Amendments for SB19-005

Senate Journal, February 1
After consideration on the merits, the Committee recommends that SB19-005 be amended
as follows, and as so amended, be referred to the Committee on Appropriations with
favorable recommendation.

Amend printed bill, page 3, after line 5 insert:

"SECTION 2. In Colorado Revised Statutes, 25.5-1-201, amend
(1) introductory portion, (1)(f), and (1)(g); and add (1)(h) as follows:
25.5-1-201. Programs to be administered by the department
of health care policy and financing. (1) Programs to be administered
and functions to be performed by The department of health care policy
and financing shall be as follows ADMINISTER THE FOLLOWING
PROGRAMS AND PERFORM THE FOLLOWING FUNCTIONS:
(f) The old age pension health and medical care program, as
specified in section 25.5-2-101; and
(g) Programs, services, and supports for persons with intellectual
and developmental disabilities, as specified in article 10 of this title TITLE
25.5; AND
(h) ANY PROGRAM CONCERNING THE WHOLESALE IMPORTATION
OF PRESCRIPTION DRUGS PURSUANT TO PART 2 OF ARTICLE 2.5 OF THIS
TITLE 25.5.".

Renumber succeeding sections accordingly.

Page 3, after line 20 insert:

"(4) "LICENSED PROVIDER" MEANS A PERSON WHO IS LICENSED TO
PRESCRIBE PHARMACEUTICAL PRODUCTS TO CONSUMERS BY A HEALTH
CARE PRESCRIBER BOARD DESCRIBED IN SECTION 24-34-112 (1)(a).".

Renumber succeeding subsection accordingly.

Page 3, line 25, strike "JANUARY" and substitute "JULY".

Page 4, after line 10 insert:

"(a) DESIGNATE AN OFFICE OR DIVISION OF A STATE AGENCY THAT
SHALL BECOME A LICENSED PHARMACEUTICAL WHOLESALER OR
CONTRACT WITH A PHARMACEUTICAL WHOLESALER LICENSED PURSUANT
TO PART 3 OF ARTICLE 42.5 OF TITLE 12;".

Reletter succeeding paragraphs accordingly.

Page 5, strike lines 23 through 26 and substitute:

"(m) SET A MAXIMUM PROFIT MARGIN SO THAT A WHOLESALER,
DISTRIBUTOR, PHARMACY, OR OTHER LICENSED PROVIDER PARTICIPATING
IN THE IMPORTATION PROGRAM MAINTAINS A PROFIT MARGIN THAT IS NO
GREATER THAT THE PROFIT MARGIN THAT THE WHOLESALER,
DISTRIBUTOR, PHARMACY, OR OTHER LICENSED PROVIDER WOULD HAVE
EARNED ON THE EQUIVALENT NONIMPORTED DRUG;".

Page 6, line 6, after "PUB.L. 113-54;" add "AND".

Page 6, line 13, strike "SAVINGS; AND" and substitute "SAVINGS.".

Page 6, strike lines 14 and 15.

Page 6, line 16, strike "hearings" and substitute "meetings".

Page 6, line 17, strike "JANUARY" and substitute "JULY".

Page 6, line 20, strike "PROGRAM;" and substitute "PROGRAM AND ANY
OTHER IMPORTATION OPTIONS THE STATE DEPARTMENT MAY DESCRIBE;".

Page 7, line 3, strike "HEARINGS" and substitute "MEETINGS".

Page 7, line 4, strike "HEARING" and substitute "MEETING".

Page 7, line 5, strike "HEARING" and substitute "MEETING".

Page 7, line 7, strike "HEARINGS" and substitute "MEETINGS".

Page 7, line 8, strike "APRIL" and substitute "NOVEMBER".

Page 7, line 17, strike "MAY" and substitute "DECEMBER".

Page 7, lines 19 and 20, strike "MAY 1, 2020," and substitute "JANUARY
1, 2021,".

Page 8, line 27, strike "TITLE 24," and substitute "TITLE 24 AND SECTION
25.5-1-108,".
Finance



Senate Journal, March 19
After consideration on the merits, the Committee recommends that SB19-005 be amended
as follows, and as so amended, be referred to the Committee of the Whole with favorable
recommendation.

Amend printed bill, page 11, after line 23 insert:

"SECTION 5. Appropriation - adjustments to 2019 long bill.
(1) For the 2019-20 state fiscal year, $1,361,217 is appropriated to the
department of health care policy and financing. This appropriation is
from the general fund. To implement this act, the department may use
this appropriation as follows:
(a) $469,293 for personal services, which amount is based on an
assumption that the department will require an additional 4.1 FTE;
(b) $59,230 for operating expenses;
(c) $186,534 for legal services;
(d) $296,160 for payments to OIT; and
(e) $350,000 for general professional services and special
projects.
(2) For the 2019-20 state fiscal year, $186,534 is appropriated to
the department of law. This appropriation is from reappropriated funds
received from the department of health care policy and financing under
subsection (1)(c) of this section and is based on an assumption that the
department of law will require an additional 1.0 FTE. To implement this
act, the department of law may use this appropriation to provide legal
services for the department of health care policy and financing.
(3) For the 2019-20 state fiscal year, $296,160 is appropriated to
the office of the governor for use by the office of information
technology. This appropriation is from reappropriated funds received
from the department of health care policy and financing under subsection
(1)(d) of this section. To implement this act, the office may use this
appropriation to provide information technology services for the
department of health care policy and financing.
(4) The appropriation in subsection (1)(a) of this section is based
on the assumption that the anticipated amount of federal funds received
for the 2019-20 state fiscal year by the department of health care policy
and financing for personal services will decrease by $70,000.".

Renumber succeeding section accordingly.

Page 1, line 103, strike "RESIDENTS." and substitute "RESIDENTS, AND,
IN CONNECTION THEREWITH, MAKING AN APPROPRIATION.".


Appro-
priations


Senate Journal, March 22
SB19-005 by Senator(s) Rodriguez and Ginal; also Representative(s) Jaquez Lewis--Concerning
wholesale importation of prescription pharmaceutical products from Canada for resale to
Colorado residents.

Amendment No. 1, Health & Human Services Committee Amendment.
(Printed in Senate Journal, February 1, pages 142-143 and placed in members' bill files.)

Amendment No. 2, Appropriations Committee Amendment.
(Printed in Senate Journal, March 19, page 488 and placed in members' bill files.)

Amendment No. 3(L.018), by Senator Ginal.

Amend printed bill, page 4, line 7, strike "384." and substitute "384 AND
INCLUDES ONLY PRESCRIPTION PHARMACEUTICAL PRODUCTS THAT ARE
INTENDED FOR HUMAN CONSUMPTION.".

Senator Hill requested the bill be read at length, then later asked that the reading be
dispensed with.

As amended, ordered engrossed and placed on the calendar for third reading and final
passage.


House Journal, April 24
43 SB19-005 be amended as follows, and as so amended, be referred to
44 the Committee on Appropriations with favorable
45 recommendation:
46
47 Amend reengrossed bill, page 3, strike lines 22 through 27 and substitute:
48
49 "SECTION 3. In Colorado Revised Statutes, add part 2 to article
50 2.5 of title 25.5 as follows:
2 51 PART
52 CANADIAN PRESCRIPTION DRUG
53 IMPORTATION PROGRAM
54 25.5-2.5-201. Definitions. AS USED IN THIS PART 2, UNLESS THE
55 CONTEXT OTHERWISE REQUIRES:
1 (1) "CANADIAN SUPPLIER" MEANS A MANUFACTURER, WHOLESALE
2 DISTRIBUTOR, OR PHARMACY THAT IS APPROPRIATELY LICENSED OR
3 PERMITTED UNDER CANADIAN FEDERAL AND PROVINCIAL LAWS AND
4 REGULATIONS TO MANUFACTURE, DISTRIBUTE, OR DISPENSE PRESCRIPTION
5 DRUGS.
6 (2) "ELIGIBLE IMPORTER" MEANS AN IMPORTER THAT IS DESCRIBED
7 IN SECTION 25.5-2.5-203 (3).
8 (3) "FEDERAL ACT" MEANS THE FEDERAL "FOOD, DRUG, AND
9 COSMETIC ACT", 21 U.S.C. 301 ET SEQ.
10 (4) "MEDICAID PHARMACY" MEANS A PHARMACY REGISTERED
11 PURSUANT TO SECTION 12-42.5-117 THAT HAS A PROVIDER AGREEMENT IN
12 EFFECT WITH THE STATE DEPARTMENT AND IS IN GOOD STANDING WITH
13 THE STATE DEPARTMENT.
14 (5) "PHARMACIST" MEANS A PERSON WHO HOLDS AN ACTIVE AND
15 UNENCUMBERED LICENSE TO PRACTICE PHARMACY PURSUANT TO SECTION
16 12-42.5-112.
17 (6) "PRESCRIPTION DRUG" HAS THE SAME MEANING SET FORTH IN
18 SECTION 12-42.5-102 (34); EXCEPT THAT THE TERM INCLUDES ONLY
19 DRUGS THAT ARE INTENDED FOR HUMAN USE.
20 (7) "PROGRAM" MEANS THE CANADIAN PRESCRIPTION DRUG
21 IMPORTATION PROGRAM CREATED IN SECTION 25.5-2.5-202.
22 (8) "VENDOR" MEANS A VENDOR WITH WHICH THE STATE
23 DEPARTMENT CONTRACTS FOR THE PROVISION OF SERVICES UNDER THE
24 PROGRAM PURSUANT TO SECTION 25.5-2.5-202 (1).
25 25.5-2.5-202. Canadian prescription drug importation
26 program - created - importation process - contract with vendor -
27 vendor duties. (1) THE CANADIAN PRESCRIPTION DRUG IMPORTATION
28 PROGRAM IS CREATED IN THE STATE DEPARTMENT. ON OR BEFORE
29 FEBRUARY 1, 2020, THE STATE DEPARTMENT SHALL CONTRACT WITH ONE
30 OR MORE VENDORS TO PROVIDE SERVICES UNDER THE PROGRAM. FOR
31 THREE YEARS FOLLOWING THE EFFECTIVE DATE OF THIS PART 2, THE
32 SELECTION OF ANY VENDOR PURSUANT TO THIS SUBSECTION (1) IS EXEMPT
33 FROM THE REQUIREMENTS OF THE PROCUREMENT CODE, ARTICLES 101 TO
34 112 OF TITLE 24.
35 (2) (a) EACH VENDOR, IN CONSULTATION WITH THE STATE
36 DEPARTMENT AND ANY OTHER VENDORS, SHALL ESTABLISH A WHOLESALE
37 PRESCRIPTION DRUG IMPORTATION LIST THAT IDENTIFIES THE
38 PRESCRIPTION DRUGS THAT HAVE THE HIGHEST POTENTIAL FOR COST
39 SAVINGS TO THE STATE. IN DEVELOPING THE LIST, EACH VENDOR SHALL
40 CONSIDER, AT A MINIMUM, WHICH PRESCRIPTION DRUGS WILL PROVIDE THE
41 GREATEST COST SAVINGS TO THE STATE, INCLUDING PRESCRIPTION DRUGS
42 FOR WHICH THERE ARE SHORTAGES, SPECIALTY PRESCRIPTION DRUGS, AND
43 HIGH-VOLUME PRESCRIPTION DRUGS. EACH VENDOR SHALL REVISE THE
44 LIST AT LEAST ANNUALLY AND AT THE DIRECTION OF THE STATE
45 DEPARTMENT PURSUANT TO SUBSECTION (2)(b) OF THIS SECTION.
46 (b) THE STATE DEPARTMENT SHALL REVIEW THE WHOLESALE
47 PRESCRIPTION DRUG IMPORTATION LIST AT LEAST EVERY THREE MONTHS
48 TO ENSURE THAT IT CONTINUES TO MEET THE REQUIREMENTS OF THE
49 PROGRAM. THE STATE DEPARTMENT MAY DIRECT A VENDOR TO REVISE
50 THE LIST, AS NECESSARY.
51 (c) EACH VENDOR, IN CONSULTATION WITH THE STATE
52 DEPARTMENT, SHALL IDENTIFY CANADIAN SUPPLIERS WHO ARE IN FULL
53 COMPLIANCE WITH RELEVANT CANADIAN FEDERAL AND PROVINCIAL LAWS
54 AND REGULATIONS AND WHO HAVE AGREED TO EXPORT PRESCRIPTION
55 DRUGS IDENTIFIED ON THE WHOLESALE PRESCRIPTION DRUG IMPORTATION
1 LIST. EACH VENDOR SHALL VERIFY THAT SUCH CANADIAN SUPPLIERS MEET
2 ALL OF THE REQUIREMENTS OF THE PROGRAM AND WILL EXPORT
3 PRESCRIPTION DRUGS AT PRICES THAT WILL PROVIDE COST SAVINGS TO THE
4 STATE. EACH VENDOR SHALL CONTRACT WITH SUCH ELIGIBLE CANADIAN
5 SUPPLIERS, OR FACILITATE CONTRACTS BETWEEN ELIGIBLE IMPORTERS AND
6 CANADIAN SUPPLIERS, TO IMPORT PRESCRIPTION DRUGS UNDER THE
7 PROGRAM.
8 (d) EACH VENDOR SHALL ASSIST THE STATE DEPARTMENT IN
9 DEVELOPING AND ADMINISTERING A DISTRIBUTION PROGRAM WITHIN THE
10 PROGRAM.
11 (e) EACH VENDOR SHALL ASSIST THE STATE DEPARTMENT WITH
12 THE ANNUAL REPORT DESCRIBED IN SECTION 25.5-2.5-205 AND PROVIDE
13 ANY INFORMATION REQUESTED BY THE STATE DEPARTMENT FOR THE
14 REPORT.
15 (f) EACH VENDOR SHALL ENSURE THE SAFETY AND QUALITY OF
16 DRUGS IMPORTED UNDER THE PROGRAM, AS FOLLOWS:
17 (I) (A) FOR AN INITIAL IMPORTED SHIPMENT, ENSURE THAT EACH
18 BATCH OF THE DRUG IN THE SHIPMENT IS STATISTICALLY SAMPLED AND
19 TESTED FOR AUTHENTICITY AND DEGRADATION IN A MANNER CONSISTENT
20 WITH THE FEDERAL ACT; AND
21 (B) FOR ANY SUBSEQUENT IMPORTED SHIPMENT, ENSURE THAT A
22 STATISTICALLY VALID SAMPLE OF THE SHIPMENT IS TESTED FOR
23 AUTHENTICITY AND DEGRADATION IN A MANNER CONSISTENT WITH THE
24 FEDERAL ACT.
25 (II) CERTIFY THAT EACH DRUG:
26 (A) IS APPROVED FOR MARKETING IN THE UNITED STATES AND IS
27 NOT ADULTERATED OR MISBRANDED; AND
28 (B) MEETS ALL OF THE LABELING REQUIREMENTS UNDER 21 U.S.C.
29 SEC. 352.
30 (III) MAINTAIN QUALIFIED LABORATORY RECORDS, INCLUDING
31 COMPLETE DATA DERIVED FROM ALL TESTS NECESSARY TO ENSURE THAT
32 THE DRUG IS IN COMPLIANCE WITH THE REQUIREMENTS OF THIS SECTION;
33 AND
34 (IV) MAINTAIN DOCUMENTATION DEMONSTRATING THAT THE
35 TESTING REQUIRED BY THIS SECTION WAS CONDUCTED AT A QUALIFIED
36 LABORATORY IN ACCORDANCE WITH THE FEDERAL ACT AND ANY OTHER
37 APPLICABLE FEDERAL AND STATE LAWS AND REGULATIONS GOVERNING
38 LABORATORY QUALIFICATIONS.
39 (3) ALL TESTING REQUIRED BY THIS SECTION MUST BE CONDUCTED
40 IN A QUALIFIED LABORATORY THAT MEETS THE STANDARDS UNDER THE
41 FEDERAL ACT AND ANY OTHER APPLICABLE FEDERAL AND STATE LAWS
42 AND REGULATIONS GOVERNING LABORATORY QUALIFICATIONS FOR DRUG
43 TESTING.
44 (4) EACH VENDOR SHALL MAINTAIN A LIST OF ALL ELIGIBLE
45 IMPORTERS THAT PARTICIPATE IN THE PROGRAM.
46 (5) EACH VENDOR SHALL ENSURE COMPLIANCE WITH TITLE II OF
47 THE FEDERAL "DRUG QUALITY AND SECURITY ACT", PUB. L. 113-54, BY
48 ALL CANADIAN SUPPLIERS, ELIGIBLE IMPORTERS, DISTRIBUTORS, AND
49 OTHER PARTICIPANTS IN THE PROGRAM.
50 (6) EACH VENDOR SHALL PROVIDE AN ANNUAL FINANCIAL AUDIT
51 OF ITS OPERATIONS TO THE STATE DEPARTMENT. EACH VENDOR SHALL
52 ALSO PROVIDE QUARTERLY FINANCIAL REPORTS SPECIFIC TO THE PROGRAM
53 AND SHALL INCLUDE INFORMATION CONCERNING THE PERFORMANCE OF
54 ITS SUBCONTRACTORS AND VENDORS. THE STATE DEPARTMENT SHALL
55 DETERMINE THE FORMAT AND CONTENTS OF THE REPORTS.
1 (7) EACH VENDOR SHALL SUBMIT EVIDENCE OF A SURETY BOND
2 WITH ANY BID OR INITIAL CONTRACT NEGOTIATION DOCUMENTS AND
3 SHALL MAINTAIN DOCUMENTATION OF EVIDENCE OF SUCH A BOND WITH
4 THE STATE DEPARTMENT THROUGHOUT THE CONTRACT TERM. THE SURETY
5 BOND MAY BE FROM THIS STATE OR ANY OTHER STATE IN THE UNITED
6 STATES AND MUST BE IN AN AMOUNT OF AT LEAST TWENTY-FIVE
7 THOUSAND DOLLARS. THE SURETY BOND OR COMPARABLE SECURITY
8 ARRANGEMENT MUST INCLUDE THE STATE OF COLORADO AS A
9 BENEFICIARY. IN LIEU OF THE SURETY BOND, A VENDOR MAY PROVIDE A
10 COMPARABLE SECURITY AGREEMENT, SUCH AS AN IRREVOCABLE LETTER
11 OF CREDIT OR A DEPOSIT INTO A TRUST ACCOUNT OR FINANCIAL
12 INSTITUTION THAT INCLUDES THE STATE OF COLORADO AS A BENEFICIARY,
13 PAYABLE TO THE STATE OF COLORADO. THE PURPOSES OF THE BOND OR
14 OTHER SECURITY ARRANGEMENT ARE TO:
15 (a) ENSURE PARTICIPATION OF THE VENDOR IN ANY CIVIL OR
16 CRIMINAL LEGAL ACTION BY THE STATE DEPARTMENT, ANY OTHER STATE
17 AGENCY, OR PRIVATE INDIVIDUALS OR ENTITIES AGAINST THE VENDOR
18 BECAUSE OF THE VENDOR'S FAILURE TO PERFORM UNDER THE CONTRACT,
19 INCLUDING BUT NOT LIMITED TO CAUSES OF ACTIONS FOR PERSONAL
20 INJURY, NEGLIGENCE, AND WRONGFUL DEATH;
21 (b) ENSURE PAYMENT BY THE VENDOR THROUGH THE USE OF A
22 BOND OR OTHER COMPARABLE SECURITY ARRANGEMENT OF ANY LEGAL
23 JUDGMENTS AND CLAIMS THAT ARE AWARDED TO THE STATE, OTHER
24 ENTITIES ACTING ON BEHALF OF THE STATE, INDIVIDUALS, OR
25 ORGANIZATIONS IF THE VENDOR IS ASSESSED A FINAL JUDGMENT OR OTHER
26 MONETARY PENALTY IN A COURT OF LAW FOR A CIVIL OR CRIMINAL ACTION
27 UNDER THE PROGRAM. THE BOND OR COMPARABLE SECURITY
28 ARRANGEMENT MAY BE ACCESSED IF THE VENDOR FAILS TO PAY ANY
29 JUDGMENT OR CLAIM WITHIN SIXTY DAYS AFTER FINAL JUDGMENT.
30 (c) ALLOW FOR CIVIL AND CRIMINAL LITIGATION CLAIMS TO BE
31 MADE AGAINST THE BOND OR OTHER COMPARABLE SECURITY
32 ARRANGEMENTS FOR UP TO ONE YEAR AFTER THE VENDOR'S CONTRACT
33 UNDER THE PROGRAM HAS ENDED WITH THE STATE DEPARTMENT, THE
34 VENDOR'S LICENSE IS NO LONGER VALID, OR THE PROGRAM HAS ENDED,
35 WHICHEVER OCCURS LAST.
36 (8) EACH VENDOR SHALL MAINTAIN INFORMATION AND
37 DOCUMENTATION SUBMITTED UNDER THIS SECTION FOR A PERIOD OF AT
38 LEAST SEVEN YEARS.
39 (9) THE STATE DEPARTMENT MAY REQUIRE EACH VENDOR TO
40 COLLECT ANY OTHER INFORMATION NECESSARY TO ENSURE THE
41 PROTECTION OF THE PUBLIC HEALTH.
42 25.5-2.5-203. Eligible prescription drugs - eligible Canadian
43 suppliers - eligible importers - distribution requirements. (1) AN
44 ELIGIBLE IMPORTER MAY IMPORT A PRESCRIPTION DRUG FROM A
45 CANADIAN SUPPLIER IF:
46 (a) THE DRUG THAT IS TO BE IMPORTED MEETS THE FEDERAL FOOD
47 AND DRUG ADMINISTRATION'S STANDARDS RELATED TO SAFETY,
48 EFFECTIVENESS, MISBRANDING, AND ADULTERATION;
49 (b) IMPORTING THE DRUG WOULD NOT VIOLATE FEDERAL PATENT
50 LAWS;
51 (c) IMPORTING THE DRUG IS EXPECTED TO GENERATE COST
52 SAVINGS; AND
53 (d) THE DRUG IS NOT:
802 54 (I) A CONTROLLED SUBSTANCE AS DEFINED IN 21 U.S.C. SEC.
55 (6);
1 (II) A BIOLOGICAL PRODUCT AS DEFINED IN 42 U.S.C. SEC. 262 (i);
2 (III) AN INFUSED DRUG;
3 (IV) AN INTRAVENOUSLY INJECTED DRUG;
4 (V) A DRUG THAT IS INHALED DURING SURGERY; OR
5 (VI) A DRUG THAT IS A PARENTERAL DRUG, THE IMPORTATION OF
6 WHICH IS DETERMINED BY THE FEDERAL SECRETARY OF HEALTH AND
7 HUMAN SERVICES TO POSE A THREAT TO PUBLIC HEALTH.
8 (2) A CANADIAN SUPPLIER MAY EXPORT PRESCRIPTION DRUGS
9 INTO THE STATE UNDER THE PROGRAM IF THE SUPPLIER:
10 (a) IS IN FULL COMPLIANCE WITH RELEVANT CANADIAN FEDERAL
11 AND PROVINCIAL LAWS AND REGULATIONS;
12 (b) IS IDENTIFIED BY THE VENDOR AS ELIGIBLE TO PARTICIPATE IN
13 THE PROGRAM PURSUANT TO SECTION 25.5-2.5-202 (2)(c); AND
14 (c) SUBMITS AN ATTESTATION THAT THE SUPPLIER HAS A
15 REGISTERED AGENT IN THE UNITED STATES, WHICH ATTESTATION
16 INCLUDES THE NAME AND UNITED STATES ADDRESS OF THE REGISTERED
17 AGENT.
18 (3) THE FOLLOWING ENTITIES ARE ELIGIBLE IMPORTERS AND MAY
19 OBTAIN IMPORTED PRESCRIPTION DRUGS:
20 (a) A PHARMACIST OR WHOLESALER EMPLOYED BY OR UNDER
21 CONTRACT WITH A MEDICAID PHARMACY, FOR DISPENSING TO THE
22 PHARMACY'S MEDICAID RECIPIENTS;
23 (b) A PHARMACIST OR WHOLESALER EMPLOYED BY OR UNDER
24 CONTRACT WITH THE DEPARTMENT OF CORRECTIONS, FOR DISPENSING TO
25 INMATES IN THE CUSTODY OF THE DEPARTMENT OF CORRECTIONS;
26 (c) COMMERCIAL PLANS, AS DEFINED BY RULES PROMULGATED BY
27 THE STATE BOARD AND AS APPROVED BY THE FEDERAL GOVERNMENT; AND
28 (d) A LICENSED COLORADO PHARMACIST OR WHOLESALER
29 APPROVED BY THE STATE DEPARTMENT.
30 (4) (a) THE STATE DEPARTMENT SHALL DESIGNATE AN OFFICE OR
31 DIVISION THAT MUST BE A LICENSED PHARMACEUTICAL WHOLESALER OR
32 THAT SHALL CONTRACT WITH A LICENSED PHARMACEUTICAL WHOLESALER
33 LICENSED PURSUANT TO PART 3 OF ARTICLE 42.5 OF TITLE 12.
34 (b) THE OFFICE OR DIVISION DESIGNATED BY THE STATE
35 DEPARTMENT PURSUANT TO SUBSECTION (4)(a) OF THIS SECTION SHALL:
36 (I) SET A MAXIMUM PROFIT MARGIN SO THAT A WHOLESALER,
37 DISTRIBUTOR, PHARMACY, OR OTHER LICENSED PROVIDER PARTICIPATING
38 IN THE PROGRAM MAINTAINS A PROFIT MARGIN THAT IS NO GREATER THAN
39 THE PROFIT MARGIN THAT THE WHOLESALER, DISTRIBUTOR, PHARMACY,
40 OR OTHER LICENSED PROVIDER WOULD HAVE EARNED ON THE EQUIVALENT
41 NONIMPORTED DRUG;
42 (II) EXCLUDE GENERIC PRODUCTS IF THE IMPORTATION OF THE
43 PRODUCTS WOULD VIOLATE UNITED STATES PATENT LAWS APPLICABLE TO
44 UNITED STATES-BRANDED PRODUCTS;
45 (III) COMPLY WITH THE REQUIREMENTS OF 21 U.S.C. SEC. 360eee
46 TO 360eee-4 AS ENACTED IN TITLE II OF THE FEDERAL "DRUG QUALITY
47 AND SECURITY ACT"; AND
48 (IV) DETERMINE A METHOD FOR COVERING THE ADMINISTRATIVE
49 COSTS OF THE PROGRAM, WHICH METHOD MAY INCLUDE A FEE IMPOSED ON
50 EACH PRESCRIPTION PHARMACEUTICAL PRODUCT SOLD THROUGH THE
51 PROGRAM OR ANY OTHER APPROPRIATE METHOD AS DETERMINED BY THE
52 STATE DEPARTMENT, BUT THE STATE DEPARTMENT SHALL NOT REQUIRE A
53 FEE IN AN AMOUNT THE STATE DEPARTMENT DETERMINES WOULD
54 SIGNIFICANTLY REDUCE CONSUMER SAVINGS.
55 (5) CANADIAN SUPPLIERS AND ELIGIBLE IMPORTERS PARTICIPATING
1 UNDER THE PROGRAM:
2 (a) SHALL COMPLY WITH THE TRACKING AND TRACING
3 REQUIREMENTS OF 21 U.S.C. SEC. 360eee ET SEQ.; AND
4 (b) SHALL NOT DISTRIBUTE, DISPENSE, OR SELL PRESCRIPTION
5 DRUGS IMPORTED UNDER THE PROGRAM OUTSIDE OF THE STATE.
6 (6) A PARTICIPATING ELIGIBLE IMPORTER SHALL SUBMIT TO THE
7 VENDOR ALL OF FOLLOWING INFORMATION ABOUT EACH DRUG TO BE
8 ACQUIRED BY THE IMPORTER UNDER THE PROGRAM:
9 (a) THE NAME AND QUANTITY OF THE ACTIVE INGREDIENT OF THE
10 DRUG;
11 (b) A DESCRIPTION OF THE DOSAGE FORM OF THE DRUG;
12 (c) THE DATE ON WHICH THE DRUG IS RECEIVED;
13 (d) THE QUANTITY OF THE DRUG THAT IS RECEIVED;
14 (e) THE POINT OF ORIGIN AND DESTINATION OF THE DRUG; AND
15 (f) THE PRICE PAID BY THE IMPORTER FOR THE DRUG.
16 (7) A PARTICIPATING CANADIAN SUPPLIER SHALL SUBMIT TO THE
17 VENDOR THE FOLLOWING INFORMATION ABOUT EACH DRUG TO BE
18 SUPPLIED BY THE CANADIAN SUPPLIER UNDER THE PROGRAM:
19 (a) THE ORIGINAL SOURCE OF THE DRUG, INCLUDING:
20 (I) THE NAME OF THE MANUFACTURER OF THE DRUG;
21 (II) THE DATE ON WHICH THE DRUG WAS MANUFACTURED; AND
22 (III) THE COUNTRY, STATE OR PROVINCE, AND CITY WHERE THE
23 DRUG WAS MANUFACTURED;
24 (b) THE DATE ON WHICH THE DRUG IS SHIPPED;
25 (c) THE QUANTITY OF THE DRUG THAT IS SHIPPED;
26 (d) THE QUANTITY OF EACH LOT OF THE DRUG ORIGINALLY
27 RECEIVED AND THE SOURCE OF THE LOT; AND
28 (e) THE LOT OR CONTROL NUMBER AND THE BATCH NUMBER
29 ASSIGNED TO THE DRUG BY THE MANUFACTURER.
30 (8) THE STATE DEPARTMENT SHALL IMMEDIATELY SUSPEND THE
31 IMPORTATION OF A SPECIFIC DRUG OR THE IMPORTATION OF DRUGS BY A
32 SPECIFIC ELIGIBLE IMPORTER IF IT DISCOVERS THAT ANY DRUG OR
33 ACTIVITY IS IN VIOLATION OF THIS SECTION OR ANY FEDERAL OR STATE
34 LAW OR REGULATION. THE STATE DEPARTMENT MAY REVOKE THE
35 SUSPENSION IF, AFTER CONDUCTING AN INVESTIGATION, IT DETERMINES
36 THAT THE PUBLIC IS ADEQUATELY PROTECTED FROM COUNTERFEIT OR
37 UNSAFE DRUGS BEING IMPORTED INTO THIS STATE.
38 25.5-2.5-204. Federal approval. (1) ON OR BEFORE SEPTEMBER
39 1, 2020, THE STATE DEPARTMENT SHALL SUBMIT A REQUEST TO THE
40 UNITED STATES SECRETARY OF HEALTH AND HUMAN SERVICES FOR
41 APPROVAL OF THE PROGRAM UNDER 21 U.S.C. SEC. 384. THE STATE
42 DEPARTMENT SHALL BEGIN OPERATING THE PROGRAM NOT LATER THAN
43 SIX MONTHS AFTER RECEIVING SUCH APPROVAL. THE REQUEST MUST, AT
44 A MINIMUM:
45 (a) DESCRIBE THE STATE DEPARTMENT'S PLAN FOR OPERATING THE
46 PROGRAM;
47 (b) DEMONSTRATE HOW THE PRESCRIPTION DRUGS IMPORTED INTO
48 THE STATE UNDER THE PROGRAM WILL MEET THE APPLICABLE FEDERAL
49 AND STATE STANDARDS FOR SAFETY, EFFECTIVENESS, MISBRANDING, AND
50 ADULTERATION;
51 (c) INCLUDE A LIST OF PRESCRIPTION DRUGS THAT HAVE THE
52 HIGHEST POTENTIAL FOR COST SAVINGS TO THE STATE THROUGH
53 IMPORTATION AT THE TIME THAT THE REQUEST IS SUBMITTED;
54 (d) ESTIMATE THE TOTAL COST SAVINGS ATTRIBUTABLE TO THE
55 PROGRAM; AND
1 (e) INCLUDE A LIST OF POTENTIAL CANADIAN SUPPLIERS FROM
2 WHICH THE STATE WOULD IMPORT PRESCRIPTION DRUGS AND
3 DEMONSTRATE THAT THE SUPPLIERS ARE IN FULL COMPLIANCE WITH
4 RELEVANT CANADIAN FEDERAL AND PROVINCIAL LAWS AND
5 REGULATIONS.
6 (2) UPON RECEIPT OF FEDERAL APPROVAL OF THE PROGRAM, THE
7 STATE DEPARTMENT SHALL NOTIFY THE PRESIDENT OF THE SENATE AND
8 THE SPEAKER OF THE HOUSE OF REPRESENTATIVES, AS WELL AS THE
9 HEALTH AND HUMAN SERVICES COMMITTEE OF THE SENATE AND THE
10 HEALTH AND INSURANCE COMMITTEE OF THE HOUSE OF REPRESENTATIVES,
11 OR ANY SUCCESSOR COMMITTEES. AFTER APPROVAL IS RECEIVED AND
12 BEFORE THE START OF THE NEXT REGULAR SESSION OF THE GENERAL
13 ASSEMBLY IN WHICH THE PROPOSAL COULD BE FUNDED, THE STATE
14 DEPARTMENT SHALL SUBMIT TO ALL PARTIES SPECIFIED IN THIS
15 SUBSECTION (2) A PROPOSAL FOR PROGRAM IMPLEMENTATION AND
16 PROGRAM FUNDING.
136 17 25.5-2.5-205. Reports. (1) NOTWITHSTANDING SECTION 24-1-
18 (11)(a)(I), ON OR BEFORE DECEMBER 1, 2021, AND ON OR BEFORE
19 DECEMBER 1 EACH YEAR THEREAFTER, THE STATE DEPARTMENT SHALL
20 SUBMIT A REPORT TO THE GOVERNOR, THE PRESIDENT OF THE SENATE, AND
21 THE SPEAKER OF THE HOUSE OF REPRESENTATIVES CONCERNING THE
22 OPERATION OF THE PROGRAM DURING THE PREVIOUS FISCAL YEAR. THE
23 REPORT MUST INCLUDE, AT A MINIMUM:
24 (a) A LIST OF THE PRESCRIPTION DRUGS THAT WERE IMPORTED
25 UNDER THE PROGRAM;
26 (b) THE NUMBER OF PARTICIPATING CANADIAN SUPPLIERS AND
27 ELIGIBLE IMPORTERS;
28 (c) THE NUMBER OF PRESCRIPTIONS DISPENSED THROUGH THE
29 PROGRAM;
30 (d) THE ESTIMATED COST SAVINGS DURING THE PREVIOUS FISCAL
31 YEAR AND TO DATE;
32 (e) A DESCRIPTION OF THE METHODOLOGY USED TO DETERMINE
33 WHICH PRESCRIPTION DRUGS SHOULD BE INCLUDED ON THE WHOLESALE
34 PRESCRIPTION DRUG IMPORTATION LIST ESTABLISHED PURSUANT TO
35 SECTION 25.5-2.5-202 (2)(a); AND
36 (f) DOCUMENTATION DEMONSTRATING HOW THE PROGRAM
37 ENSURES THAT:
38 (I) THE VENDOR VERIFIES THAT CANADIAN SUPPLIERS
39 PARTICIPATING IN THE PROGRAM ARE IN FULL COMPLIANCE WITH
40 RELEVANT CANADIAN FEDERAL AND PROVINCIAL LAWS AND
41 REGULATIONS;
42 (II) PRESCRIPTION DRUGS IMPORTED UNDER THE PROGRAM ARE
43 NOT SHIPPED, SOLD, OR DISPENSED OUTSIDE OF THE STATE ONCE IN THE
44 POSSESSION OF THE ELIGIBLE IMPORTER;
45 (III) PRESCRIPTION DRUGS IMPORTED UNDER THE PROGRAM ARE
46 PURE, UNADULTERATED, POTENT, AND SAFE;
47 (IV) THE PROGRAM DOES NOT PUT CONSUMERS AT A HIGHER
48 HEALTH AND SAFETY RISK THAN IF THE PROGRAM DID NOT EXIST; AND
49 (V) THE PROGRAM PROVIDES COST SAVINGS TO THE STATE ON
50 IMPORTED PRESCRIPTION DRUGS.".
51
52 Strike pages 4 through 8.
53
54 Page 9, strike lines 1 through 10.
55
1 Page 9, strike line 27.
2
3 Strike pages 10 and 11.
4
5 Page 12, strike lines 1 through 9.
6
7 Page 12, strike lines 14 through 21.
8
9 Renumber succeeding sections accordingly.
10
11

House Journal, May 1
42 SB19-005 be amended as follows, and as so amended, be referred to
43 the Committee of the Whole with favorable
44 recommendation:
45
46 Amend the Health and Insurance Committee Report, dated April 24,
47 2019, page 2, lines 13 and 14, strike "ON OR BEFORE FEBRUARY 1, 2020,"
48 and substitute "UPON RECEIVING APPROVAL OF THE PROGRAM AS
49 DESCRIBED IN SECTION 25.5-2.5-204 (1),".
50
51 Page 8, after line 19 insert:
52
53 "(2) NOTWITHSTANDING ANY PROVISION OF THIS PART 2 TO THE
54 CONTRARY, THE STATE DEPARTMENT MAY EXPEND MONEY FOR THE
55 PURPOSE OF REQUESTING APPROVAL OF THE PROGRAM AS DESCRIBED IN
1 SUBSECTION (1) OF THIS SECTION BUT THE STATE DEPARTMENT SHALL NOT
2 SPEND ANY OTHER MONEY TO IMPLEMENT THE PROGRAM UNTIL THE STATE
3 DEPARTMENT RECEIVES APPROVAL OF THE PROGRAM AS DESCRIBED IN
4 SAID SUBSECTION (1).".
5
6 Renumber succeeding subsection accordingly.
7
8 Page 8, line 29, strike "(2)" and substitute "(3)".
9
10 Page 9 of the committee report, after line 30 insert:
11
12 "Page 12 of the bill, strike lines 22 through 27 and substitute:
13
14 "SECTION 5. Appropriation - adjustments to 2019 long bill.
15 (1) For the 2019-20 state fiscal year, $1,041,802 is appropriated to the
16 department of health care policy and financing. This appropriation is from
17 the general fund. To implement this act, the department may use this
18 appropriation as follows:
19 (a) $469,293 for use by the executive director's office for personal
20 services, which amount is based on an assumption that the department
21 will require an additional 4.1 FTE;
22 (b) $27,790 for use by the executive director's office for operating
23 expenses;
24 (c) $134,719 for legal services; and
25 (e) $410,000 for general professional services and special
26 projects.
27 (2) For the 2019-20 state fiscal year, $134,719 is appropriated to
28 the department of law. This appropriation is from reappropriated funds
29 received from the department of health care policy and financing under
30 subsection (1)(c) of this section and is based on an assumption that the
31 department of law will require an additional 0.7 FTE. To implement this
32 act, the department of law may use this appropriation to provide legal
33 services for the department of health care policy and financing.
34 (3) The appropriation in subsection (1)(a) of this section is based
35 on the assumption that the anticipated amount of federal funds received
36 for the 2019-20 state fiscal year by the department of health care policy
37 and financing for personal services will decrease by $70,000.".
38
39 Page 13 of the bill, strike lines 1 through 24.".
40
41

House Journal, May 2
19 Amend revised bill, page 3, before line 27 insert:
20
21 "25.5-2.5-201. Short title. THE SHORT TITLE OF THIS PART 2 IS THE
22 "DR. IRENE AGUILAR CANADIAN PRESCRIPTION DRUG IMPORTATION
23 ACT".".
24
25 Renumber succeeding CRS sections accordingly.
26
204 27 Page 4, line 8, strike "25.5-2.5-203 (3)." and substitute "25.5-2.5-
28 (3).".
29
30 Page 4, line 22, strike "25.5-2.5-202." and substitute "25.5-2.5-203.".
31
203 32 Page 4, line 25, strike "25.5-2.5-202 (1)." and substitute "25.5-2.5-
33 (1).".
34
205 35 Page 5, line 3, strike "25.5-2.5-204 (1)," and substitute "25.5-2.5-
36 (1),".
37
38 Page 6, line 15, strike "25.5-2.5-205" and substitute "25.5-2.5-206".
39
40 Page 10, line 18, strike "25.5-2.5-202 (2)(c);" and substitute
41 "25.5-2.5-203 (2)(c);".
42
43 Page 15, line 22, strike "25.5-2.5-202 (2)(a);" and substitute
44 "25.5-2.5-203 (2)(a);".
45
46 Page 16, line 14, strike "25.5-2.5-205," and substitute "25.5-2.5-206,".
47
48 The amendment was declared passed by the following roll call vote:
49
50 YES 39 NO 23 EXCUSED 3 ABSENT
51 Arndt Y Exum E Landgraf N Saine E
52 Baisley N Froelich Y Larson N Sandridge N
53 Beckman N Galindo Y Lewis N Singer Y
54 Benavidez Y Garnett Y Liston N Sirota Y
55 Bird Y Geitner N Lontine Y Snyder Y
1 Bockenfeld N Gonzales-Gutierrez Y McCluskie Y Soper N
2 Buck N Gray Y McKean N Sullivan Y
3 Buckner Y Hansen Y McLachlan Y Tipper Y
4 Buentello Y Herod E Melton Y Titone Y
5 Caraveo Y Hooton Y Michaelson Jenet Y Valdez A. Y
6 Carver N Humphrey N Mullica Y Valdez D. Y
7 Catlin N Jackson Y Neville N Van Winkle N
8 Coleman Y Jaquez Lewis Y Pelton N Weissman Y
9 Cutter Y Kennedy Y Ransom N Will N
10 Duran Y Kipp Y Rich N Williams D. N
11 Esgar Y Kraft-Tharp Y Roberts Y Wilson N
12 Speaker Y
13
14 The question being, "Shall the bill, as amended, pass?".
15 A roll call vote was taken. As shown by the following recorded vote, a
16 majority of those elected to the House voted in the affirmative, and the
17 bill, as amended, was declared passed.
18
19 YES 41 NO 22 EXCUSED 2 ABSENT
20 Arndt Y Exum E Landgraf N Saine E
21 Baisley N Froelich Y Larson N Sandridge N
22 Beckman N Galindo Y Lewis N Singer Y
23 Benavidez Y Garnett Y Liston N Sirota Y
24 Bird Y Geitner N Lontine Y Snyder Y
25 Bockenfeld Y Gonzales-Gutierrez Y McCluskie Y Soper N
26 Buck N Gray Y McKean N Sullivan Y
27 Buckner Y Hansen Y McLachlan Y Tipper Y
28 Buentello Y Herod Y Melton Y Titone Y
29 Caraveo Y Hooton Y Michaelson Jenet Y Valdez A. Y
30 Carver N Humphrey N Mullica Y Valdez D. Y
31 Catlin N Jackson Y Neville N Van Winkle N
32 Coleman Y Jaquez Lewis Y Pelton N Weissman Y
33 Cutter Y Kennedy Y Ransom N Will N
34 Duran Y Kipp Y Rich N Williams D. N
35 Esgar Y Kraft-Tharp Y Roberts Y Wilson N
36 Speaker Y
37 Co-sponsor(s) added: Representative(s) Bird, Buckner, Buentello, Caraveo,
38 Cutter, Esgar, Froelich, Galindo, Gonzales-Gutierrez, Gray, Hansen, Herod,
39 Hooton, Jackson, Kennedy, Kipp, Lontine, McCluskie, Melton, Michaelson
40 Jenet, Mullica, Singer, Sirota, Snyder, Sullivan, Tipper, Titone, Valdez A.