There are two types of pedigree papers required, depending upon
whether the prescription drug being sold to another prescription
drug wholesaler is on the list of specified drugs or is not on the
list.
If a prescription drug is on the specified drug list, then a
prescription drug wholesaler selling the prescription drug to
another prescription drug wholesaler must comply with the pedigree
paper requirements of s. 499.0121(6)(e), F.S.
If a prescription drug is NOT on the specified drug list, then
the sale of the prescription drug to another prescription drug
wholesaler must comply with the pedigree paper requirements of s.
499.0121(6)(d), F.S.
Effective July 1, 2006 all wholesale distributions of
prescription drugs will be subject to the pedigree paper
requirements of s. 499.0121(6)(f), F.S.
DH2129 Prescription (Legend) Drug Pedigree
Form-(Optional until July 1, 2006)
in PDF Format
A purchasing
wholesale distributor has responsibilities with respect to the
purchase of a prescription drug as set forth
in s. 499.0121(4), F.S.
(2003).
SPECIFIED DRUG LIST FOR PEDIGREE PAPERS
THREE DRUGS ADDED TO SPECIFIED DRUG LIST
The final rule to
add Bextra, Celebrex, and Viagra to the specified list for pedigrees
back to the manufacturer (consistent with the requirements of s.
499.0121(6)(e), F.S.) was filed with the Bureau of Administrative
Code on May 9, 2005. It becomes a final rule on May 29,
2005. The Florida Statutes provide an additional 60 days
before the rule is enforceable, which will be July 28,
2005. We suggest
wholesalers begin requesting pedigrees and rotate your inventory of
these products so that the inventory you have on hand on July 28,
2005 can be fully distributed in compliance with the
law.
Any specified drug distributed by a
wholesale distributor to a wholesale distributor on or after
September 1, 2003, must comply with the pedigree paper requirements
of s. 499.0121(6)(e), F.S. (2003).
** NOTE: After much
discussion concerning whether the list of specified drugs
includes generic formulations, the department has taken the position
that except for the immune globulins that are specifically
identified on the list, the pedigree paper / statement requirements
of 499.0121(6)(e), F.S. (2003) are only required for the named
products on the current list that was effective on or about July 1,
2003. In other words, generics or other products with the same
chemical name are not included except for the various immune
globulins.
SPECIFIED DRUG LIST FOR
PEDIGREE PAPERS
The list of specified drugs for which the pedigree paper
requirements of s. 499.0121(6)(e), F.S. follows:
64F-12.001(2),
Florida Administrative Code
(w) “Specified drug”
means all dosage forms, strengths and container sizes of the following prescription
drugs:
1. Combivir (lamivudine/zidovudine);
2. Crixivan (indinavir sulfate);
3. Diflucan (fluconazole);
4. Epivir (lamivudine);
5. Epogen (epoetin alfa);
6. Gamimune (globulin, immune);
7. Gammagard (globulin, immune);
8. Immune globulin;
9. Lamisil (terbinafine);
10. Lipitor (atorvastatin calcium); (fully effective
3/29/2004)
11. Lupron (leuprolide acetate);
12. Neupogen (filgrastim);
13. Nutropin AQ (somatropin, e-coli derived);
14. Panglobulin (globulin, immune);
15. Procrit (epoetin alfa);
16. Retrovir (zidovudine);
17. Risperdal (risperidone);
18. Rocephin (ceftriaxone sodium);
19. Serostim (somatropin, mannalian derived);
20. Sustiva (efavirenz);
21. Trizivir (abacavir sulfate/lamivudine/zidovudine);
22. Venoglobulin (globulin, immune);
23. Videx (didanosine);
24. Viracept (nelfinavir mesylate);
25. Viramune (nevirapine);
26. Zerit (stavudine);
27. Ziagen (abacavir sulfate);
28. Zocor (simvastatin);
29. Zofran (ondansetron);
30. Zoladex (goserelin acetate); and
31. Zyprexa (olanzapine).
