NY Educ L § 6831 (2021)
2021 New York Laws EDN - Education Title 8 - The Professions Article 137 - Pharmacy 6831 - Special Provisions Relating to Outsourcing Facilities.

§  6831.  Special  provisions  relating  to outsourcing facilities. 1. Registration.  Any  outsourcing  facility  that  is   engaged   in   the compounding  of  sterile  drugs  in this state shall be registered as an outsourcing facility under the Federal Food, Drug and Cosmetic  Act  and be registered as an outsourcing facility pursuant to this article.   2.  New  drugs.  Sections  502(f)(1), 505 and 582 of the Federal Food, Drug and Cosmetic Act shall  not  apply  to  a  drug  compounded  in  an outsourcing  facility  registered  under  the  Federal  Food,  Drug  and Cosmetic Act.   3. Prescriptions. Notwithstanding any other provision of  law  to  the contrary, no outsourcing facility may distribute or dispense any drug to any  person pursuant to a prescription unless it is also registered as a pharmacy in this state and meets all other  applicable  requirements  of federal and state law.   4.  Restrictions.  Any  drugs  compounded  in  an outsourcing facility registered pursuant to this article shall be  compounded  in  accordance with all applicable federal and state laws.   5.  Labeling.  Notwithstanding  any  other  provision  of  law  to the contrary, the label of any drug compounded by  an  outsourcing  facility shall include, but not be limited to the following:  (a)  a  statement  that  the drug is a compounded drug or a reasonable comparable alternative statement that prominently identifies the drug as a compounded drug;  (b) the name, address, and phone number of the applicable  outsourcing facility; and  (c) with respect to the drug:  (i) the lot or batch number;  (ii) the established name of the drug;  (iii) the dosage form and strength;  (iv) the statement of quantity or volume, as appropriate;  (v) the date that the drug was compounded;  (vi) the expiration date;  (vii) storage and handling instructions;  (viii) the National Drug Code number, if available;  (ix)  the statement that the drug is not for resale, and the statement "Office Use Only"; and  (x) a list of the  active  and  inactive  ingredients,  identified  by established name, and the quantity or proportion of each ingredient.   6.  Container.  The  container  from which the individual units of the drug are removed for dispensing or for administration (such as a plastic bag containing individual product syringes) shall include:  (a)  a  list  of  active  and  inactive  ingredients,  identified   by established name, and the quantity or proportion of each ingredient; and  (b)  any  other information required by regulations promulgated by the commissioner to facilitate adverse event reporting  in  accordance  with the  requirements established in section 310.305 of title 21 of the code of federal regulations.   7. Bulk drugs. A  drug  may  only  be  compounded  in  an  outsourcing facility that does not compound using bulk drug substances as defined in section  207.3(a)(4)  of  title 21 of the code of federal regulations or any successor regulation unless:  (a) the bulk drug substance appears  on  a  list  established  by  the secretary  of health and human services identifying bulk drug substances for which there is a clinical need;  (b) the drug is compounded from a bulk drug substance that appears  on the  federal  drug  shortage  list in effect at the time of compounding, distributing, and dispensing;  (c)  if  an  applicable  monograph  exists  under  the  United  States Pharmacopeia,   the   national   formulary,  or  another  compendium  or pharmacopeia recognized by the secretary of health  and  human  services and the bulk drug substances each comply with the monograph;  (d) the bulk drug substances are each manufactured by an establishment that is registered with the federal government.   8.  Ingredients.  If  an  outsourcing facility uses ingredients, other than bulk  drug  substances,  such  ingredients  must  comply  with  the standards  of  the  applicable  United  States  pharmacopeia or national formulary monograph, if such monograph exists, or of another  compendium or pharmacopeia recognized by the secretary of health and human services for purposes of this subdivision, if any.   9. Unsafe or ineffective drugs. No outsourcing facility may compound a drug  that  appears  on  a list published by the secretary of health and human services that has  been  withdrawn  or  removed  from  the  market because  such  drugs  or  components of such drugs have been found to be unsafe or not effective.   10. Prohibition on wholesaling. No compounded drug  will  be  sold  or transferred  by  any  entity  other  than  the outsourcing facility that compounded such drug. This does not prohibit  the  administration  of  a drug  in  a  health  care  setting  or  dispensing  a drug pursuant to a properly executed prescription.   11. Prohibition against  copying  an  approved  drug.  No  outsourcing facility  may  compound a drug that is essentially a copy of one or more approved drugs.   12. Prohibition  against  compounding  drugs  presenting  demonstrable difficulties. No outsourcing facility may compound a drug:   i.  that is identified, directly or as part of a category of drugs, on a list published by the secretary of  health  and  human  services  that present  demonstrable  difficulties  for compounding that are reasonably likely to lead to an adverse effect on the safety  or  effectiveness  of the  drug  or  category  of  drugs,  taking  into  account the risks and benefits to patients; or   ii. that is compounded in accordance with  all  applicable  conditions identified  on the drug list as conditions that are necessary to prevent the drug or category of drugs from presenting demonstrable difficulties.   13. Adverse event reports. Outsourcing facilities shall submit a  copy of  all  adverse  event reports submitted to the secretary of health and human services in accordance with the content  and  format  requirements established  in  section  310.305  of  title  21  of the code of federal regulations, or any successor regulation, to the executive secretary for the state board of pharmacy.   14. Reports. The commissioner, in consultation with  the  commissioner of  health,  shall  prepare  and submit a report to the governor and the legislature, due  eighteen  months  from  the  effective  date  of  this section,  evaluating the effectiveness of the registration and oversight of outsourcing facilities related to compounding.