Sec. 2. Traditional pharmacy compounding
1,825 words·~8 min read·
/bill/113/hr/3089/ih/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 503A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353a ) is amended to read as follows: Sections 501(a)(2)(B), 502(f)(1), and 505 of this Act and section 351 of the Public Health Service Act shall not apply to a drug product for human use if each of the following conditions is met: The drug product is compounded in accordance with one of the following: The drug product is compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician, for an identified individual patient based on the receipt of a valid prescription.
The drug product is compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician, in limited quantities before the receipt of a valid prescription for an identified individual patient, based on— historical demand for the drug product; and a history of prescriptions for the drug product generated solely within an established relationship between the licensed pharmacist or licensed physician who is performing the compounding and— the individual patient; or the physician or other licensed practitioner who writes the prescription.
The drug product is compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician, pursuant to a non-patient-specific purchase order and— the drug product will be administered by a health care practitioner within a physician’s office, a hospital, or another health care setting; valid patient-specific prescriptions or, when a compounded drug product is administered within the same health system in which it was compounded, valid patient names— are submitted, electronically or otherwise, to the pharmacist or physician who performs the compounding, not later than 7 business days after the drug product is administered; and will, in the aggregate, account for the total volume of drug product compounded pursuant to the non-patient-specific purchase order; during any 6-month period, of the total drug products dispensed from the facility at which the drug product was compounded, not more than 5 percent are compounded sterile drug products that are— dispensed pursuant to this subparagraph; and shipped interstate; records of the compounding will be kept for not less than 3 years; and the statement Office Use Only and the statement Not for resale appear on the compounded drug product.
Compounding under this subparagraph shall not be considered to be in violation of clause
(ii)because of the failure of a pharmacist or a physician to account for valid patient-specific prescriptions or valid patient names as required by such clause, so long as the pharmacist or physician makes a good faith, reasonable effort to account for the prescriptions or names, as applicable, and does not continue to compound drug products under this subparagraph for a health care practitioner or facility with a history of failing to submit such prescriptions or patient names. Irrespective of whether a drug product is compounded under subparagraph (A), (B), or
(C)of paragraph (1), the drug product is compounded, stored, and dated in compliance with the United States Pharmacopoeia chapters that are applicable to pharmaceutical compounding (including the chapter on sterile preparations). If the drug product is compounded using bulk drug substances (as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations (or any successor regulations))— the bulk drug substances— if an applicable monograph exists under the United States Pharmacopoeia, the National Formulary, or another compendium or pharmacopeia recognized under Federal law, each comply with the monograph; if such a monograph does not exist, each are drug substances that are components of drug products approved or licensed by the Secretary for human use; or if such a monograph does not exist and the drug substance is not a component of a drug product so approved or licensed, each appear on a list published by the Secretary (through regulations issued under subsection (e)); the bulk drug substances are each manufactured by an establishment that is registered under section 510 (including a foreign establishment that is registered under section 510(i)); and the bulk drug substances are each accompanied by a valid certificate of analysis. If any ingredients (other than bulk drug substances) are used in compounding the drug product, such ingredients comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph. The drug product does not appear on a list published by the Secretary of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The licensed pharmacist or licensed physician does not compound any drug product that is essentially a copy of a marketed and approved drug product. The drug product is not identified (directly or as part of a category of drug products) in a list published by the Secretary (through regulations issued under subsection (e)) as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. The drug product will not be sold by an entity other than the pharmacy or physician that compounded such drug product. Nothing in this section shall prevent a State from— imposing restrictions on the type of compounding described in subparagraph
(B)or
(C)of subsection (a)(1) that are in addition to the restrictions applicable under this section; or enforcing requirements or restrictions contained in the chapters or standards described in subsection (a)(2). The Secretary shall develop and implement a system for receiving and reviewing submissions from State boards of pharmacy— describing actions taken against compounding pharmacies; or expressing concerns that a compounding pharmacy may be acting in violation of one or more requirements of this section. An action referred to in paragraph (1)(A) is, with respect to a pharmacy that compounds drug products, any of the following: The issuance of a warning letter, or the imposition of sanctions or penalties, by a State for violations of a State’s pharmacy regulations pertaining to compounding. The suspension or revocation of a State-issued pharmacy license or registration. The recall of compounded drug products due to concerns relating to the quality or purity of such products. The Secretary shall develop the system under paragraph
(1)in consultation with the National Association of Boards of Pharmacy. The Secretary shall review each submission received under paragraph
(1)and such other information as the Secretary determines necessary (including information collected through an inspection or maintained in the Adverse Event Reporting System database) and make a determination as to whether the pharmacy involved may be in violation of one or more requirements of this section. The system under paragraph
(1)shall be designed to immediately notify State boards of pharmacy when— the Secretary receives a submission under paragraph (1); or the Secretary makes a determination that a pharmacy may be in violation of one or more requirements of this section. Not later than one year after the date of enactment of the Compounding Clarity Act of 2013 , the Secretary shall begin implementation of the system under paragraph (1). In accordance with section 704(a), the Secretary may inspect a pharmacy’s records to determine whether the pharmacy is in violation of one or more requirements of this Act if— the inspection is conducted in coordination with the relevant State board or boards of pharmacy; or the Secretary has evidence that the pharmacy may be in violation of such a requirement. The Secretary shall issue regulations to implement this section. Before issuing regulations to implement subsections (a)(3)(A)(iii) and (a)(7), the Secretary shall convene and consult an advisory committee on compounding. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacists having current experience and expertise in compounding, physicians having background and knowledge in compounding, and consumer organizations with an expertise in compounding. Before the date on which final regulations are issued to implement subsections (a)(3)(A)(iii) and (a)(7), if the Secretary determines it is necessary to protect the public health, the Secretary may designate drug products or substances as described in such subsections, by— publishing a notice of such drug products or substances proposed for designation, including the rationale for such designation, in the Federal Register; providing a period of not less than 60 calendar days for comment on the notice; and publishing a notice in the Federal Register designating such drug products or substances. The Secretary shall update the regulations containing the lists of drug products and substances described in subsections (a)(3)(A)(iii) and (a)(7) regularly, but not less than once every three years. Any notice published under paragraph
(3)shall not be effective after the earlier of— the date that is 3 years after the date of Compounding Clarity Act of 2013 ; and the effective date of the final regulations issued to implement subsections (a)(3)(A)(iii) and (a)(7). In this section: The term compounding includes— the combining, admixing, mixing, diluting, reconstituting, or otherwise altering of a marketed drug product, except when performed in accordance with specific directions for such acts contained in approved labeling provided by the product’s manufacturer or otherwise provided by that manufacturer consistent with that labeling; the combining, admixing, mixing, diluting, reconstituting, or otherwise altering a bulk drug substance to create a drug product; and repackaging. The term essentially a copy of a marketed and approved drug product does not include— a drug product in which there is a change, made for an identified individual patient, which produces for that patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug product and the comparable marketed and approved drug product; or a drug product that appears on the drug shortage list in effect under section 506E. The term licensed pharmacist includes any individual who compounds drug products under the supervision of a practitioner licensed to compound drug products under State law. The term marketed and approved drug product means a drug product that— is currently marketed; and is approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act. The term repackaging means taking a drug approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act from the container in which the drug is distributed by the original manufacturer and placing such drug in a different container of the same or smaller size without further manipulating the drug (such as by diluting it or mixing it with another, different drug or drugs). Such term does not include removing the drug from its original container for immediate administration to an identified individual patient, such as withdrawing a drug into a syringe for immediate injection or removing the drug from its original container within a health care entity by a practitioner, or other licensed individual under the supervision or direction of such practitioner, for administration within the same day within such health care entity. .
Connectionstraces to 1
Traces to 1 document
U.S. Code
Citation graph
cites case law
Sec. 2
Traditional pharmacy compounding
Cites 1Cited by 0 across 0 sources