42 CFR 482.25 - Condition of participation: Pharmaceutical services.

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§ 482.25 Condition of participation: Pharmaceutical services.
The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital's organized pharmaceutical service.
(a) Standard: Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted professional principles.
(1) A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.
(2) The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.
(3) Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.
(b) Standard: Delivery of services. In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.
(1) All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws.
(2)
(i) All drugs and biologicals must be kept in a secure area, and locked when appropriate.
(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area.
(iii) Only authorized personnel may have access to locked areas.
(3) Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.
(4) When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law.
(5) Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff.
(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital's quality assessment and performance improvement program.
(7) Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.
(8) Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff.
(9) A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs.
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694, Nov. 27, 2006; 77 FR 29075, May 16, 2012]

Title 42 published on 2013-10-01

The following are only the Rules published in the Federal Register after the published date of Title 42.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-05-12; vol. 79 # 91 - Monday, May 12, 2014
    1. 79 FR 27106 - Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Final rule.
      These regulations are effective on July 11, 2014, with the exception of amendments to 42 CFR Part 483, which are effective May 12, 2014.
      42 CFR Parts 413, 416, 440, 442, 482, 483, 485, 486, 488, 491, and 493

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United States Code

Title 42 published on 2013-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR 482 after this date.

  • 2014-05-12; vol. 79 # 91 - Monday, May 12, 2014
    1. 79 FR 27106 - Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Final rule.
      These regulations are effective on July 11, 2014, with the exception of amendments to 42 CFR Part 483, which are effective May 12, 2014.
      42 CFR Parts 413, 416, 440, 442, 482, 483, 485, 486, 488, 491, and 493