64F-12.001: General Regulations; Definitions
64F-12.015: Licensing, Application, Permitting
PURPOSE AND EFFECT: The proposed amendment to Rule 64F-12.001, F.A.C., adds the definition of “propagation” as this term appears in the definition of “manufacture” at Section 499.003(27), F.S. The definition clarifies that the manufacturing process includes the various establishments that may be part of that process, including a private relabeler and an affiliated or contract distribution center. The proposed amendment to Rule 64F-12.015, F.A.C., expands the scope of the on-site inspection requirement to additional permit applicants within the scope of Chapter 499, F.S. The amendment to this rule also provides the department with an option to on-site inspection of a permit applicant’s establishment. This option is designed to protect public health when the department’s workload requires an alternative to an inspection. Finally, the proposed amendment to this rule also adopts a new attachment to the Application for Permit under Chapter 499, F.S., which attachment is directed to manufacturer and prescription drug repackager permit applicants located in Florida.
SUMMARY: The proposed amendment to Rule 64F-12.001, F.A.C., adds the definition of “propagation” clarifying that term as it appears in the definition of “manufacture” at Section 499.003(27), F.S. The proposed amendment to Rule 64F-12.015, F.A.C., expands the scope of the on-site inspection requirement to additional permit applicants within the scope of Chapter 499, F.S., provides the department with an option to on-site inspection of a permit applicant’s establishment, and adopts a new attachment to the Application for Permit under Chapter 499, F.S., which attachment is directed to manufacturer and prescription drug repackager permit applicants located in Florida.
SUMMARY OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 499.05, 499.0121, 499.0122, 499.013, 499.014, 499.052 FS.
LAW IMPLEMENTED: 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.051, 499.052 FS.
A HEARING WILL BE HELD AT THE TIME, DATE AND PLACE SHOWN BELOW:
TIME AND DATE: May 15, 2006, 1:00 p.m. eastern daylight savings time.
PLACE: Ramada Inn Conference Center, Windsor Room, 2900 North Monroe Street, Tallahassee, Florida.
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least days before the workshop/meeting by contacting: Maxine Wenzinger at (850)245-4736. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, R. Ph., Executive Director, Board of Pharmacy-Drugs Devices and Cosmetics, 4052 Bald Cypress Way, Mail Bin C-04, Tallahassee, Florida 32399, (850)245-4292.
THE FULL TEXT OF THE PROPOSED RULE IS:
64F-12.001 General Regulations; Definitions.
(1) No change.
(2) In addition to definitions contained in Sections 499.003, 499.012 (1), 499.0121 (6), 499.0122(1), 499.028 (1), and 499.61, F.S., the following definitions apply to Rule Chapter 64F-12, F.A.C.:
(a) through (l) No change.
(m) “Propagation” as used under the definition of “manufacture” at Section 499.003(27), F.S., means for purposes of permitting under s. 499.013, F. S., the holder of an approved New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or New Animal Drug Application (NADA); a private label distributor and the private label distributor’s preion drugs are originally manufactured and labeled for the distributor and have not been repackaged; or the distribution point for the manufacturer, contract manufacturer or private label distributor whether the establishment is a member of the manufacturer’s affiliated group or is a contract distribution site.
(n) (m) “Ongoing relationship” means: For a preion drug other than a specified drug:
1. An association that exists when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer’s product(s) for a period of time or for a number of shipments and at least one sale is made under that agreement; or
2. The name of the authorized distributor of record is entered on the manufacturer’s list of authorized distributors of record or equivalent list; or
3. At least three purchases of a manufacturer’s product(s) are made directly from that manufacturer within a six month period from the date for which the authorized distributor of record relationship is claimed.
(o) (n) “Practitioner” means a person who is duly licensed and authorized by laws of the state to administer, prescribe, or dispense, as appropriate, a drug or device for medical purposes.
(p) (o) “Provides preion services to the public” – means, for the purposes of the retail pharmacy wholesaler permit, holding the pharmacy out to the public through prominently displayed pharmacy signs on the exterior of the building and adequate inventory on hand to fill a variety of preions for a variety of medical conditions that would be required by the public generally.
(q) (p) “Product” – anything produced or made either naturally or artificially.
(r) (q) “Readily available” and “readily retrievable” mean that records, either hard copy or computerized, are organized in such a manner that they can be quickly and easily retrieved during an inspection; individual records can be produced within minutes of the request (unless the permitted address is not within the state in which case a 48 hour timeframe is available for producing records). Required records that are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems are kept in such a manner so that they can be separated out from all other records in a reasonable time.
(s) (r) “Repackaging or otherwise changing the container, wrapper, or labeling to further the distribution” means:
1. Altering a packaging component that is or may be in direct contact with the drug, device, or cosmetic. For example, repackaging from bottles of 1000 to bottles of 100.
2. Altering a manufacturer’s package for sale under a label different from the manufacturer. For example, a kit that contains an injectable vaccine from manufacturer A; a syringe from manufacturer B; alcohol from manufacturer C; and sterile gauze from manufacturer D packaged together and marketed as an immunization kit under a label of manufacturer Z.
3. Altering a package of multiple-units, which the manufacturer intended to be distributed as one unit, for sale or transfer to a person engaged in the further distribution of the product. This does not include:
a. Selling or transferring an individual unit which is a fully labeled self-contained package that is shipped by the manufacturer in multiple units, or
b. Selling or transferring a fully labeled individual unit, by adding the package insert, by a person authorized to distribute preion drugs to an institutional pharmacy permit, health care practitioner or emergency medical service provider for the purpose of administration and not for dispensing or further distribution.
(t) (s) “Rx” – means preion.
(u) (t) “
(v) (u) “Separate and distinct cosmetic product” – a cosmetic product for that establishment which is, or will be sold, distributed, or given away. The adding of color, flavor, or scents does not make a separate and distinct cosmetic product for each variation.
(w) (v) “Separate and distinct device product” – a device product in its finished form for that manufacturer which is, or will be sold, distributed, or given away. The function or use of the device determines whether a device is separate and distinct.
(x) (w) “Separate and distinct drug product” – a drug product in the finished form and strength for that manufacturer which is, or will be sold, distributed or given away.
(y) (x) “Specified drug” means all dosage forms, strengths and container sizes of the following preion drugs:
1. Bextra (valdecoxib);
2. Celebrex (celecoxib);
4. Crixivan (indinavir sulfate);
5. Diflucan (fluconazole);
6. Epivir (lamivudine);
7. Epogen (epoetin alfa);
8. Gamimune (globulin, immune);
9. Gammagard (globulin, immune);
10. Immune globulin;
11. Lamisil (terbinafine);
12. Lipitor (atorvastatin calcium);
13. Lupron (leuprolide acetate);
14. Neupogen (filgrastim);
15. Nutropin AQ (somatropin, e-coli derived);
16. Panglobulin (globulin, immune);
17. Procrit (epoetin alfa);
18. Retrovir (zidovudine);
19. Risperdal (risperidone);
20. Rocephin (ceftriaxone sodium);
21. Serostim (somatropin, mannalian derived);
22. Sustiva (efavirenz);
23. Trizivir (abacavir sulfate/lamivudine/zidovudine);
24. Venoglobulin (globulin, immune);
25. Viagra (sildenafil citrate);
26. Videx (didanosine);
27. Viracept (nelfinavir mesylate);
28. Viramune (nevirapine);
29. Zerit (stavudine);
30. Ziagen (abacavir sulfate);
31. Zocor (simvastatin);
32. Zofran (ondansetron);
33. Zoladex (goserelin acetate); and
34. Zyprexa (olanzapine).
(z) (y) “State Current Good Manufacturing Practices” means current good manufacturing practices and quality system regulations as prescribed as of
(aa) (z) “Unapproved new drug” – means any drug which has not been approved or otherwise authorized for use under the federal act, 21 U.S.C. ss. 301 et seq., and the regulations promulgated thereunder or which does not have a Notice of Claimed Investigational Exemption on file with the United States Food and Drug Administration.
(bb) (aa) “Valid client-veterinarian relationship” – means one in which (1) a veterinarian has assumed the responsibility for making medical judgments regarding the health of an animal and the need for medical treatment, and the client (the owner or other caretaker of the animal or animals) has agreed to follow the instructions of the veterinarian; (2) there is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and (3) the veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.
(cc) (bb) “Verifiable account” means a number issued by the manufacturer to a wholesaler when the wholesaler sets up an account with the manufacturer for the purchase of a preion drug from that manufacturer that uniquely identifies the wholesaler and that is to be used on a recurring basis.
(dd) (cc) “Wholesale distribution” means distribution of preion drugs to persons other than a consumer or patient as set forth in s. Section 499.012(1)(a), F.S.
(ee) (dd) “Wholesaler” means a person who engages in the wholesale distribution of a preion drug.
(ff) (ee) “Written agreement” means any type of written correspondence or documentation to establish an account for ongoing sales of preion drugs by the manufacturer to that wholesaler.
Specific Authority 499.05, 499.61, 499.701 FS. Law Implemented 499.003, 499.004, 499.005, 499.0054, 499.0057, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.033, 499.035, 499.039, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75 FS. History–New 1-1-77, Amended 12-12-82, 1-30-85, Formerly 10D-45.31, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.031, Amended 1-26-99, 4-17-01, 6-30-03, 10-7-03, 1-1-04, 1-29-04, 5-29-05, 1-19-06, 2-14-06,________.
64F-12.015 Licensing, Application, Permitting.
(1) through (2) No change
(3) ON-SITE INSPECTIONS. Passing an on-site inspection is a prerequisite to issuance of a new permit, whether based on an initial application or change of address application, for the following permit types: Preion Drug Manufacturer, Preion Drug Repackager, Device Manufacturer, Compressed Medical Gases Manufacturer, Over-the-Counter Drug Manufacturer, Cosmetic Manufacturer, Preion Drug Wholesaler, Compressed Medical Gases Wholesaler, Retail Pharmacy Wholesaler, Freight Forwarder, Veterinary Preion Drug Wholesaler located in Florida, Complimentary Drug Distributor located in Florida, Veterinary Legend Drug Retailer, Medical Oxygen Retailer, and Restricted Rx Drug Distributor permits for the Health Care Entity, Reverse Distributor, and Destruction facilities. However, the department may elect to perform an inspection of the Restricted Rx Drug Distributor – Charitable Organization, Government Program, or Institutional Research as a condition of permitting but an on-site inspection fee will not be assessed.
(d) The department may will request from the applicant written documentation to evidence compliance with the requirements of Chapter 499, F.S., when workload prevents the department from conducting an on-site inspection cannot be completed within 65 30 days of receipt of a completed application for a permit requiring an on-site inspection or a written request for a change of address. The department may request documentation addressing at a minimum compliance with Section 499.0121, F. S., as it relates to the type of permit for which the person applied. The applicant will be required to specify by page number and paragraph on that page the policies and procedures required under Section. 499.0121(7), F. S., that address matters specific to the type of permit for which the person applied. The applicant’s failure to respond to the department’s request within the timeframe specified in the department’s correspondence requesting this documentation may be grounds for denial of the permit application.
(6) MANUFACTURER PERMITS.
(a) through (b) No change.
(c) Application requirements for manufacturers and preion drug repackagers located in
1. Contact the department’s Bureau of Statewide Pharmaceutical Services to request an application or download the application from the bureau’s web site.
2. File with the department a completed application for a permit using an original Form DH 1033, “Application for Permit Under Chapter 499, F.S.,” effective August 2004, and the attachment for a Manufacturer, effective XXXXXXX, which are is incorporated by reference herein.
3. Pay the appropriate fee(s) as required by Rule 64F-12.018, F.A.C.
4. Comply with all the requirements for permitting provided in Chapter 499, F.S., and this rule chapter.
5. Have an FDA establishment registration number, or unless the application is for a cosmetic manufacturer, provide documentation to the department supporting an exemption from FDA registration.
(6) (d) No change.
(7) through (11) No change.
Specific Authority 499.01, 499.012, 499.0121(1), 499.0122, 499.013, 499.014, 499.028, 499.04, 499.041, 499.05, 499.62, 499.63, 499.64, 499.66, 499.67, 499.701 FS. Law Implemented 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.028(6), 499.04, 499.004, 499.041, 499.05, 499.06, 499.006, 499.007, 499.052, 499.062, 499.063, 499.064, 499.066, 499.067 FS. History–New 12-12-82, Amended 7-8-84, 1-30-85, Formerly 10D-45.54, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.054, Amended 1-26-99, 4-17-01, 10-29-02, 7-6-03, 1-1-04, 9-13-04, 10-3-05, 1-19-06,_________.