rd-party returns processor or reverse distributor.

SB40-CSA1,1372,9 (m) The return of a prescription drug, if the return is authorized by the law of this state.

SB40-CSA1, s. 3526p Section 3526p. 450.01 (24) of the statutes is created to read:

SB40-CSA1,1372,18 450.01 (24) "Wholesale distributor" means a person engaged in the wholesale distribution of prescription drugs, including manufacturers, repackagers, own-label distributors, private label distributors, jobbers, brokers, warehouses, including manufacturers' and distributors' warehouses, manufacturers' exclusive distributors, manufacturers' authorized distributors of record, prescription drug wholesalers and distributors, independent wholesale prescription drug traders, 3rd party logistics providers, retail pharmacies that conduct wholesale distribution, and chain pharmacy warehouses that conduct wholesale distribution.

SB40-CSA1, s. 3527 Section 3527. 450.06 (2) (c) of the statutes is amended to read:

SB40-CSA1,1372,21 450.06 (2) (c) The initial credential fee under s. 440.05 (1) determined by the department under s. 440.03 (9) (a) is paid.

SB40-CSA1, s. 3528 Section 3528. 450.065 (2) (d) of the statutes is amended to read:

SB40-CSA1,1372,24 450.065 (2) (d) Pays the initial credential fee under s. 440.05 (1) determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3530a Section 3530a. 450.07 (title) of the statutes is amended to read:

SB40-CSA1,1373,1 450.07 (title) Manufacturers and distributors; licensure.

SB40-CSA1, s. 3530at Section 3530at. 450.07 (1) of the statutes is amended to read:

SB40-CSA1,1373,6 450.07 (1) No person may engage in manufacturing in this state unless the person obtains a manufacturer's license from the board. For the issuance of a license under this subsection, the applicant shall pay the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a).

SB40-CSA1, s. 3530b Section 3530b. 450.07 (2) of the statutes is repealed.

SB40-CSA1, s. 3530c Section 3530c. 450.07 (3) of the statutes is repealed.

SB40-CSA1, s. 3530d Section 3530d. 450.07 (4) (c) of the statutes is created to read:

SB40-CSA1,1373,12 450.07 (4) (c) The rules adopted by the board under par. (b) shall require a manufacturer to maintain and to update at least once per month a list of the manufacturer's authorized distributors of record.

SB40-CSA1, s. 3530e Section 3530e. 450.071 of the statutes is created to read:

SB40-CSA1,1373,21 450.071 Wholesale distributors; licensure. (1) No person may engage in the wholesale distribution of a prescription drug in this state without obtaining a license from the board for each facility from which the person distributes prescription drugs. The board shall exempt a manufacturer that distributes prescription drugs or devises manufactured by the manufacturer from licensing and other requirements under this section to the extent the license or requirement is not required under federal law or regulation, unless the board determines that it is necessary to apply a requirement to a manufacturer.

SB40-CSA1,1373,23 (2) An applicant shall submit a form provided by the board showing all of the following and swear or affirm the truthfulness of each item in the application:

SB40-CSA1,1373,24 (a) The name, business address, and telephone number of the applicant.

SB40-CSA1,1373,25 (b) All trade or business names used by the applicant.

SB40-CSA1,1374,3 (c) Names, addresses, and telephone numbers of contact persons for all facilities used by the applicant for the storage, handling, and distribution of prescription drugs.

SB40-CSA1,1374,4 (d) The type of ownership or operation for the applicant's business.

SB40-CSA1,1374,6 (e) If the applicant's wholesale distribution business is a partnership, the name of each partner and the name of the partnership.

SB40-CSA1,1374,9 (f) If the applicant's wholesale distribution business is a corporation, the name of each corporate officer and director, the name of the corporation, and the state of incorporation.

SB40-CSA1,1374,11 (g) If the applicant's wholesale distribution business is a sole proprietorship, the name of the sole proprietor and the name of the business entity.

SB40-CSA1,1374,13 (h) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.

SB40-CSA1,1374,14 (i) The name, address, and telephone number of a designated representative.

SB40-CSA1,1374,16 (j) For the person listed in par. (i), a personal information statement that contains all of the following:

SB40-CSA1,1374,17 1. The person's date and place of birth.

SB40-CSA1,1374,19 2. The person's places of residence for the 7-year period immediately preceding the date of the application.

SB40-CSA1,1374,21 3. The person's occupations, positions of employment, and offices held during the 7-year period immediately preceding the date of the application.

SB40-CSA1,1374,23 4. The name and addresses for each business, corporation, or other entity listed in subd. 3.

SB40-CSA1,1375,2 5. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, the subject of any proceeding for the revocation of any business or professional license and the disposition of the proceeding.

SB40-CSA1,1375,7 6. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, enjoined by a court, either temporarily or permanently, from possessing, controlling, or distributing any prescription drug, and a description of the circumstances surrounding the injunction.

SB40-CSA1,1375,12 7. A description of any involvement by the person during the past 7 years with any business, including investments other than the ownership of stock in a publicly traded company or mutual fund, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products or drugs, and a list of any lawsuits in which such a business was named as a party.

SB40-CSA1,1375,18 8. A description of any misdemeanor or felony criminal offense of which the person was, as an adult, found guilty, whether adjudication of guilt was withheld or the person pleaded guilty or no contest. If the person is appealing a criminal conviction, the application shall include a copy of the notice of appeal, and the applicant shall submit a copy of the final disposition of the appeal not more than 15 days after a final disposition is reached.