21 U.S.C. § 353a — Pharmacy compounding

Page 177 TITLE 21—FOOD AND DRUGS § 353a ceiving new precriptions [sic] by the year 2000 and to 95 percent by the year 2006. ‘‘(c) PLAN.—The plan described in subsection (a) shall— ‘‘(1) identify the plan goals; ‘‘(2) assess the effectiveness of the current private- sector approaches used to provide oral and written prescription information to consumers; ‘‘(3) develop guidelines for providing effective oral and written prescription information consistent with the findings of any such assessment; ‘‘(4) contain elements necessary to ensure the transmittal of useful information to the consuming public, including being scientifically accurate, non- promotional in tone and content, sufficiently specific and comprehensive as to adequately inform con- sumers about the use of the product, and in an under- standable, legible format that is readily comprehen- sible and not confusing to consumers expected to use the product.[;] ‘‘(5) develop a mechanism to assess periodically the quality of the oral and written prescription informa- tion and the frequency with which the information is provided to consumers; and ‘‘(6) provide for compliance with relevant State board regulations. ‘‘(d) LIMITATION ON THE AUTHORITY OF THE SEC- RETARY.—The Secretary of the Department of Health and Human Services shall have no authority to imple- ment the proposed rule described in subsection (a), or to develop any similar regulation, policy statement, or other guideline specifying a uniform content or format for written information voluntarily provided to con- sumers about prescription drugs if, (1) not later than 120 days after the date of enactment of this Act [Aug. 6, 1996], the national organizations described in sub- section (a) develop and submit to the Secretary for Health and Human Services a comprehensive, long- range action plan (as described in subsection (a)) which shall be acceptable to the Secretary of Health and Human Services; (2) the aforementioned plan is sub- mitted to the Secretary of Health and Human Services for review and acceptance: Provided, That the Secretary shall give due consideration to the submitted plan and that any such acceptance shall not be arbitrarily with- held; and (3) the implementation of (a) a plan accepted by the Secretary commences within 30 days of the Sec- retary’s acceptance of such plan, or (b) the plan sub- mitted to the Secretary commences within 60 days of the submission of such plan if the Secretary fails to take any action on the plan within 30 days of the sub- mission of the plan. The Secretary shall accept, reject or suggest modifications to the plan submitted within 30 days of its submission. The Secretary may confer with and assist private parties in the development of the plan described in subsections (a) and (b). ‘‘(e) SECRETARY REVIEW.—Not later than January 1, 2001, the Secretary of the Department of Health and Human Services shall review the status of private-sec- tor initiatives designed to achieve the goals of the plan described in subsection (a), and if such goals are not achieved, the limitation in subsection (d) shall not apply, and the Secretary shall seek public comment on other initiatives that may be carried out to meet such goals.’’ CONGRESSIONAL FINDINGS Pub. L. 100–293, § 2, Apr. 22, 1988, 102 Stat. 95, provided that: ‘‘The Congress finds the following: ‘‘(1) American consumers cannot purchase prescrip- tion drugs with the certainty that the products are safe and effective. ‘‘(2) The integrity of the distribution system for prescription drugs is insufficient to prevent the intro- duction and eventual retail sale of substandard, inef- fective, or even counterfeit drugs. ‘‘(3) The existence and operation of a wholesale sub- market, commonly known as the ‘diversion market’, prevents effective control over or even routine knowledge of the true sources of prescription drugs in a significant number of cases. ‘‘(4) Large amounts of drugs are being reimported to the United States as American goods returned. These imports are a health and safety risk to Amer- ican consumers because they may have become sub- potent or adulterated during foreign handling and shipping. ‘‘(5) The ready market for prescription drug re- imports has been the catalyst for a continuing series of frauds against American manufacturers and has provided the cover for the importation of foreign counterfeit drugs. ‘‘(6) The existing system of providing drug samples to physicians through manufacturer’s representatives has been abused for decades and has resulted in the sale to consumers of misbranded, expired, and adul- terated pharmaceuticals. ‘‘(7) The bulk resale of below wholesale priced pre- scription drugs by health care entities, for ultimate sale at retail, helps fuel the diversion market and is an unfair form of competition to wholesalers and re- tailers that must pay otherwise prevailing market prices. ‘‘(8) The effect of these several practices and condi- tions is to create an unacceptable risk that counter- feit, adulterated, misbranded, subpotent, or expired drugs will be sold to American consumers.’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 353a. Pharmacy compounding (a) In general Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified in- dividual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding— (1) is by— (A) a licensed pharmacist in a State li- censed pharmacy or a Federal facility, or (B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or (2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the re- ceipt of a valid prescription order for such in- dividual patient; and (B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established rela- tionship between— (i) the licensed pharmacist or licensed phy- sician; and (ii)(I) such individual patient for whom the prescription order will be provided; or (II) the physician or other licensed practi- tioner who will write such prescription order. Page 178 TITLE 21—FOOD AND DRUGS § 353a (b) Compounded drug (1) Licensed pharmacist and licensed physician A drug product may be compounded under subsection (a) if the licensed pharmacist or li- censed physician— (A) compounds the drug product using bulk drug substances, as defined in regula- tions of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations— (i) that— (I) comply with the standards of an ap- plicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding; (II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or (III) if such a monograph does not exist and the drug substance is not a compo- nent of a drug approved by the Sec- retary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (c); (ii) that are manufactured by an estab- lishment that is registered under section 360 of this title (including a foreign estab- lishment that is registered under section 360(i) of this title); and (iii) that are accompanied by valid cer- tificates of analysis for each bulk drug substance; (B) compounds the drug product using in- gredients (other than bulk drug substances) that comply with the standards of an appli- cable United States Pharmacopoeia or Na- tional Formulary monograph, if a mono- graph exists, and the United States Pharma- copoeia chapter on pharmacy compounding; (C) does not compound a drug product that appears on a list published by the Secretary in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or com- ponents of such drug products have been found to be unsafe or not effective; and (D) does not compound regularly or in in- ordinate amounts (as defined by the Sec- retary) any drug products that are essen- tially copies of a commercially available drug product. (2) Definition For purposes of paragraph (1)(D), the term ‘‘essentially a copy of a commercially avail- able drug product’’ does not include a drug product in which there is a change, made for an identified individual patient, which pro- duces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the com- parable commercially available drug product. (3) Drug product A drug product may be compounded under subsection (a) only if— (A) such drug product is not a drug prod- uct identified by the Secretary by regulation as a drug product that presents demon- strable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug prod- uct; and (B) such drug product is compounded in a State— (i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate in- vestigation by a State agency of com- plaints relating to compounded drug prod- ucts distributed outside such State; or (ii) that has not entered into the memo- randum of understanding described in clause (i) and the licensed pharmacist, li- censed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physi- cian. The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of under- standing for use by the States in complying with subparagraph (B)(i). (c) Regulations (1) In general The Secretary shall issue regulations to im- plement this section. Before issuing regula- tions to implement subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Sec- retary shall convene and consult an advisory committee on compounding unless the Sec- retary determines that the issuance of such regulations before consultation is necessary to protect the public health. The advisory com- mittee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy, physician, and consumer organizations, and other experts selected by the Secretary. (2) Limiting compounding The Secretary, in consultation with the United States Pharmacopoeia Convention, In- corporated, shall promulgate regulations iden- tifying drug substances that may be used in compounding under subsection (b)(1)(A)(i)(III) for which a monograph does not exist or which are not components of drug products approved by the Secretary. The Secretary shall include in the regulation the criteria for such sub- stances, which shall include historical use, re- ports in peer reviewed medical literature, or other criteria the Secretary may identify. (d) Application This section shall not apply to— (1) compounded positron emission tomog- raphy drugs as defined in section 321(ii) of this title; or (2) radiopharmaceuticals. (e) ‘‘Compounding’’ defined As used in this section, the term ‘‘compounding’’ does not include mixing, recon- Page 179 TITLE 21—FOOD AND DRUGS § 353b stituting, or other such acts that are performed in accordance with directions contained in ap- proved labeling provided by the product’s manu- facturer and other manufacturer directions con- sistent with that labeling. (June 25, 1938, ch. 675, § 503A, as added Pub. L. 105–115, title I, § 127(a), Nov. 21, 1997, 111 Stat. 2328; amended Pub. L. 113–54, title I, § 106(a), Nov. 27, 2013, 127 Stat. 598.) Editorial Notes AMENDMENTS 2013—Subsec. (a). Pub. L. 113–54, § 106(a)(1), struck out ‘‘unsolicited’’ before ‘‘receipt of a valid prescription’’ in introductory provisions. Subsec. (b)(1)(A)(i)(III). Pub. L. 113–54, § 106(a)(4), sub- stituted ‘‘subsection (c)’’ for ‘‘subsection (d)’’. Subsecs. (c) to (f). Pub. L. 113–54, § 106(a)(2), (3), redes- ignated subsecs. (d) to (f) as (c) to (e), respectively, and struck out former subsec. (c). Prior to amendment, sub- sec. (c) read as follows: ‘‘A drug may be compounded under subsection (a) of this section only if the phar- macy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any par- ticular drug, class of drug, or type of drug. The phar- macy, licensed pharmacist, or licensed physician may advertise and promote the compounding service pro- vided by the licensed pharmacist or licensed physi- cian.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE Pub. L. 105–115, title I, § 127(b), Nov. 21, 1997, 111 Stat. 2330, provided that: ‘‘Section 503A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by sub- section (a), shall take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act [Nov. 21, 1997].’’ § 353a–1. Enhanced communication (a) Submissions from State boards of pharmacy In a manner specified by the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), the Secretary shall receive submissions from State boards of phar- macy— (1) describing actions taken against compounding pharmacies, as described in sub- section (b); or (2) expressing concerns that a compounding pharmacy may be acting contrary to section 353a of this title. (b) Content of submissions from State boards of pharmacy An action referred to in subsection (a)(1) is, with respect to a pharmacy that compounds drugs, any of the following: (1) The issuance of a warning letter, or the imposition of sanctions or penalties, by a State for violations of a State’s pharmacy reg- ulations pertaining to compounding. (2) The suspension or revocation of a State- issued pharmacy license or registration for violations of a State’s pharmacy regulations pertaining to compounding. (3) The recall of a compounded drug due to concerns relating to the quality or purity of such drug. (c) Consultation The Secretary shall implement subsection (a) in consultation with the National Association of Boards of Pharmacy. (d) Notifying State boards of pharmacy The Secretary shall immediately notify State boards of pharmacy when— (1) the Secretary receives a submission under subsection (a)(1); or (2) the Secretary makes a determination that a pharmacy is acting contrary to section 353a of this title. (Pub. L. 113–54, title I, § 105, Nov. 27, 2013, 127 Stat. 597.) Editorial Notes CODIFICATION Section was enacted as part of the Compounding Quality Act and also as part of the Drug Quality and Security Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter. § 353b. Outsourcing facilities (a) In general Sections 352(f)(1), 355, and 360eee–1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed phar- macist in a facility that elects to register as an outsourcing facility if each of the following con- ditions is met: (1) Registration and reporting The drug is compounded in an outsourcing facility that is in compliance with the require- ments of subsection (b). (2) Bulk drug substances The drug is compounded in an outsourcing facility that does not compound using bulk drug substances (as defined in section 207.3(a)(4) of title 21, Code of Federal Regula- tions (or any successor regulation)), unless— (A)(i) the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need, by— (I) publishing a notice in the Federal Register proposing bulk drug substances to be included on the list, including the ra- tionale for such proposal; (II) providing a period of not less than 60 calendar days for comment on the notice; and (III) publishing a notice in the Federal Register designating bulk drug substances for inclusion on the list; or (ii) the drug compounded from such bulk drug substance appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing; (B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compen- dium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph; (C) the bulk drug substances are each man- ufactured by an establishment that is reg- istered under section 360 of this title (includ- ing a foreign establishment that is reg- istered under section 360(i) of this title); and