An Act protecting patient safety regarding non-FDA approved drugs
Generates a plain-language summary of the bill text and history.
Chapter 112 of the General Laws is hereby amended by inserting after section 297 the following section:-
(a) For the purposes of this section, the following words shall have the following meanings: "Compounded medication", a medication that is prepared, mixed, assembled, altered, or otherwise modified by a licensed pharmacist to meet the unique needs of an individual patient pursuant to a prescription. "Retail pharmacy", any establishment, including a community pharmacy, licensed by the state to dispense prescription medications directly to patients. "Resale", the selling, distributing, or otherwise transferring a medication that a retail pharmacy has purchased, in any quantity, to another entity or individual who is not the patient for whom the medication was originally compounded. (b) No retail pharmacy shall resell compounded medications, and compounded medications prepared by a retail pharmacy shall be dispensed only to the patient for whom the medication was originally compounded, pursuant to a valid prescription. (c) Any violation of subsection (b) of this section shall subject the retail pharmacy to disciplinary actions as determined by the board of registration in pharmacy, including, but not limited to fines, suspension, or revocation of the pharmacy's license. (d) The resale of a compounded drug that is labeled “not for resale” in accordance with subsection (b) of this section is prohibited. (e) In addition to the provisions described in section 21 of chapter 94C of the General Laws, the label of any drug compounded or repackaged by an outsourcing facility shall include, but not be limited to, the following: (1) the name, address, and phone number of the applicable outsourcing facility; and (2) with respect to the compounded drug: (i) the lot or batch number; (ii) the dosage form and strength; (iii) the statement of quantity or volume, as appropriate; (iv) the expiration date; (v) storage and handling instructions; (vi) the National Drug Code number, if available; (vii) the statement that the drug is not for resale, and if the drug product is distributed by an outsourcing facility other than pursuant to a prescription for an individual identified patient, the statement “office use only”; and (viii) a list of the active and inactive ingredients, identified by established name, and the quantity or proportion of each ingredient. (f) The container from which the individual units of the compounded drug are removed for dispensing or for administration, such as a plastic bag containing individual product syringes, shall include a list of active and inactive ingredients, identified by established name, and the quantity or proportion of each ingredient. (g) No compounded or repackaged drug will be sold or transferred by any entity other than the outsourcing facility that compounded or repackaged such drug. This does not prohibit the administration of a drug in a health care setting or an outsourcing facility dispensing a drug pursuant to a properly executed prescription. (h) A compounded drug labeled “office use only” in accordance with subsection (e)(3)(vii) shall be administered in the office and not dispensed to the patient. (i) Notwithstanding the provisions of any general or special law to the contrary, the use of compounded medications in veterinary practice as defined in this section shall be exempt. (j) The board of registration in pharmacy shall have the power to enforce the provisions of this act. (k) The bureau of health professions licensure may promulgate rules and regulations necessary for the implementation and enforcement of this section.
If any provision of this act, or the application thereof to any person or circumstance, is held invalid, the remainder of the act and the application of such provision to other persons or circumstances shall not be affected thereby.
SECTION 1. Chapter 112 of the General Laws is hereby amended by inserting after section 297 the following section:- Section 298. (a) For the purposes of this section, the following words shall have the following meanings: "Compounded medication", a medication that is prepared, mixed, assembled, altered, or otherwise modified by a licensed pharmacist to meet the unique needs of an individual patient pursuant to a prescription. "Retail pharmacy", any establishment, including a community pharmacy, licensed by the state to dispense prescription medications directly to patients. "Resale", the selling, distributing, or otherwise transferring a medication that a retail pharmacy has purchased, in any quantity, to another entity or individual who is not the patient for whom the medication was originally compounded. (b) No retail pharmacy shall resell compounded medications, and compounded medications prepared by a retail pharmacy shall be dispensed only to the patient for whom the medication was originally compounded, pursuant to a valid prescription. (c) Any violation of subsection (b) of this section shall subject the retail pharmacy to disciplinary actions as determined by the board of registration in pharmacy, including, but not limited to fines, suspension, or revocation of the pharmacy's license. (d) The resale of a compounded drug that is labeled “not for resale” in accordance with subsection (b) of this section is prohibited. (e) In addition to the provisions described in section 21 of chapter 94C of the General Laws, the label of any drug compounded or repackaged by an outsourcing facility shall include, but not be limited to, the following: (1) the name, address, and phone number of the applicable outsourcing facility; and (2) with respect to the compounded drug: (i) the lot or batch number; (ii) the dosage form and strength; (iii) the statement of quantity or volume, as appropriate; (iv) the expiration date; (v) storage and handling instructions; (vi) the National Drug Code number, if available; (vii) the statement that the drug is not for resale, and if the drug product is distributed by an outsourcing facility other than pursuant to a prescription for an individual identified patient, the statement “office use only”; and (viii) a list of the active and inactive ingredients, identified by established name, and the quantity or proportion of each ingredient. (f) The container from which the individual units of the compounded drug are removed for dispensing or for administration, such as a plastic bag containing individual product syringes, shall include a list of active and inactive ingredients, identified by established name, and the quantity or proportion of each ingredient. (g) No compounded or repackaged drug will be sold or transferred by any entity other than the outsourcing facility that compounded or repackaged such drug. This does not prohibit the administration of a drug in a health care setting or an outsourcing facility dispensing a drug pursuant to a properly executed prescription. (h) A compounded drug labeled “office use only” in accordance with subsection (e)(3)(vii) shall be administered in the office and not dispensed to the patient. (i) Notwithstanding the provisions of any general or special law to the contrary, the use of compounded medications in veterinary practice as defined in this section shall be exempt. (j) The board of registration in pharmacy shall have the power to enforce the provisions of this act. (k) The bureau of health professions licensure may promulgate rules and regulations necessary for the implementation and enforcement of this section. SECTION 2. If any provision of this act, or the application thereof to any person or circumstance, is held invalid, the remainder of the act and the application of such provision to other persons or circumstances shall not be affected thereby.