Massachusetts 2025-2026 Regular Session

Massachusetts House Bill H2472 Compare Versions

Only one version of the bill is available at this time.

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1	1	1 of 1
2	2	HOUSE DOCKET, NO. 1476 FILED ON: 1/15/2025
3	3	HOUSE . . . . . . . . . . . . . . . No. 2472
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Kathleen R. LaNatra
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act protecting patient safety regarding non-FDA approved drugs.
13	13	_______________
14	14	PETITION OF:
15	15	NAME:DISTRICT/ADDRESS :DATE ADDED:Kathleen R. LaNatra12th Plymouth1/15/2025Patrick Joseph Kearney4th Plymouth2/3/2025 1 of 4
16	16	HOUSE DOCKET, NO. 1476 FILED ON: 1/15/2025
17	17	HOUSE . . . . . . . . . . . . . . . No. 2472
18	18	By Representative LaNatra of Kingston, a petition (accompanied by bill, House, No. 2472) of
19	19	Kathleen R. LaNatra and Patrick Joseph Kearney relative to the distribution of compounded
20	20	medications. Public Health.
21	21	The Commonwealth of Massachusetts
22	22	_______________
23	23	In the One Hundred and Ninety-Fourth General Court
24	24	(2025-2026)
25	25	_______________
26	26	An Act protecting patient safety regarding non-FDA approved drugs.
27	27	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
28	28	of the same, as follows:
29	29	1 Section 1. As used in this section, the following words shall have the following
30	30	2meanings:
31	31	3 a) "Compounded Medication" means a medication that is prepared, mixed, assembled,
32	32	4altered, or otherwise modified by a licensed pharmacist to meet the unique needs of an individual
33	33	5patient pursuant to a prescription.
34	34	6 b) "Retail Pharmacy" means any establishment, including a community pharmacy,
35	35	7licensed by the state to dispense prescription medications directly to patients.
36	36	8 c) "Resale" means selling, distributing, or otherwise transferring a medication that a retail
37	37	9pharmacy has purchased, in any quantity, to another entity or individual who is not the patient
38	38	10for whom the medication was originally compounded.
39	39	11 Section 2. 2 of 4
40	40	12 In order to ensure the safe and ethical distribution of compounded medications:
41	41	13 (a) No retail pharmacy shall resell compounded medications.
42	42	14 (b) Compounded medications prepared by a retail pharmacy shall be dispensed only to
43	43	15the patient for whom the medication was originally compounded, pursuant to a valid
44	44	16prescription.
45	45	17 (c) Any violation of this section shall subject the retail pharmacy to disciplinary actions
46	46	18as determined by the state's Board of Registration in Pharmacy, including but not limited to
47	47	19fines, suspension, or revocation of the pharmacy's license.
48	48	20 Section 3.
49	49	21 (1) The resale of a compounded drug that is labeled “not for resale” in accordance with
50	50	22section (2)(c)(ix) is prohibited.
51	51	23 (2) The label of any drug compounded or repackaged by an outsourcing facility shall
52	52	24include, but not be limited to the following:
53	53	25 (a) a statement that the compounded drug is a compounded drug or a reasonable
54	54	26comparable alternative statement that prominently identifies the drug as a compounded drug;
55	55	27 (b) the name, address, and phone number of the applicable outsourcing facility; and
56	56	28 (c) with respect to the compounded drug:
57	57	29 (i) the lot or batch number;
58	58	30 (ii) the established name of the drug; 3 of 4
59	59	31 (iii) the dosage form and strength;
60	60	32 (iv) the statement of quantity or volume, as appropriate;
61	61	33 (v) the date that the drug was compounded;
62	62	34 (vi) the expiration date;
63	63	35 (vii) storage and handling instructions;
64	64	36 (viii) the NDC number, if available;
65	65	37 (ix) the statement that the drug is not for resale, and if the drug product is distributed by
66	66	38an outsourcing facility other than pursuant to a prescription for an individual identified patient,
67	67	39the statement “office use only”;
68	68	40 (x) a list of the active and inactive ingredients, identified by established name, and the
69	69	41quantity or proportion of each ingredient.
70	70	42 (3) The container from which the individual units of the compounded drug are removed
71	71	43for dispensing or for administration (such as a plastic bag containing individual product syringes)
72	72	44shall include-- (a) a list of active and inactive ingredients, identified by established name, and the
73	73	45quantity or proportion of each ingredient; (b) the following information to facilitate adverse
74	74	46event reporting: www.fda.gov/medwatch and 1-800-FDA-1088 (or any successor Internet Web
75	75	47site or phone number); and (c) directions for use, including, as appropriate, dosage and
76	76	48administration.
77	77	49 (4) No compounded or repackaged drug will be sold or transferred by any entity other
78	78	50than the outsourcing facility that compounded or repackaged such drug. This does not prohibit 4 of 4
79	79	51the administration of a drug in a health care setting or an outsourcing facility dispensing a drug
80	80	52pursuant to a properly executed prescription.
81	81	53 (5) A compounded drug labeled “office use only” in accordance with section (2)(c)(ix)
82	82	54shall be administered in the office and not dispensed to the patient.
83	83	55 Section 4. Enforcement
84	84	56 (a) The state's Board of Registration in Pharmacyshall have the power to enforce the
85	85	57provisions of this Act.
86	86	58 (b) The regulatory authority is authorized to promulgate rules and regulations necessary
87	87	59for the implementation and enforcement of this Act.
88	88	60 Section 5. Severability
89	89	61 If any provision of this Act, or the application thereof to any person or circumstance, is
90	90	62held invalid, the remainder of the Act and the application of such provision to other persons or
91	91	63circumstances shall not be affected thereby.