§ 6831 — Special provisions relating to outsourcing facilities

§ 6831. Special provisions relating to outsourcing facilities. 1.\nRegistration. Any outsourcing facility that is engaged in the\ncompounding of sterile drugs in this state shall be registered as an\noutsourcing facility under the Federal Food, Drug and Cosmetic Act and\nbe registered as an outsourcing facility pursuant to this article.\n 2. New drugs. Sections 502(f)(1), 505 and 582 of the Federal Food,\nDrug and Cosmetic Act shall not apply to a drug compounded in an\noutsourcing facility registered under the Federal Food, Drug and\nCosmetic Act.\n 3. Prescriptions. Notwithstanding any other provision of law to the\ncontrary, no outsourcing facility may distribute or dispense any drug to\nany person pursuant to a prescription unless it is also registered as a\npharmacy in this state and meets all other applicable requirements of\nfederal and state law.\n 4. Restrictions. Any drugs compounded in an outsourcing facility\nregistered pursuant to this article shall be compounded in accordance\nwith all applicable federal and state laws.\n 5. Labeling. Notwithstanding any other provision of law to the\ncontrary, the label of any drug compounded by an outsourcing facility\nshall include, but not be limited to the following:\n (a) a statement that the drug is a compounded drug or a reasonable\ncomparable alternative statement that prominently identifies the drug as\na compounded drug;\n (b) the name, address, and phone number of the applicable outsourcing\nfacility; and\n (c) with respect to the drug:\n (i) the lot or batch number;\n (ii) the established name of the drug;\n (iii) the dosage form and strength;\n (iv) the statement of quantity or volume, as appropriate;\n (v) the date that the drug was compounded;\n (vi) the expiration date;\n (vii) storage and handling instructions;\n (viii) the National Drug Code number, if available;\n (ix) the statement that the drug is not for resale, and the statement\n"Office Use Only"; and\n (x) a list of the active and inactive ingredients, identified by\nestablished name, and the quantity or proportion of each ingredient.\n 6. Container. The container from which the individual units of the\ndrug are removed for dispensing or for administration (such as a plastic\nbag containing individual product syringes) shall include:\n (a) a list of active and inactive ingredients, identified by\nestablished name, and the quantity or proportion of each ingredient; and\n (b) any other information required by regulations promulgated by the\ncommissioner to facilitate adverse event reporting in accordance with\nthe requirements established in section 310.305 of title 21 of the code\nof federal regulations.\n 7. Bulk drugs. A drug may only be compounded in an outsourcing\nfacility that does not compound using bulk drug substances as defined in\nsection 207.3(a)(4) of title 21 of the code of federal regulations or\nany successor regulation unless:\n (a) the bulk drug substance appears on a list established by the\nsecretary of health and human services identifying bulk drug substances\nfor which there is a clinical need;\n (b) the drug is compounded from a bulk drug substance that appears on\nthe federal drug shortage list in effect at the time of compounding,\ndistributing, and dispensing;\n (c) if an applicable monograph exists under the United States\nPharmacopeia, the national formulary, or another compendium or\npharmacopeia recognized by the secretary of health and human services\nand the bulk drug substances each comply with the monograph;\n (d) the bulk drug substances are each manufactured by an establishment\nthat is registered with the federal government.\n 8. Ingredients. If an outsourcing facility uses ingredients, other\nthan bulk drug substances, such ingredients must comply with the\nstandards of the applicable United States pharmacopeia or national\nformulary monograph, if such monograph exists, or of another compendium\nor pharmacopeia recognized by the secretary of health and human services\nfor purposes of this subdivision, if any.\n 9. Unsafe or ineffective drugs. No outsourcing facility may compound a\ndrug that appears on a list published by the secretary of health and\nhuman services that has been withdrawn or removed from the market\nbecause such drugs or components of such drugs have been found to be\nunsafe or not effective.\n 10. Prohibition on wholesaling. No compounded drug will be sold or\ntransferred by any entity other than the outsourcing facility that\ncompounded such drug. This does not prohibit the administration of a\ndrug in a health care setting or dispensing a drug pursuant to a\nproperly executed prescription.\n 11. Prohibition against copying an approved drug. No outsourcing\nfacility may compound a drug that is essentially a copy of one or more\napproved drugs.\n 12. Prohibition against compounding drugs presenting demonstrable\ndifficulties. No outsourcing facility may compound a drug:\n i. that is identified, directly or as part of a category of drugs, on\na list published by the secretary of health and human services that\npresent demonstrable difficulties for compounding that are reasonably\nlikely to lead to an adverse effect on the safety or effectiveness of\nthe drug or category of drugs, taking into account the risks and\nbenefits to patients; or\n ii. that is compounded in accordance with all applicable conditions\nidentified on the drug list as conditions that are necessary to prevent\nthe drug or category of drugs from presenting demonstrable difficulties.\n 13. Adverse event reports. Outsourcing facilities shall submit a copy\nof all adverse event reports submitted to the secretary of health and\nhuman services in accordance with the content and format requirements\nestablished in section 310.305 of title 21 of the code of federal\nregulations, or any successor regulation, to the executive secretary for\nthe state board of pharmacy.\n 14. Reports. The commissioner, in consultation with the commissioner\nof health, shall prepare and submit a report to the governor and the\nlegislature, due eighteen months from the effective date of this\nsection, evaluating the effectiveness of the registration and oversight\nof outsourcing facilities related to compounding.\n