USP 800: State-by-state

AL USP 800 Rules: 680-X-2-.43 Requirements For Compounding. All pharmacies that engage in the compounding of drugs or drug products shall comply with all applicable and current regulations of United States Pharmacopeia–National Formulary (USP)-NF. Section 34-23-11 applies; effective September 8, 2018.

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AL USP 800 / USP 797 referene

AK USP 800 Rules:

Notes: According to the Board of Pharmacy executive administrator, these have been on the board's radar for awhile. Board is hoping to meet and discuss how to proceed before December. The last few board meetings were canceled.

AK USP 800 / USP 797 referene

AZ USP 800 Rules: R4-23-410. Current Good Compounding Practices A. This Section establishes the current good compounding practices to be used by a pharmacist licensed by the Board, in a pharmacy permitted by the Board, and in compliance with applicable federal and state law governing the practice of pharmacy. B. A pharmacy permittee shall ensure compliance with the provisions in this subsection. 1. All substances for compounding that are received, stored, or used by the pharmacy permittee: a. Meet official compendium requirements Amended by final rulemaking at 12 A.A.R. 3981, effective December 4, 2006 (Supp. 06-4)

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AZ USP 800 / USP 797 referene

AR USP 800 Rules:

Notes: According to the Board of Pharmacy director, he cannot say if they would be adopted or when.

AR USP 800 / USP 797 referene

CA USP 800 Rules: California has numerous components of USP compounding standards throughout its rules (too numerous to list here). Click on website link for rules. See also "Notes" column for how the board plans to move forward making USP more consistent in California rules.

Notes: The Board of Pharmacy is planning to implement a hybrid approval process for USP. The board introduced a bill (AB 973) so that changes made by USP to 795, 797, and 800 are automatically incorporated into the pharmacy regulations. The legislation still allows the board to add additional standards /requirements if they feel it's necessary. AB 973 passed the Assembly and is now in the Senate. Board staff is currently doing a gap analysis of the USP chapters and other regs. If board find gaps that need to be filled in, the board will propose regulations to do so. It is the board's Compounding Committee’s intention to continue its efforts to evaluate regulations necessary to ensure safe compounding practices consistent with the board’s consumer protection mandate. The timing of board regulations will be determined after additional information is provided by USP. The board will be assessing the implications for USP 800 and conferring with other state regulators, as well as assessing the issue as information is provided by USP. Changes will be posted on the board’s website under “What’s New” and sent to facilities via subscriber alerts.

CA USP 800 / USP 797 referene

PR USP 800 Rules:

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PR USP 800 / USP 797 referene

CO USP 800 Rules:

Notes: The Board of Pharmacy expressed interest in incorporating USP 795, 797, 800, and 825 by reference earlier this year, though it has yet to incorporate any USP chapters in whole or by reference, according to the board’s program director. The board will be hosting a stakeholder meeting to collect feedback regarding this in mid-October. The compounding rules may be based in part on USP standards. The timeframe is based on the rule-making process. At this time, if the board were to adopt the new rules, they most likely would not go into effect until the first part of 2020.

CO USP 800 / USP 797 referene

CT USP 800 Rules: (18) “Official compendium” means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them See Sec. 20-633b. Sterile compounding pharmacies. Requirements. Regulations and Sec. 20-579 Causes for suspension, revocation, etc. for mentions of 795 & 797. History: P.A. 14-224 effective July 1, 2014; P.A. 17-77 amended Subsec. (a)(2) by replacing “section 20-594, or” with “section 20-571,”, effective July 1, 2017; P.A. 18-16 amended Subsec. (c) by replacing “most recent United States Pharmacopeia, Chapter 797,” with “most recent version of the United States Pharmacopeia,”, effective January 1, 2019.

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CT USP 800 / USP 797 referene

DC USP 800 Rules:

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DC USP 800 / USP 797 referene

DE USP 800 Rules: 10.0 Pharmaceutical Compounding All individuals and entities licensed by the Delaware Board of Pharmacy engaged in compounding shall adhere to and comply with both the current edition of the United States Pharmacopeia Chapters 795 (USP 795) and 797 (USP 797) and any updates published by USP. By December 1, 2019, all licensees engaged in compounding shall either be in compliance with USP 800, or shall submit a plan for coming into compliance to be reviewed and approved by the Board.

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DE USP 800 / USP 797 referene

FL USP 800 Rules: 465.0158 Nonresident sterile compounding permit. (3) (d) The applicant’s existing policies and procedures for sterile compounding, which must comply with pharmaceutical standards in chapter 797 of the United States Pharmacopoeia and any standards for sterile compounding required by board rule or current good manufacturing practices for an outsourcing facility. 64B16-27.700 Definition of Compounding. (3) Office Use compounding (3)(c) The quantity of compounded drug for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices. Rule 64B16-27.797 The Standards of Practice for Compounding Sterile Products. (2) Minimum Standards: The minimum practice and quality standards of the USP are adopted as the minimum standards to be followed when sterile products are compounded. However, nothing in this rule shall be construed to prevent the compounding of sterile products in accordance with standards that exceed the USP.

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FL USP 800 / USP 797 referene

GA USP 800 Rules: GA Law § 26-4-86. Compounding and distribution of drug products (a) The board shall establish rules and regulations governing the compounding and distribution of drug products by pharmacists, practitioners, and pharmacies licensed or registered by this state. Such rules and regulations shall include provisions ensuring compliance with USP-NF standards. GA Board of Pharmacy Rules Chapter 480-11 PHARMACEUTICAL COMPOUNDING Rule 480-11-.01 Definitions (30) "Sterile Preparations" are those as defined by USP 797. Rule 480-11-.02 Compounded Drug Preparations (5) Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding. (8) Pharmacists engaged in the compounding of pharmaceuticals shall operate in conformance with Georgia laws and regulations. Non-sterile compounded preparations shall be subject to USP 795. All sterile compounded preparations shall be subject to USP 797.

Notes: According to Board of Pharmacy staff, as changes or additions to the USP-NF standards become official per USP, those will be the standards that prescription drug compounders will be required to comply with per GA Law and Pharmacy Board Rules. This would include 800 and revisions to 795 and 797. From BOP announcement: "The board will continue to enforce existing chapters 795 and 797. Revised versions of those chapters, as well as the new chapter 825, will be enforced when they go into effect. The Georgia Drugs & Narcotics Agency (GDNA) will continue to use the inspection forms and tolls for existing chapters 795 and 797 and will not be inspecting for compliance with chapter 800 until USP releases revised versions of chapters 795 and 797. "Again, USP did not set a new effective date in its announcement. Pharmacies working toward chapter <800> compliance are strongly encouraged to take the time afforded by this delay to finalize those preparations.

GA USP 800 / USP 797 referene

HI USP 800 Rules: HAR Chapter 95: Pharmacists and Pharmacies Subchapter 13. §16-95-110 Grounds for revocation, suspension, refusal to renew or restore, denial, or conditioning of license or permit. (17) Failure to comply with the pharmaceutical compounding requirements found in chapters 795 (nonsterile preparations) and 797 (sterile preparations) of the United States Pharmacopeia National Formulary, as amended.

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HI USP 800 / USP 797 referene

ID USP 800 Rules: IDAPA 27.01.01 Subchapter H - Rules Governing Drug Compounding (Rules 700 through 799 - Rules Governing Drug Compounding) 700. COMPOUNDING DRUG PREPARATIONS. 05. Drug Compounding Controls. (7-1-18) a. Policies and Procedures. In consideration of the applicable provisions of USP Chapter 795 concerning pharmacy compounding of non-sterile preparations, USP Chapter 797 concerning sterile preparations, Chapter 1075 of the USP-NF concerning good compounding practices, and Chapter 1160 of the USP-NF concerning pharmaceutical calculations, policies and procedures for the compounding or sterile prepackaging of drug products must ensure the safety, identity, strength, quality, and purity of the finished product

Notes: Group of national pharmacy associations (APhA, NCPA, NACDS) asked the Board of Pharmacy not to act until 2021. BOP indicated it has no plans to pursue addt’l rule changes related to USP 800 in the near future.

ID USP 800 / USP 797 referene

IL USP 800 Rules: TITLE 68: PROFESSIONS AND OCCUPATIONS CHAPTER VII: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION SUBCHAPTER b: PROFESSIONS AND OCCUPATIONS PART 1330 PHARMACY PRACTICE ACT SECTION 1330.640 PHARMACEUTICAL COMPOUNDING STANDARDS Section 1330.640 Pharmaceutical Compounding Standards All pharmaceutical compounding standards, both sterile and nonsterile, shall be governed by the USP-NF (USP 41-NF 36), as set forth in the United States Pharmacopoeia (USP), 41st Revision and the National Formulary, 36th Edition, Compounding Compendium, with the exception of USP Chapter <800> as it pertains to the handling of hazardous drugs in health care settings. Beginning May 1, 2019, all pharmaceutical compounding standards, both sterile and nonsterile, shall be governed by the USP-NF (USP 42-NF 37), as set forth in the 2019 edition of the USP Compounding Compendium, with the exception of USP Chapter <800> as it pertains to the handling of hazardous drugs in health care settings.

Notes: Board of Pharmacy was asked for 5-year stay.

IL USP 800 / USP 797 referene

IN USP 800 Rules: Title 856. Article I: Pharmacy and Pharmacists 856 IAC 1-30-9 Personnel Sec. 9(c)(2) be responsible for adherence to all current USP Standards related to sterile compounding, personnel cleansing and gowning; or (3) reject or cause to be rejected any such shipment or drugs as prepared in violation of applicable USP Standards. 856 IAC 1-30-18 Quality assurance Authority: Sect. 18 (a) The designated qualifying pharmacist shall conduct a documented, ongoing quality assurance program that monitors personnel performance, equipment, and facilities. Samples of finished products shall be examined, or other continuous monitoring methods shall be used to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications in accordance with good compounding practices and the current USP/NF Chapter on sterile preparation.

Notes: Board of Pharmacy is in the process of reviewing 795, 797, and 800 based on recent USP revisions.

IN USP 800 / USP 797 referene

IA USP 800 Rules: Rule 657-20.3 - Nonsterile compounding Iowa-licensed pharmacies that compound nonsterile preparations for ultimate users in the state of Iowa shall follow the current revision of USP Chapter 795 standards. Additional USP chapters incorporated by reference into USP Chapter 795 shall also be followed. Rule 657-20.4 - Sterile compounding Iowa-licensed pharmacies that compound sterile preparations for ultimate users in the state of Iowa shall follow the current revision of USP Chapter 797 standards. Additional USP chapters incorporated by reference into USP Chapter 797 shall also be followed. Rule 657 IAC 8.5(11) Hazardous Drugs The pharmacy shall ensure pharmacy personnel and patients are adequately protected from unnecessary exposure to hazardous drugs. As of December 1, 2019, the pharmacy shall be in compliance with United States Pharmacopeia (USP) General Chapter 800 for handling hazardous drugs. A pharmacy engaged in compounding of hazardous drugs may request delayed compliance for specific requirements in USP General Chapter 800 pertaining to compounding, in accordance with rule 657—20.5(126,155A).

Notes: The Iowa Board of Pharmacy requires full compliance with United States Pharmacopoeia (USP) General Chapters <795>, <797>, and <800> as of December 1, 2019. Compliance with USP <800> is required for both compounding and non-compounding pharmacies (657 IAC 8.5(11)). This activity will assist pharmacists and pharmacy technicians in navigating these requirements. https://pharmacy.iowa.gov/press-release/2019-08-30/board-has-released-guide-navigating-usp-and-iowa Board scheduled a special teleconference for October 3 to discuss enforcement of USP 795, 797, & 800.

IA USP 800 / USP 797 referene

KS USP 800 Rules: 68-13-2 Definitions (ff) “Official compendium” has the meaning specified in K.S.A. 65-656, and amendments thereto. (pp) “Simple nonsterile compounding” means either of the following: (1) Making a nonsterile preparation that has a compounding monograph listed in the official compendium or that appears in a peer‐reviewed journal containing specifics on component quantities, compounding procedure, equipment, and stability data for the formulation and appropriate beyond-use dates; 68-13-3 Nonsterile Preparations. (d) A pharmacist shall not compound a nonsterile preparation by any of the following methods: (2) receiving, storing, or using any drug component that is not guaranteed or otherwise determined to meet the requirements of an official compendium; (3) compounding finished drugs from bulk active ingredients that do not meet the requirements of a monograph listed in the official compendium; 68-13-4 Sterile Preparations. (9)(x)(3) Each high-risk sterile preparation made with nonsterile components shall be sterilized before being administered to a patient and shall have a certificate of analysis indicating that all nonsterile components meet the standards of the “United States pharmacopeia” and the FDA for identity, purity, and endotoxin levels as verified by a pharmacist.

Notes: USP 795 and 797 were consulted, but the language was the language agreed upon by the Board, stakeholders, other important people like the Attorney General’s office and the Department of Administration, according to the Board of Pharmacy director of compliance. The Board of Pharmacy is planning to review the June 2019 USP revisions to 795 and 797; however, the board does not anticipate having language rewritten to reflect those changes until after the middle of next year, at the earliest. (New or revised regulations must go through a somewhat lengthy process plus a public hearing after a 60-day notice). The board is also looking at how this can best to adopt USP 800; however, compliance is strongly encouraged since the federal regulator is OSHA.

KS USP 800 / USP 797 referene

KY USP 800 Rules: 201 KAR 2:076. Compounding Section 2. (1) Effective January 1, 2018, all non-sterile compounded preparations shall be compounded pursuant to United States Pharmacopeia (USP) 795, unless specified portions submitted by a pharmacist have been waived by the Board. (2) Effective January 1, 2018, all sterile compounded preparations shall be compounded pursuant to USP 797, unless specified portions submitted by a pharmacist have been waived by the Board.

Notes: Board of Pharmacy is delaying implementation for one year. Board staff said that if a compounding pharmacy is found to be noncompliant during an inspection after December 1, the pharmacy will only be issued a citation for noncompliance and no other action will be taken. Board thinks it's still going to take awhile for compounding pharmacies to fully comply, so they're proposing this to give more time. https://pharmacy.ky.gov/Documents/Comments%20on%20HDC%20Committee%20recommendations.pdf

KY USP 800 / USP 797 referene

LA USP 800 Rules: §2535. General Standards 2. All compounding shall be accomplished utilizing accepted pharmacy techniques, practices, and equipment, as well as the Federal Food, Drug and Cosmetic Act of 1938 as subsequently amended, most recently in November 2013 (FDCA), the 2016 edition of Title 21 of the Code of Federal Regulations (CFR), and all relevant chapters of the 2014 edition of the United States Pharmacopeia-National Formulary (USP 37 – NF 32). a. The compounding of sterile preparations pursuant to the receipt of a patient specific prescription shall comply with the provisions of Section 503-A of the FDCA and USP Chapter 797. b. The compounding of non-sterile preparations pursuant to the receipt of a patient specific prescription shall comply with the provisions of Section 503-A of the FDCA and USP Chapter 795. c. The compounding of preparations for veterinary use shall comply with the provisions of Section 530 of Title 21 of the CFR. d. The compounding of positron emission tomography (PET) drugs shall comply with the provisions of Section 212 of Title 21 of the CFR.

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LA USP 800 / USP 797 referene

ME USP 800 Rules: 7. Compounding 2. Operational Requirements USP Chapter 795 – A non-sterile compounding pharmacy shall comply in all respects with United States Pharmacopeia USP 36-NF 31, General Chapter <795>, Pharmaceutical Compounding – Nonsterile Preparations, 2013-14 edition, Vol. 1, p. 355. (“Chapter 795”). The board incorporates Chapter 795 into this chapter by reference. 10. Operational Requirements A sterile compounding pharmacy shall comply in all respects with United States Pharmacopeia USP 36-NF 31, General Chapter <797>, Pharmaceutical Compounding – Sterile Preparations, 2013-14 edition, Vol. 1, p. 361 (“Chapter 797”). The board incorporates Chapter 797 into this chapter by reference

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ME USP 800 / USP 797 referene

MD USP 800 Rules: 10.34.19.02. 02 Incorporation by Reference.. In this chapter, the following documents are incorporated by reference:. A. U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding― Sterile Preparations (USP 797 Standards) which has been incorporated by reference in 21 U.S.C. §351(b) (as amended)B. U.S. Pharmacopeia (USP) General Chapter 795 Pharmaceutical Compounding―Non-Sterile Preparations (USP 795 Standards) which has been incorporated by reference in 21 U.S.C. §3

Notes: From the August 21 Board of Pharmacy Practice Committee report: The Board of Pharmacy will be enforcing USP-797, as amended, when the amendments become effective. The board plans to begin inspecting for the new standards when they become effective; however, the board may take into consideration reasonable implementation timelines for certain gaps that are identified. The board is not currently enforcing USP-800 specifically; however, please be advised that provisions that overlap with USP-797 will be enforced. Board did not respond to question of when it would adopt USP 800.

MD USP 800 / USP 797 referene

MA USP 800 Rules: 247 CMR 6.00: REGISTRATION, MANAGEMENT AND OPERATION OF A PHARMACY OR PHARMACY DEPARTMENT 6.15: Duty to Report Certain Factors of Pharmacy Operations (1) Definitions (f) Sterile compounding means the preparation, mixing, assembling, packaging, and labeling of a drug or device that is required to be prepared in accordance with United States Pharmacopeia General Chapter 797 and dispensed pursuant to a valid prescription as defined by 247 CMR 2.00 247 CMR 9.00: CODE OF PROFESSIONAL CONDUCT; PROFESSIONAL STANDARDS FOR REGISTERED PHARMACISTS, PHARMACIES AND PHARMACY DEPARTMENTS 9.01: Code of Professional Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments (3) A pharmacist shall observe the standards of the current United States Pharmacopoeia. Chapter 159: Section 39D “Complex non-sterile drug preparation”, a compounded drug preparation which requires special training, a special environment or special facilities or equipment or the use of compounding techniques and procedures that may present an elevated risk to the compounder or the patient, as defined by the board through regulation; provided, that the regulations promulgated by the board, which are applicable to this definition, shall be consistent with the category of complex non-sterile compounding described in chapter 795 of the USP.

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MA USP 800 / USP 797 referene

MI USP 800 Rules: 333.17709 Definitions; S to W. (2) "Sterile pharmaceutical" means a dosage form of a drug that is essentially free from living microbes and chemical or physical contamination to the point at which it poses no present risk to the patient, in accordance with USP standards. 333.17748a Compounding services for sterile pharmaceuticals; (2) By September 30, 2016, a pharmacy that is licensed on September 30, 2014 and that provides compounding services for sterile pharmaceuticals must be accredited by a national accrediting organization approved by the board, be verified by the board as being in the accreditation process, or be in compliance with USP standards in a manner determined by the board. 333.17748b Compounding nonsterile or sterile pharmaceuticals for prescriber or health facility or agency to administer to patients without prescription; (1)(e) The conditions of operation including practices consistent with USP standards and requirements for sterility testing.

Notes: Board of Pharmacy indicates it will be adopting 795, 797, and 800 by reference in 2019. Hearing: October 4.

MI USP 800 / USP 797 referene

MN USP 800 Rules: 6800.3300 COMPOUNDING STANDARDS. Subpart 1. Standards for nonsterile compounding. All licensed Minnesota pharmacies that compound nonsterile drug preparations must follow United States Pharmacopeia, chapter 795, standards. Subp. 2. Standards for sterile compounding. Any licensed Minnesota pharmacy compounding a sterile product must follow the United States Pharmacopeia, chapter 797, standards. Statutes 151.253 COMPOUNDING. Subd. 2.Compounded drug. A drug product may be compounded under this section if a pharmacist or practitioner: (A) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;

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MN USP 800 / USP 797 referene

MS USP 800 Rules: TITLE 30: PROFESSIONS AND OCCUPATIONS PART 3001: MISSISSIPPI PHARMACY PRACTICE REGULATIONS ARTICLE XXXI COMPOUNDING GUIDELINES Every pharmacy permitted by the Mississippi Board of Pharmacy engaged in the compounding of pharmaceuticals shall comply with USP 797 and 795 standards.

Notes: The Mississippi Board of Pharmacy encourages all permitted pharmacies to continue to work towards adhering to the 2019 USP 795, 797, 800, and 825 publications. However, the Board wants to give some clarification regarding what will be enforced effective 12/1/2019: The new definitions for Beyond Use Date for Immediate use and Category I will be allowed. Pharmacies should continue to adhere to the pre 12/1/19 USP 795 and 797 chapters as a minimum. Note: The MS Board of Pharmacy in partnership with other Boards of Pharmacy is continuing to assess the 2019 versions of USP 795 and 797 and will issue further guidance at a later time. Pharmacies that compound or manipulate hazardous drugs should at a minimum complete assessment of risks and develop a plan to protect all individuals from these risks. All compounding, sterile and non-sterile, of antineoplastics must adhere to USP 800. The MS Board of Pharmacy will issue further guidance at a later time concerning other USP 800 compliance. USP 825 will be adopted as written and an update to the regulations is moving through the approval process.

MS USP 800 / USP 797 referene

MO USP 800 Rules: 20 CSR 2220-2.200 Sterile Compounding (EE) USP: The United States Pharmacopeia and the National Formulary (USPNF) as adopted and published by the United States Pharmacopeial Convention, effective May 2013. Copies of the USP-NF are published by, and available from, USP, 12601 Twinbrook Parkway, Rockville, MD 20852- 1790 or online at http://www.usp.org/. The USP-NF is incorporated herein by reference. This rule does not include any later amendments or additions to the USP-NF.

Notes: Nonsterile compounding not specifically addressed in the rules. USP 797 hasn't been fully adopted; rules are similar to USP 797. Board of Pharmacy executive director said board's sterile compounding subcommittee is reviewing the USP chapters and will make a recommendation to board regarding possible adoption. Anticipates finalizing review by end of the year. No set timeframe for adoptions.

MO USP 800 / USP 797 referene

USP 800 Rules:

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USP 800 / USP 797 referene

NE USP 800 Rules: 38-2867.01. Authority to compound; standards; labeling; prohibited acts. (1) Any person authorized to compound shall compound in compliance with the standards of chapters 795 and 797 of The United States Pharmacopeia and The National Formulary, as such chapters existed on January 1, 2015, and shall compound (a) as the result of a practitioner's medical order or initiative occurring in the course of practice based upon the relationship between the practitioner, patient, and pharmacist, (b) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing, or (c) for office use only and not for resale.

Notes: According to Board of Pharmacy office administrator, revisions to USP 795 and 797 will not be revisited or enforced until changed by statute. Until then, the 2015 USP-NF is the standard being used (see "Specific Law/Rule Text" column. USP 800 also will not be enforced until it's put into statute by the legislature. No timeframe was given when that may be done. Compounding pharmacies are expected to comply with 800, though.

NE USP 800 / USP 797 referene

NV USP 800 Rules: NAC 639.6677 “Sterile compounded drug product” defined. (NRS 639.070) “Sterile compounded drug product” means a drug product the preparation and dispensing of which require compounding and which is required to be sterile by either the provisions of chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670, or the provisions of NAC 639.661 to 639.690, inclusive. NAC 639.670 Adoption of certain publications by reference; revision of publication after adoption. (NRS 639.070, 639.2807) 1. The Board hereby adopts by reference the following: (c) United States Pharmacopeia - National Formulary, 2008 edition, published by the United States Pharmacopeial Convention. A copy of this publication may be obtained from the United States Pharmacopeial Convention, Customer Service Department, 12601 Twinbrook Parkway, Rockville, Maryland 20852, or at the Internet address http://www.usp.org/products/, for the price of $755.

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NV USP 800 / USP 797 referene

NH USP 800 Rules: PART Ph 404 STANDARDS FOR COMPOUNDING AND DISPENSING STERILE AND NON-STERILE PHARMACEUTICALS Ph 404.01 Purpose and Scope. (b) The board shall require all compounders engaging in compounding in all situations to adhere to and comply with the current edition of the United States Pharmacopeia including but not limited to Chapters 795 (USP 795) and 797 (USP 797), following those guidelines that apply to their practice setting. These chapters shall be reviewed in full and followed by compounders prior to non-sterile or sterile pharmaceutical compounding. These regulations shall apply to non-sterile and sterile compounding of medications.

Notes: Section 404.01 could be interpreted to include 800. Language says "including but not limited to" 795 and 797.

NH USP 800 / USP 797 referene

NJ USP 800 Rules: 13:39-11A.10 RESPONSIBILITIES OF THE COMPOUNDING PHARMACIST; REPORTING REQUIREMENT 5) Compounded preparations are of acceptable strength, quality, and purity, with appropriate packaging and labeling, and are prepared in accordance with good compounding practices, official standards, and relevant scientific data and information as set forth in USP 795, which is incorporated herein by reference, as amended and supplemented 13:39-11.16 TRAINING AND EVALUATION REQUIREMENTS c) The pharmacist-in-charge shall be responsible for testing of the aseptic technique of all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations consistent with the methods set forth in USP 797 concerning “Aseptic Manipulation Competency Evaluation,” incorporated herein by reference, SUBCHAPTER 11B. COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS SUBSTANCES: STERILE AND NON-STERILE PREPARATIONS 13:39-11B.1 PURPOSE AND SCOPE b) Effective on the effective date of USP 800 (currently, December 1,2019), the compounding of antineoplastic agents and other hazardous substances shall be consistent with the standards established in USP 800, which is incorporated herein by reference, as amended and supplemented

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NJ USP 800 / USP 797 referene

NM USP 800 Rules: 16.19.30.9 OPERATIONAL STANDARDS F. Compounding process. The safety, quality and performance of compounded prescriptions depend on correct ingredients and calculations, accurate and precise measurements, appropriate formulation conditions and procedures, and prudent pharmaceutical judgment. Each pharmacy shall develop and follow written SOP’s based on established compounding procedures as outlined in chapter 795 of the USP/NF concerning pharmacy compounding of non-sterile preparations designed to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process. 16.19.36.11 DOCUMENTATION REQUIRED A. Written policies, procedures and SOPs consistent with USP/NF <797> (General Chapter <797> Pharmaceutical Compounding Sterile Preparations) standards as well as those required below, must be established, implemented, followed by facility personnel, and available for inspection and review by authorized agents of the board of pharmacy.

Notes: Although there is no regulation published adopting USP 800, the Board of Pharmacy's home page has the following posted: USP <800> USP <800> becomes effective December 1, 2019, and applies to both sterile and non-sterile hazardous drug compounding. Assess your readiness. A USP <800> Gap Analysis Tool is available at: http://www.800gaptool.com/

NM USP 800 / USP 797 referene

NY USP 800 Rules:

Notes: USP 795, 797, and 800 not specifically incorporated in state rules. Board of Pharmacy staffer said compounders are expected to follow federal laws and rules. As the board does not have an executive director, staffer indicated is not clear if and when the board would address USP 795 and 797. USP 800 was on the agenda for the board's Sept. 17 meeting.

NY USP 800 / USP 797 referene

NC USP 800 Rules: 21 NCAC 46 .2801 COMPOUNDING (d) The preparation, labeling, and dispensing of non-sterile compounded drug preparations shall comply with the standards established by United States Pharmacopeia chapter <795>, including all United States Pharmacopeia chapters and standards incorporated into chapter <795> by reference and including all subsequent amendments and editions of the same, governing both the non-sterile compounded drug preparations and the physical and environmental conditions under which non-sterile compounded drug preparations are prepared, labeled, and dispensed. (e) The preparation, labeling, and dispensing of sterile compounded preparations shall comply with standards established by United States Pharmacopeia chapter <797>, including all United States Pharmacopeia chapters and standards incorporated into chapter <797> by reference and including all subsequent amendments and editions of the same, governing both the sterile compounded products and the physical and environmental conditions under which sterile compounded products are prepared, labeled, and dispensed.

Notes: Board pf Pharmacy staff will not begin inspecting for compliance with USP chapter <800> standards in compounding activities on December 1, 2019. Existing chapters <795> and <797> do not incorporate chapter <800>. Revised chapters <795> and <797> do. Accordingly, Board staff will begin inspecting for compliance with chapter <800> standards at such time as the revised chapters go into effect. Again, USP did not set a new effective date in its announcement today. Pharmacies that have already implemented changes to comply with chapter <800> are commended for doing so. And pharmacies working toward chapter <800> compliance are strongly encouraged to take the time afforded by this delay to finalize those preparations. For a review of prior Board statements concerning USP <800>, see http://www.ncbop.org/PDF/BoardPositionStatementforUSP800UPDATEDMarch2019.pdf andhttp://www.ncbop.org/PDF/NCBOP_USP_800_Statement.pdf

NC USP 800 / USP 797 referene

ND USP 800 Rules: 61-02-01-03. Pharmaceutical compounding standards. 3. Nonsterile compounding. Compounders are to use the following steps to minimize error and maximize the prescriber's intent, specifics can be found in pharmaceutical compounding - nonsterile compounding (USP 795) 4. Compounding process for compounded sterile preparations. Compounders are to follow the USP chapter 797 standards and use the following steps to minimize error and maximize the prescriber's intent: d. Sterile compounding areas and critical areas must be structurally isolated from other areas designated to avoid unnecessary traffic and airflow disturbances according to USP chapter 797, separate from nonsterile compounding areas, and restricted to qualified compounding personnel. e. Policies and procedures must be established in accordance with USP chapter 797 for personnel cleaning and garbing for protection and avoidance of containment. f. Clean and sanitize the compounding area and needed equipment according to USP chapter 797. 5. Facilities for sterile compounding should conform with USP chapter 797. 6. Equipment specific for sterile compounding should conform with USP chapter 797. 10. Compounding of hazardous drugs. a. Hazardous drugs shall be prepared under conditions that protect the health care worker and other personnel in the preparation and storage areas according to USP chapter 800. Appropriate personnel protective equipment shall be worn when compounding hazardous drugs according to USP chapter 800. b. Hazardous drugs shall be stored and prepared separately from other nonhazardous drugs in a manner to prevent contamination and personnel exposure according to USP chapter 800.). c. Hazardous drugs shall be handled by the pharmacy according to USP chapter 800.

Notes: Board of Pharmacy developed a USP 800 Toolkit for pharmacies. Must set up account to access. Use BOP link in "Website Link" column. Adopted 800 by reference (see new text at section 61-02-01-03(10); effective: October 1.

ND USP 800 / USP 797 referene

OH USP 800 Rules: 4729-16-03 Drugs compounded in a pharmacy. A) For all non-sterile compounded drug products, the pharmacy shall comply with the United States pharmacopeia chapter <795>, USP 38 - NF 33, or any official supplement thereto B) For all sterile compounded drug products, the pharmacy shall comply with the United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto.

Notes:

OH USP 800 / USP 797 referene

OK USP 800 Rules: 535:15-10-52. Pharmacist responsibilities (b) Every pharmacist engaging in drug compounding must be familiar with all details of USP Compounding Standards. (g) All pharmacists who engage in sterile compounding are responsible for complying with all aspects of USP Compounding Standards and these rules.

Notes: USP 800 not going into effect until July 1, 2021. According to the Board of Pharmacy, the 2019 revised rules were not published in the Oklahoma Administrative Code as required by the Oklahoma Rules on Rulemaking, which makes all of them null and void. The board plans to take new rulemaking action before the next legislative session. The legislature reconvenes on February 4, 2020.

OK USP 800 / USP 797 referene

OR USP 800 Rules: Chapter 855 Division 45 DRUG COMPOUNDING (3) Whilst the Board does not insist on rigid application of, or adherence to, all the guidelines of the current edition of the United States Pharmacopeia Chapters 795 (USP 795) and 797 (USP 797), it expects pharmacists engaging in compounding to adhere to those guidelines that apply to their practice setting and in all situations to comply with the spirit of USP 795 and USP 797.

Notes:

OR USP 800 / USP 797 referene

PA USP 800 Rules: TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS CHAPTER 27. STATE BOARD OF PHARMACY GENERAL PROVISIONS § 27.601. Compounding of preparations. The compounding of sterile and nonsterile preparations shall be done in accordance with section 503a of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 353a), Federal regulations promulgated thereunder, and the current version of the USP chapters governing compounding.

Notes: Board of Pharmacy published finalized, adopted, new compounding regulations on June 22, 2019. § 27.601. Compounding of preparations in the "Law/Rule Text" column is the new provision.

PA USP 800 / USP 797 referene

RI USP 800 Rules: 1.7 Compounding of Pharmaceuticals A. General Requirements: Non-sterile and Sterile Compounding 9. Compounding personnel shall be responsible for ensuring that compounded preparations are accurately identified, measured, diluted, and mixed; are correctly packaged, sealed, labeled, stored, dispensed, and distributed. Ingredients shall be of the correct identity, quality, and purity. Appropriate cleanliness shall be maintained. Proper labeling and supplementary instructions for the clinical administration of CSPs shall be provided by a pharmacist. Beyond-use dates shall be determined based upon current USP standards and documented testing or literature and professional judgment. 10. Bulk and active ingredients used in the preparation of compounded sterile products (CSPs), and non-sterile compounded products shall be USP or National Formulary (NF) certified or shall be accompanied by a certificate of analysis for inspection by the Department upon request. 216-RICR-40-15-1 B. General Requirements-- All Risk Levels: Sterile Compounding. The pharmacist-in-charge shall ensure the following activities are accomplished for all sterile compounding as outlined in current USP standards

Notes: Law/Rule Text" column not large enough to include all the compounding requirements the reference USP. Click on link in "website link" column to access the complete rule.

RI USP 800 / USP 797 referene

SC USP 800 Rules:

Notes: Board of Pharmacy is monitoring USP 795, 797, and 800. No plan to adopt at this stage.

SC USP 800 / USP 797 referene

SD USP 800 Rules: 20:51:31:25. Sterilization methods. The pharmacist shall select the sterilization method that complies with the standards identified in United States Pharmacopoeia, Chapter 797.

Notes: Board proposed rules to adopt updated chapters of USP/NF. Hearing: October 15.

SD USP 800 / USP 797 referene

TN USP 800 Rules: 1140-07-.02 STANDARDS. (1) All sterile products shall be prepared in compliance with applicable USP standards for pharmaceutical compounding

Notes: USP implementation delay is for revisions to 795 and 797. It’s not clear if the Board of Pharmacy's website post would cover 800 when it goes into effect. Posted on website: The Tennessee Board of Pharmacy is currently only empowered by statute and rule to enforce applicable USP standards for sterile compounding. While the appeals process continues for these new standards with USP, the current standards for sterile compounding will continue to be enforced. We encourage all compounders of sterile and non-sterile products to continue to protect their patients and employees safety in compounding medications and promotion of safe handling of hazardous drugs.

TN USP 800 / USP 797 referene

TX USP 800 Rules: 22 TAC, PART 15 §291.131 Pharmacies Compounding Non-Sterile Preparations (2) Library. In addition to the library requirements of the pharmacy's specific license classification, a pharmacy shall maintain a current copy, in hard-copy or electronic format, of Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations. §291.133 Pharmacies Compounding Sterile Preparations (d) Operation Standards. (d)(2) Microbial Contamination Risk Levels. Risk Levels for sterile compounded preparations shall be as outlined in Chapter 797, Pharmacy Compounding--Sterile Preparations of the USP/NF and as listed in this paragraph (d)(5) Library. In addition to the library requirements of the pharmacy's specific license classification, a pharmacy shall maintain current or updated copies in hard-copy or electronic format of each of the following: (B) a specialty reference text appropriate for the scope of pharmacy services provided by the pharmacy, e.g., if the pharmacy prepares hazardous drugs, a reference text on the preparation of hazardous drugs; (C) the United States Pharmacopeia/National Formulary containing USP Chapter 71, Sterility Tests, USP Chapter 85, Bacterial Endotoxins Test, Pharmaceutical Compounding--Nonsterile Preparations, USP Chapter 795, USP Chapter 797, Pharmaceutical Compounding--Sterile Preparations, and USP Chapter 1163, Quality Assurance in Pharmaceutical Compounding; and (D) any additional USP/NF chapters applicable to the practice of the pharmacy (e.g., USP Chapter 800, Hazardous Drugs--Handling in Healthcare Settings, USP Chapter 823, Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses). (d)(13) Compounding process. (B) USP/NF. Any compounded formulation with an official monograph in the USP/NF shall be compounded, labeled, and packaged in conformity with the USP/NF monograph for the drug. (15) Quality control. (A) Quality control procedures. The pharmacy shall follow established quality control procedures to monitor the compounding environment and quality of compounded drug preparations for conformity with the quality indicators established for the preparation. When developing these procedures, pharmacy personnel shall consider the provisions on-sterile Preparations, USP Chapter 795, USP Chapter 797, Pharmaceutical Compounding--Sterile Preparations, USP Chapter 800, Hazardous Drugs--Handling in Healthcare Settings.

Notes: Board of Pharmacy uses a hybrid approach in which it implements its own rules and in some areas references USP 795 and 797 for pharmacists to consider (this not the same as adopting or adopting by reference), according to board staff. Pharmacists are required to keep copies of 795, 797, and 800 in their libraries. Board staff also said the board decided not to adopt 800.

TX USP 800 / USP 797 referene

UT USP 800 Rules: R156-17b-614a. Operating Standards - General Operating Standards, Class A and B Pharmacy. (3)(a) Facilities shall follow USP-NF Chapter 795, compounding of non-sterile preparations, and USP-NF Chapter 797 if compounding sterile preparations.

Notes:

UT USP 800 / USP 797 referene

VT USP 800 Rules: Part 10 Pharmacy Practice 10.23 Drugs Compounded in a Pharmacy (b) Every pharmacist who engages in non-sterile drug compounding shall be proficient, in the art of compounding and shall maintain that proficiency through participation in seminars, studying appropriate literature and/or becoming certified by a compounding certification program. Also, every pharmacist who engages in drug compounding must practice in accordance with NABP’s Good Compounding Practices. Part 13 Sterile Pharmaceuticals 13.22 USP 797 Compliance for Compounded Sterile Products (a) All pharmacies, either in state or out of state, dispensing or distributing compounded sterile products as defined by USP 797 to Vermont patients, institutions or providers shall meet all requirements of USP 797.

Notes:

VT USP 800 / USP 797 referene

VA USP 800 Rules: 18VAC110-20-321. Compounding A. The compounding of both sterile and nonsterile drug products by a pharmacy that does not share the same physical space with an outsourcing facility shall be performed in accordance with USP-NF compounding standards and § 54.1-3410.2 of the Code of Virginia.

Notes: §54.1-3410.2 is the adopted by reference section. Board of Pharmacy said it “cannot legally require compliance with USP 800 related to compounding until the appeals of 795 and 797 are resolved and the revised chapters become effective.”

VA USP 800 / USP 797 referene

WA USP 800 Rules: RCW 18.64.270 Responsibility for drug purity—Compounding —Adulteration—Penalty. (2) Any medicinal products that are compounded for patient administration or distribution to a licensed practitioner for patient use or administration shall, at a minimum, meet the standards of the official United States pharmacopeia as it applies to nonsterile products and sterile administered products.

Notes: From an email sent by the Pharmacy Quality Assurance Commission (PQCA) to pharmacists and others. In August, the commission adopted a position to allow early adoption of the revised chapters and early adoption of 800. The commission is aware of the uncertainty this delay has for its licensees and other entities engaged in the construction of complaint compounding facilities. At this point the commission is looking into options to help alleviate this uncertainty, and plans to discuss next steps regarding the announcement from USP at their October 25, 2019 meeting. Additionally, in its Rule Rewriting Project, PQAC has drafted rules that would adopt USP Chapters 795, 797, 800, and 825 by reference. PQAC recent sent out its fourth version to stakeholders for review and comment.

WA USP 800 / USP 797 referene

WV USP 800 Rules: 15 CSR 1 16.3. The compounding environment for this practice shall be separate rooms set apart from all other activities. The environment shall facilitate controlled aseptic conditions and meet all standards of the United States Pharmacopeial Convention (USP)

Notes: Board of Pharmacy discussed USP 795, 797, and 800 at its Sept. 29-30 meeting. The BOP still plans to adopt the revised 795 and 797 chapters and 800 before December 1. Board staffer said carve outs will be made for 795. There will be further discussion at the board's November meeting.

WV USP 800 / USP 797 referene

WI USP 800 Rules: Chapter Phar 15-Compounding Pharmaceuticals "Phar 15.01 Intent The intent of this chapter is to create a state regulatory standard that aligns with compounding standards found in the United States Pharmaceopeia (USP) general chapters lower than the number 1000".

Notes: Wisconsin Board of Pharmacy issued a notice that it intends to propose a rule to align its compounding rules with the recently updated USP 795 and 797 standards. Board will review the changes to 795 and 797 and then draft a proposed rule. http://docs.legis.wisconsin.gov/code/register/2019/765A2/register/ss/ss_096_19/ss_096_19.pdf

WI USP 800 / USP 797 referene

WY USP 800 Rules: Chapter 17 Section 2 (b) Each standard incorporated by reference in these rules is further identified as follows: (i) The United States Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding – Sterile Preparations incorporated by reference in this Chapter of these rules is the USP as existing on July 27, 2018 including amendments adopted by USP as of that date. Copies of this standard can be obtained from the Board at 1712 Carey Avenue, Suite 200, Cheyenne, Wyoming, 82002.

Notes:

WY USP 800 / USP 797 referene

USP 800: State-by-state

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