,i #aafth ,,congress #ast ,session ,h4 ,r4 #aiei ,,in ,,the ,,house ,,of ,,representatives ,march #bh1 #bjai ,mr4 ,griffith 7for himself and ,mr4 ,cuellar7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to compounding pharmacies1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,preserving ,patient ,access to ,compounded ,medications ,act of #bjai4 #b4 ,office-use compounding when authorized by ,state law ,section #ejc;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by inserting or drug order for administration to a patient in an office or clinical setting after is necessary for the identified patient2 7#b7 in paragraph 7#a71 by striking or at the end2 7#c7 in paragraph 7#b71 by striking the period at the end and inserting 2 or2 and 7#d7 by adding at the end the following new paragraph3 7#c7 is by a licensed pharmacist or licensed physician pursuant to a valid prescription order or drug order and the compounded drug is distributed or dispensed to a licensed prescriber in accordance with ,state law1 for administration to a patient in an office or clinical setting4 4 #c4 ,united ,states pharmacopoeia or national formulary monograph requirement ,section #ejc;,a7b77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;,a7b77#a77;,a77 is amended-- 7#a7 in the matter preceding subclause 7i71 by inserting 1 or dietary supplements after ,regulations2 and 7#b7 in clause 7i7-- 7,a7 by amending subclause 7,i7 to read as follows3 7,i7 comply with the monograph standards in any section of the ,united ,states ,pharmacopoeia or ,national ,formulary1 including drug substance or dietary supplement monograph1 if a monograph exists4 2 and 7,b7 by amending subclause 7,,iii7 to read as follows3 7,,iii7 if such monograph does not exist and the drug substance or dietary supplement is not a component of a drug approved by the ,secretary1 but appears on a list developed by the ,secretary through regulations issued by the ,secretary under subsection 7c7 of this section2 4 #d4 ,definitions ,subsection 7e7 of section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is amended to read as follows3 7e7 ,definitions ,in this section3 7#a7 ,compounding ,the term compounding does not include mixing1 reconstituting1 or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling4 7#b7 ,distribute or distribution ,the terms distribute or distribution do not include the act of dispensing of a compounded drug product in accordance with this section4 7#c7 ,dispense ,the term dispense means for a drug product compounded in accordance with this section1 the act of the drug product leaving the facility in which it was compounded for delivery to a patient1 patient's agent1 or health care facility 7including a hospital1 physician's office1 or other health care setting7 pursuant to a valid prescription order for an identified patient4 4 #e4 ,applicability of records exemption for compounding pharmacies 7a7 ,in general ,section #gjd7;a77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#b77;,a77 is amended to read as follows3 7,a7 pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and1 for compounding pharmacies1 the provisions of section #ejc;,a1 and which are regularly engaged in dispensing or distributing prescription drugs or devices1 upon prescriptions or drug orders of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice1 and which do not1 either through a subsidiary or otherwise1 manufacture1 prepare1 propagate1 compound1 or process drugs or devices for sale other than in the regular course of their business2 4 7b7 ,registration exemption ,section #eaj7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;g77#a77 is amended to read as follows3 7#a7 pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and1 for compounding pharmacies1 the provisions of section #ejc;,a1 and which are regularly engaged in dispensing or distributing prescription drugs or devices1 upon prescriptions or drug orders of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice1 and which do not manufacture1 prepare1 propagate1 compound1 or process drugs or devices for sale other than in the regular course of their business2 4 #f4 ,regulations 7a7 ,rules implementing new requirements ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate rules on the record to carry out the amendments made by this ,act1 in accordance with chapter #e of title #e1 ,united ,states ,code4 7b7 ,other rules ,the ,secretary of ,health and ,human ,services shall promulgate rules on the record to carry out any of the provisions of section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 other than those amended by this ,act1 in accordance with chapter #e of title #e1 ,united ,states ,code4