FORTY-SEVENTH LEGISLATURE

FIRST SESSION, 2005

March 17, 2005

Mr. Speaker:

    Your JUDICIARY COMMITTEE, to whom has been referred

SENATE BILL 413, as amended

has had it under consideration and reports same with recommendation that it DO PASS, amended as follows:

     1. Strike Senate Public Affairs Committee Amendment 2.

     2. On page 1, line 13, after the second occurrence of "ACT", insert "AND IN THE NEW MEXICO DRUG, DEVICE AND COSMETIC ACT; PROVIDING FOR PEDIGREES;".

     3. On page 4, line 25, after "means", strike the remainder of the line and on page 5, strike lines 1 through 9 in their entirety and insert in lieu thereof the following:

"a drug that is deliberately and fraudulently mislabeled with respect to its identity, ingredients or sources. Types of such pharmaceutical counterfeits may include:

                (1) "identical copies", which are counterfeits made with the same ingredients, formulas and packaging as the originals but not made by the original manufacturer;

                (2) "look-alikes", which feature high-quality packaging and convincing appearances but contain little or no active ingredients and may contain harmful substances;

                (3) "rejects", which are drugs that have been rejected by the manufacturer for not meeting quality standards; and

                (4) "re-labels", which have passed their expiration dates or have been distributed by unauthorized foreign sources and may include placebos created for late-phase clinical trials;".

     4. On page 11, line 7, strike "and".

     5. On page 11, line 9, after "relationship", strike the remainder of the line, strike all of lines 10 and 11 and insert in lieu thereof ", as defined by the practitioner's licensing board, between the practitioner and the patient; and".

     6. On page 11, between lines 11 and 12, insert the following new subsection to read:

          "AA. "pedigree" means the recorded history of a drug."".

     7. On page 12, line 9, after "manufacturers", insert ", wholesalers".

     8. On page 12, line 12, before "hospitals", insert "wholesalers,".

     9. On page 22, between lines 2 and 3, insert the following new section:

     "Section 6. Section 26-1-18 NMSA 1978 (being Laws 1972, Chapter 84, Section 50) is amended to read:

     "26-1-18. PROMULGATING REGULATIONS--PROCEDURE.--

          A. The board may promulgate regulations for the efficient enforcement of the New Mexico Drug, Device and Cosmetic Act. The board shall conform the regulations promulgated under the New Mexico Drug, Device and Cosmetic Act, insofar as practical, with regulations promulgated under the federal act as defined in Section 26-1-2 NMSA 1978.

          B. The board [of pharmacy] shall, by regulation, declare a substance a "dangerous drug" when necessary, and notification shall be sent to all registered pharmacies in the state within sixty days of the adoption of the regulation.

          C. The board shall promulgate the requirements for a pedigree.

          D. All regulations promulgated by the board shall be in accordance with the Uniform Licensing Act."".

     10. Renumber the succeeding sections accordingly.

                             Respectfully submitted,

Joseph Cervantes, Chairman

Adopted     Not Adopted

           (Chief Clerk)                            (Chief Clerk)

Date

The roll call vote was 6 For 0 Against

Yes:      6

No:       0

Excused:  Balderas, Beam, Marquardt, Stewart, Youngberg

Absent:   None

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