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