2023 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.