Preserving Patient Access to Compounded Medications Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 1959 To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 28, 2019 Mr. GRIFFITH (for himself and Mr. CUELLAR) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Preserving Patient Ac- 4 cess to Compounded Medications Act of 2019’’. 5 SEC. 2. OFFICE-USE COMPOUNDING WHEN AUTHORIZED BY 6 STATE LAW. 7 Section 503A(a) of the Federal Food, Drug, and Cos- 8 metic Act (21 U.S.C. 353a(a)) is amended— 9 VerDate Sep 11 2014 04:42 Apr 11, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1959.IH H1959 kjohnson on DSK79L0C42 with BILLS 2 •HR 1959 IH (1) in the matter preceding paragraph (1), by 1 inserting ‘‘or drug order for administration to a pa- 2 tient in an office or clinical setting’’ after ‘‘is nec- 3 essary for the identified patient’’; 4 (2) in paragraph (1), by striking ‘‘or’’ at the 5 end; 6 (3) in paragraph (2), by striking the period at 7 the end and inserting ‘‘; or’’; and 8 (4) by adding at the end the following new 9 paragraph: 10 ‘‘(3) is by a licensed pharmacist or licensed 11 physician pursuant to a valid prescription order or 12 drug order and the compounded drug is distributed 13 or dispensed to a licensed prescriber in accordance 14 with State law, for administration to a patient in an 15 office or clinical setting.’’. 16 SEC. 3. UNITED STATES PHARMACOPOEIA OR NATIONAL 17 FORMULARY MONOGRAPH REQUIREMENT. 18 Section 503A(b)(1)(A) of the Federal Food, Drug, 19 and Cosmetic Act (21 U.S.C. 353A(b)(1)(A)) is amend- 20 ed— 21 (1) in the matter preceding subclause (i), by in- 22 serting ‘‘, or dietary supplements’’ after ‘‘Regula- 23 tions’’; and 24 (2) in clause (i)— 25 VerDate Sep 11 2014 04:42 Apr 11, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1959.IH H1959 kjohnson on DSK79L0C42 with BILLS 3 •HR 1959 IH (A) by amending subclause (I) to read as 1 follows: 2 ‘‘(I) comply with the monograph 3 standards in any section of the United 4 States Pharmacopoeia or National 5 Formulary, including drug substance 6 or dietary supplement monograph, if a 7 monograph exists.’’; and 8 (B) by amending subclause (III) to read as 9 follows: 10 ‘‘(III) if such monograph does 11 not exist and the drug substance or 12 dietary supplement is not a compo- 13 nent of a drug approved by the Sec- 14 retary, but appears on a list developed 15 by the Secretary through regulations 16 issued by the Secretary under sub- 17 section (c) of this section;’’. 18 SEC. 4. DEFINITIONS. 19 Subsection (e) of section 503A of the Federal Food, 20 Drug, and Cosmetic Act (21 U.S.C. 353a) is amended to 21 read as follows: 22 ‘‘(e) DEFINITIONS.—In this section: 23 ‘‘(1) COMPOUNDING.—The term ‘compounding’ 24 does not include mixing, reconstituting, or other 25 VerDate Sep 11 2014 04:42 Apr 11, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1959.IH H1959 kjohnson on DSK79L0C42 with BILLS 4 •HR 1959 IH such acts that are performed in accordance with di- 1 rections contained in approved labeling provided by 2 the product’s manufacturer and other manufacturer 3 directions consistent with that labeling. 4 ‘‘(2) DISTRIBUTE OR DISTRIBUTION.—The 5 terms ‘distribute’ or ‘distribution’ do not include the 6 act of dispensing of a compounded drug product in 7 accordance with this section. 8 ‘‘(3) DISPENSE.—The term ‘dispense’ means 9 for a drug product compounded in accordance with 10 this section, the act of the drug product leaving the 11 facility in which it was compounded for delivery to 12 a patient, patient’s agent, or health care facility (in- 13 cluding a hospital, physician’s office, or other health 14 care setting) pursuant to a valid prescription order 15 for an identified patient.’’. 16 SEC. 5. APPLICABILITY OF RECORDS EXEMPTION FOR 17 COMPOUNDING PHARMACIES. 18 (a) IN GENERAL.—Section 704(a)(2)(A) of the Fed- 19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 20 374(a)(2)(A)) is amended to read as follows: 21 ‘‘(A) pharmacies which maintain establish- 22 ments in conformance with any applicable local 23 laws regulating the practice of pharmacy and 24 medicine and, for compounding pharmacies, the 25 VerDate Sep 11 2014 04:42 Apr 11, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1959.IH H1959 kjohnson on DSK79L0C42 with BILLS 5 •HR 1959 IH provisions of section 503A, and which are regu- 1 larly engaged in dispensing or distributing pre- 2 scription drugs or devices, upon prescriptions or 3 drug orders of practitioners licensed to admin- 4 ister such drugs or devices to patients under 5 the care of such practitioners in the course of 6 their professional practice, and which do not, ei- 7 ther through a subsidiary or otherwise, manu- 8 facture, prepare, propagate, compound, or proc- 9 ess drugs or devices for sale other than in the 10 regular course of their business;’’. 11 (b) REGISTRATION EXEMPTION.—Section 510(g)(1) 12 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 13 360(g)(1)) is amended to read as follows: 14 ‘‘(1) pharmacies which maintain establishments 15 in conformance with any applicable local laws regu- 16 lating the practice of pharmacy and medicine and, 17 for compounding pharmacies, the provisions of sec- 18 tion 503A, and which are regularly engaged in dis- 19 pensing or distributing prescription drugs or devices, 20 upon prescriptions or drug orders of practitioners li- 21 censed to administer such drugs or devices to pa- 22 tients under the care of such practitioners in the 23 course of their professional practice, and which do 24 not manufacture, prepare, propagate, compound, or 25 VerDate Sep 11 2014 04:42 Apr 11, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1959.IH H1959 kjohnson on DSK79L0C42 with BILLS 6 •HR 1959 IH process drugs or devices for sale other than in the 1 regular course of their business;’’. 2 SEC. 6. REGULATIONS. 3 (a) RULES IMPLEMENTING NEW REQUIREMENTS.— 4 Not later than 90 days after the date of enactment of this 5 Act, the Secretary of Health and Human Services shall 6 promulgate rules on the record to carry out the amend- 7 ments made by this Act, in accordance with chapter 5 of 8 title 5, United States Code. 9 (b) OTHER RULES.—The Secretary of Health and 10 Human Services shall promulgate rules on the record to 11 carry out any of the provisions of section 503A of the Fed- 12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 353a) 13 other than those amended by this Act, in accordance with 14 chapter 5 of title 5, United States Code. 15 Æ VerDate Sep 11 2014 04:42 Apr 11, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H1959.IH H1959 kjohnson on DSK79L0C42 with BILLS