Senate Bill 2312 Chapter 2003-155 Laws of Florida

1. Senate Bill 2312Chapter 2003-155Laws of Florida Prescription Drug Protection Act Industry Training

2. MAJOR SUBJECT AREAS • PERMITTING • AUTHORIZED DISTRIBUTOR OF RECORD • PEDIGREE PAPERS • MISCELLANEOUS • RULE TIMELINE • INSPECTIONS & ENFORCEMENT TOOLS

3. Laws of Florida, Chapter 2003 -155 signed into law by Governor on 6/13/03

4. PERMITTING

5. PERMITTING • Accelerated Expiration Dates (22, 23, & 29) • Permittees notified (May 9, 2003 letters) • Modify expiration dates in database • One-year permit expiration / fees (7/1/03-12/31/03)

6. PERMITTING • Expires on expiration date - no longer have grace period for wholesalers. • Can continue operating on timely submitted renewal application until final disposition of application. • Mail renewal apps 90 days prior to expiration • delinquent fee required if not postmarked 45 days prior to expiration date • begin for renewals with expiration date = 1/31/2004 to be mailed early November 2003 • will use proposed new application forms

7. PERMITTING • $100,000 bond requirement - • required upon submission of new application or renewal application effective 7/1/2003 • bond form available on web site (Rule) • rule defining ‘other equivalent means of security’ effective July 1, 2003 • irrevocable letter of credit • deposit in a trust account or financial institution

8. Rule Language - In order for another means of security to satisfy the bond requirement, the security must be in a form that the applicant or permittee cannot revoke, withdraw, cancel, or otherwise reduce the department’s interest until the conditions upon which the bond can be refunded or released, as set forth in 499.012(2), have been satisfied.

9. PERMITTING • Create Application Forms - new & renewal (Rule) • Primary wholesaler (in-state and out-of-state) • Secondary wholesaler (in-state and out-of-state)

10. PERMITTING • Primary / Secondary wholesaler status (Rule)used for: • application process • membership on the Drug Wholesaler Advisory Council ***has nothing to do with pedigree papers or authorized distributor of record***

11. PERMITTING • Primary wholesaler 1.purchased at least 90% of total rx drugs ($) directly from manufacturers in the previous year and 2.a. directly purchased from at least 50 manufacturers or b. has, or the affiliated group has, at least 250 employees

12. PERMITTING • Directly from the manufacturer means: • purchases made by the wholesale distributor and • transfers from affiliated group members IF • the affiliated group purchased at least 90% of total rx drugs ($) directly from manufacturers in the previous year and • all affiliated group members are disclosed to the dept and wholesaler agrees to provide records for all the members within 48 hours of a request.

13. PERMITTING • NEW Application Forms - new & renewal (Rule) • Primary wholesaler (in-state and out-of-state) • Secondary wholesaler (in-state and out-of-state) • both require Personal Information Statement • Nonresident Prescription Drug Manufacturer • Freight Forwarder • revise other permit application forms (Prescription Drug Repackager and others) • Designated Representative

14. PERMITTING • Primary & Secondary Wholesaler - application • Name, address, telephone number (fax & email) • Type of ownership • Name & address of each affiliated group member • Estimate if new applicant & actual if renewal: • Annual $ volume of rx sales • Annual % of total sales that are rx • Annual $ volume of rx purchases • Annual $ volume of rx purchases directly from manufacturers • Renewal - total $ volume of rx sales in past 6 mths

15. PERMITTING • Primary & Secondary Wholesaler - application • Tax year of applicant • Copy of property deed or lease (term >= 1 year) • Other state’s licenses / permits to purchase rx drugs • Personal Info & Fingerprints • Manager • Next 4 highest ranking employees (resp. for rx operations) • Designated representative • All affiliated parties • Information to support primary wholesaler status • Any other relevant information

16. "Affiliated party" means: (a) A director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant; (b) A person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant; (c) A person who has filed or is required to file a personal information statement pursuant to s. 499.012(4) or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(3); or (d) The five largest natural shareholders that own at least 5 percent of the permittee or applicant.

17. PERMITTING • Secondary Wholesaler - add’l application issues • information on corporate shareholders • name, address, title of officers and directors • name & address of resident agent • state of incorporation • name & address of shareholders owning 5% or more • financial institutions for rx activity & signatories • sources & amount of funds to purchase or finance rx drugs and premises • if funds borrowed, copies of promissory notes / loans • personal information and fingerprints on affiliated parties

18. PERMITTING • Personal Information Statement • date & place of birth • for past 7 years: • occupations, employment, offices held including thebusiness name and address • party to permit / license revocation including nature and disposition of proceeding • enjoined from violating law regarding rx drugs • involvement with company which manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits related thereto

19. PERMITTING • Personal Information Statement (continued) • felony criminal offenses • photograph taken within the previous 30 days • name, address, occupation, and date and place of birth for each adult member of the person’s immediate family (spouse, children & spouses, parents, and siblings & spouses)

20. PERMITTING • Designated Representative required for new or renewal permit issued after 1/1/2004 • must be certified (provisional & final after testing eff.) • 18 years old and • > 2 years verifiable full-time work experience • in a pharmacy where responsibilities included recordkeeping for rx drugs or • managerial experience with a rx drug wholesaler • test (develop, validate, method of administration) • passing score on exam re: federal & state drug wholesale laws(Reference materials for example: Federal Food Drug and Cosmetic Act; Title 21 C.F.R. Parts 203 and 205; Chapter 499, Florida Statutes; and Rule Chapter 64F-12, Florida Administrative Code) • effective one year after results of initial exam mailed

21. PERMITTING • Designated Representative • employed full time in managerial capacity, • actively involved and aware of actual daily operation, • physically present, and • for only one wholesaler at a time • notify dept within 10 days of departure & new designated representative; else cease operations • may have more than one employee that is certified but may only have one person designated at a time.

22. PERMITTING • Freight forwarder: • a person who receives legend drugs which are owned by another person and designated by that person for export, and exports those legend drugs. • Permit required effective 1/1/2004 - will give 6 months for implementation (freight forwarders to get permitted) before begin fining - will send warning letters initially.

23. PERMITTING • Prescription Drug Repackager: • separated out from definition of manufacture • new permit for prescription drug repackagers (1/1/2004) • repackagers will be required to provide pedigree papers just like a wholesaler

24. PERMITTING • Convert Out-of-state rx drug wholesalers (manufacturers) to nonresident prescription drug manufacturers • manufacturer or distribution point for manufacturer • owned or contract distribution warehouse • private label distributors not located in Florida (originally manufactured and labeled for distributor - not repackaged drugs)

25. Private label distributors not located in Florida Non-resident rx drug mfgr Non-resident rx drug mfgr Manufacturer ANDA holder Private label distributor Wholesaler Customer

26. Private label distributors located in Florida Non-resident rx drug mfgr Manufacturer ANDA holder Rx Drug Wholesaler Private label distributor Wholesaler Customer

27. PERMITTING • Convert Out-of-state rx drug wholesalers (manufacturers) to nonresident prescription drug manufacturers • manufacturer or distribution point for manufacturer • owned or contract distribution warehouse • private label distributors not located in Florida (originally manufactured and labeled for distributor - not repackaged drugs) • entity to whom an approved NDA is issued • contract manufacturer

28. PERMITTING • Convert Out-of-state rx drug wholesalers (manufacturers) to nonresident prescription drug manufacturers (continued) • Import rx drugs (APIs) - nonresident rx manufacturer gets permit and provides list of specific drug(s) will be importing which are supported by approval from FDA - may designate agent • no longer issue OOS wholesaler permit for establishments not qualifying as “a state” • may be required to get OOS Rx wholesaler permit too

29. PERMITTING • Establish fingerprint collection & processing (Rule) • use department issued fingerprint cards • submission to FDLE for statewide criminal record check and for forwarding to FBI for national criminal record check • subsequent permit renewals don’t need to submit another card; but will be reprocessed & fee required • $47 processing fee per card

30. PERMITTING • Establish annual fees (Rule - effective 1/1/2004) • Rx manufacturer & repackager $500 - $750 ($600) annually • Rx wholesaler $300 - $800 ($400) annually • Out-of-state Rx wholesaler $300 - $800 ($200-$300) annually • Non-resident Rx manufacturer $300 - $800 annually • Freight forwarder $200 - $300 annually • Certification as designated representative $150 • On-site inspection fee for Out-of-state Rx drug wholesaler (if inspection is conducted $1,000 - $3,000 based on actual cost of inspection.)

31. PERMITTING Section 499.01(1)(a) is reworded so that it authorizes permits to be issued to a natural person. BUT Section 499.012(10) says the name may not include any indicia of attainment of any educational degree, any indicia that the permittee or establishment possesses a professional license, or any name or abbreviation that the department determines is likely to cause confusion or mistake or that the department determines is deceptive, including that of any other entity authorized to purchase prescription drugs.

32. AUTHORIZED DISTRIBUTOR OF RECORD

33. AUTHORIZED DISTRIBUTOR OF RECORD • July 1, 2003 - March 1, 2004 continue under current mode - pedigree goes back to an authorized distributor of record - (purchases from manufacturer)Rule development to modify definition of ‘ongoing relationship’ to facilitate period from July 1, 2003 - March 1, 2004

34. AUTHORIZED DISTRIBUTOR OF RECORD • March 1, 2004 new definition of on-going relationship (ADOR): • a. on the manufacturer’s list of ADOR or • b. 90% of company’s purchases of a mfgr’s products come directly from the mfgr + annual rx sales > $100 Million or • if list lacks 10 companies permitted in Florida (a-b) • annual rx sales > $100 Million + verifiable account with the manufacturer + at least 12 purchases from the manufacturer in 12 months

35. AUTHORIZED DISTRIBUTOR OF RECORD • Manufacturers notified to submit listing by July 1, 2003 (few responded) • Develop database to house ADR data (populate database) • Post manufacturer supplied list on web site • Establish method to receive wholesaler information to be added to ADR list (Rule) (populate database - deadline 3/1/2004)

36. AUTHORIZED DISTRIBUTOR OF RECORD • Concept is not applicable to the specified drugs • ADR for all Rx drugs of that manufacturer • do not have to actually purchase that container from the manufacturer • can aggregate affiliated group members for $100 million in Rx sales

37. PEDIGREE PAPERS

38. PEDIGREE PAPERS • Requirements s. 499.0121(6) • (e) Specified drug list July 1, 2003 / September 1, 2003 until July 1, 2006 • (d) Non-specified July 1, 2003 - March 1, 2004 March 1, 2004 (new definition of ADR) until July 1, 2006 • (f) All rx drugs July 1, 2006 (full implementation) • Excludes Veterinary Legend & Compressed Medical Gases

39. PEDIGREE PAPERS • Requirements 499.0121(6)(e) • July 1, 2003 (specified drug list - 30 drugs) • begin passing and receiving pedigree papers consistent with this requirement so that on September 1, 2003 all inventory on hand can be sold in compliance with the pedigree requirements. • September 1, 2003 • statement “This establishment [or a member of my affiliated group] purchased the specific unit of the specified drug directly from the manufacturer.” OR • full pedigree (under oath) back to manufacturer • Forward to wholesale distributors

40. Combivir (lamivudine/zidovudine) Crixivan (indinavir sulfate) Diflucan (fluconazole) Epivir (lamivudine) Epogen (epoetin alfa) Gamimune (globulin, immune) Gammagard (globulin, immune) Immune globulin Lamisil (terbinafine) Lupron (leuprolide acetate) Neupogen (filgrastim) Nutropin AQ (somatropin, e-coli derived) Panglobulin (globulin, immune) Procrit (epoetin alfa) Retrovir (zidovudine) Risperdal (risperidone) Rocephin (ceftriaxone sodium) Serostim (somatropin, mannalian derived) Sustiva (efavirenz) Trizivir (abacavir sulfate / lamivudine / zidovudine) Venoglobulin (globulin, immune) Videx (didanosine) Viracept (nelfinavir mesylate) Viramune (nevirapine) Zerit (stavudine) Ziagen (abacavir sulfate) Zocor (simvastatin) Zofran (ondansetron) Zoladex (goserelin acetate) Zyprexa (olanzapine) “Specified drug” means all dosage forms, strengths and container sizes of the following prescription drugs:

41. PEDIGREE PAPERS • Requirements 499.0121(6)(d)Non- specified Rx drug • under oath; sales invoice #; and requirements in Rule 64F-12.012(3), F.A.C. • back to authorized distributor of record • July 1, 2003 - March 1, 2004 (purchases from manufacturer) • after March 1, 2004 (on website - list of ADRs) • Forward to wholesale distributors • July 1, 2006 (full implementation)

42. PEDIGREE PAPERS • Requirements 499.0121(6)(f)All Rx drugs (except veterinary legend drugs and compressed medical gases) • July 1, 2006 (full implementation) • back to manufacturer • forward to person who receives the drug (end user - not patients)

43. DRAFT DRAFT

44. PEDIGREE PAPERS • Adopt rules to implement requirements • contents of pedigree paper • additions to specified drug list (Drug Wholesaler Advisory Council & emergency) • authentication guidance

45. AUTHENTICATION • Upon receipt, a wholesaler must review records ... for the acquisition of rx drugs for accuracy and completeness, considering the total facts and circumstances surrounding the transactions and the wholesale distributor involved. This includes authenticating each transaction listed on a pedigree paper. (7/1/2003)

46. AUTHENTICATION • “Authenticate” means to affirmatively verify before any distribution of a legend drug occurs that each transaction listed on the pedigree paper has occurred. • 3felony • Failure to authenticate but attempts to distribute • Falsely swear or certifies has authenticated

47. PEDIGREE PAPERS • Criminal Penalties • Failure to maintain or deliver pedigree paper - 3F • fails to deliver complete and accurate • fails to acquire complete and accurate • knowingly destroys, alters, conceals or fails to maintain • Forgery of pedigree paper - 2 F • knowingly forges, counterfeits, or falsely creates; • falsely represents factual matter on pedigree; • knowingly omits to record required information

48. MISCELLANEOUS

49. MISCELLANEOUS • Drug Wholesaler Advisory Council (11 members) • DOH Secretary makes appointments (term - 4 years) • Secretary of DOH or designee • Secretary of AHCA or designee • 3 employees from different Primary Wholesalers • 1 employee from Secondary Wholesaler • 1 employed by Retail Pharmacy Chain in Florida • 1 pharmacist member of Board of Pharmacy • 1 physician licensed under Ch 458 or 459 • 1 pharmacist employed by hospital pharmacy in FL • 1 employed by pharmaceutical manufacturer

50. MISCELLANEOUS • Drug Wholesaler Advisory Council (11 members) • Secretary is currently seeking nominations Submissions should clearly identify the position to which the nomination is made and include the nominee’s name, mailing address, telephone number, and a narrative description of the person’s qualifications to serve on the council. Submissions should be mailed to the attention of Jerry Hill, R.Ph., C.Ph., Chief of Statewide Pharmaceutical Services, Florida Department of Health, 2818-A Mahan Drive, Tallahassee, Florida 32308, so that the submissions are actually received no later than August 12, 2003.