{"id":1132,"date":"2023-11-16T15:03:25","date_gmt":"2023-11-16T23:03:25","guid":{"rendered":"https:\/\/www.cdcr.ca.gov\/hcdom\/?post_type=dom&#038;p=1132"},"modified":"2024-12-30T11:18:12","modified_gmt":"2024-12-30T19:18:12","slug":"3-5-18-repackaging-and-compounding-medications","status":"publish","type":"dom","link":"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-18-repackaging-and-compounding-medications\/","title":{"rendered":"3.5.18 Repackaging and Compounding Medications"},"content":{"rendered":"\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p><strong>Procedure Overview<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>Repackaging and compounding of medications shall comply with applicable federal and state regulations. \u00a0All non-injectable compounded medications shall be considered nonformulary. \u00a0If compounded medications are needed, California Correctional Health Care Services (CCHCS) shall procure from a licensed compounding pharmacy whenever possible. \u00a0The Pharmacist-in-Charge is responsible for ensuring compliance with this policy and procedure.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p><strong>Purpose<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>To define methods for repackaging, labeling, and compounding medications.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p><strong>Procedure<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p><strong>Repackaging<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Repackaging is governed by the Food, Drug, and Cosmetic Act and the United States Pharmacopeia (USP).<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Central Pharmacy Services shall register and maintain licensure as a repackager under the Food and Drug Administration (FDA). \u00a0Central Pharmacy Services shall maintain a complete set of standard operating procedures consistent with current Good Manufacturing Practices.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Correctional pharmacies within the institution may conduct limited repackaging to service the licensed correctional clinics or licensed inpatient units within the institution without registering as a licensed repackager.\u00a0 Refer to Section (c)(1)(C) below.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Repackaging by Central Pharmacy Services<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>Beyond-use dating from the Central Pharmacy Services repackager shall be (whichever is shorter):<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Up to one year from the date packaged as determined by the repackaging materials utilized,<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The manufacturer\u2019s expiration date, or<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The beyond-use date specified by the manufacturer once the product is opened.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Repackaging by a Correctional Pharmacy<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Pharmacies shall comply with FDA guidance, which states that pharmacies may repackage drugs under the following conditions:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The facility is licensed by the state as a pharmacy.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The repackaging is done by or under the supervision of a licensed pharmacist.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The product is repackaged in a way that does not conflict with drug product labeling.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The repackaged drug product conforms to specific beyond-use dating.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The repackaged product is not sold or transferred by a pharmacy other than the one that repackaged the product.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Prior to starting the repackaging process, a pharmacist must check a sample label, verify the drug product, the beyond-use date, and review the batch control entry in the repackaging log.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Pharmacies shall comply with beyond-use dating requirements as set by the USP, which permits repackaged products to bear the shorter of the following dates:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Six months from the date packaged,<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The manufacturer\u2019s expiration date, or<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The beyond-use date specified by the manufacturer once the product is opened.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Repackaging Logs<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The repackaging logs for each repackaged medication shall include the following information:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Generic medication name<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Trade medication name (if any)<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Strength<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Manufacturer<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Manufacturer&#8217;s lot number<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Manufacturer&#8217;s expiration date<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Control or batch number (facility assigned)<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Number of units repackaged (total doses repackaged and total packages created)<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Date repackaged<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Initials of the pharmacy staff repackaging<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Initials of the pharmacist completing final check<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The pharmacist shall check the repackaging logs for completeness and repackaged medications for expiration and beyond-use dates during monthly medication quality assurance rounds.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The repackaging logs must be retained for three years.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Labeling Repackaged Medications<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>Each label of the repackaged medication shall include:<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Generic medication name<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Most common trade medication name (if any)<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Strength<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Quantity in the package<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Manufacturer<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Control or batch number (facility assigned and unique for each batch of repackaged drug)<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Date repackaged<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Beyond-use date as outlined above in Section (c)(1)(C)2<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Initials of the person repackaging<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p><strong>Compounded Medications<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>CCHCS pharmacies are not currently equipped and licensed for compounding. \u00a0If compounded medications are needed, alternative methods of obtaining the product shall be sought.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>For sterile compounded medications:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Whenever possible, closed systems (e.g., ADD-Vantage, Mini-Bag Plus) and commercially available products shall be dispensed by pharmacy to allow licensed health care staff to prepare at bedside as close to the administration time as possible.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>If unavailable, the compounded medication may be ordered and prepared by a state-contracted sterile compounding vendor.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Refer to Health Care Department Operations Manual, Section <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-29-medication-administration\/\" data-type=\"link\" data-id=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-29-medication-administration\/\">3.5.29, Medication Administration<\/a>, for more details on administering intravenous therapy.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>For non-sterile compounded medications:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Whenever possible, providers shall prescribe\/order and pharmacies shall procure commercially available products that do not require combining ingredients or drugs.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>If unavailable and with strong clinical justification provided, the compounded medication may be ordered and prepared by a state-contracted compounding vendor.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p><strong>References<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>Business &amp; Professions Code, Chapter 9, Division 2, Article 3, Section 4052.7, Repackaged Previously Dispensed Drugs<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>California Code of Regulations, Division 17, Title 16, Article 2, Section 1715, Self-Assessment of a Pharmacy by the Pharmacist-in-Charge<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>California Code of Regulations, Division 17, Title 16, Article 4.5, Section 1735, Compounding in Licensed Pharmacies<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>California Code of Regulations, Division 17, Title 16, Article 4.5, Section 1735.2, Compounding Limitations and Requirements; Self-Assessment<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>California Code of Regulations, Division 17, Title 16, Article 4.5, Section 1735.3, Recordkeeping of Compounded Drug Preparations<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>California Code of Regulations, Division 17, Title 16, Article 4.5, Section 1735.4, Labeling of Compounded Drug Preparations<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>Health Care Department Operations Manual, Chapter 3, Article 5, Section <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-29-medication-administration\/\" data-type=\"link\" data-id=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-29-medication-administration\/\">3.5.29, Medication Administration<\/a><\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>Food, Drug, and Cosmetic Act Chapter V, Sections 503A.\u00a0 Pharmacy Compounding<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p><a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-issues-final-guidance-repackaging-and-revised-draft-guidance-mixing-diluting-and-repackaging#:~:text=Repackaged%20drug%20products%20are%20generally,compounding%2C%20do%20not%20address%20repackaging\" data-type=\"link\" data-id=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-issues-final-guidance-repackaging-and-revised-draft-guidance-mixing-diluting-and-repackaging#:~:text=Repackaged%20drug%20products%20are%20generally,compounding%2C%20do%20not%20address%20repackaging\">FDA Issues Final Guidance on Repackaging and Revised Draft Guidance on Mixing, Diluting, and Repackaging Biological Products <\/a><\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>US Department of Health and Human Services, Food and Drug Administration,\u00a0Center for Drug Evaluation and Research (CDER), Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities, Guidance for Industry, <a href=\"https:\/\/www.fda.gov\/media\/90978\/download\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.fda.gov\/media\/90978\/download<\/a><\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>United States Pharmacopeia:\u00a0 A Guide for the Compounding Practitioner<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>United States Pharmacopeia General Chapter &lt;795&gt;, Pharmaceutical Compounding\u2014Nonsterile Preparations<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p><strong>Revision History<\/strong><\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>Effective: 07\/2008<br>Revised: 12\/30\/2024<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t","protected":false},"parent":547,"template":"","class_list":["post-1132","dom","type-dom","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>3.5.18 Repackaging and Compounding Medications - Health Care Department Operations Manual (HCDOM)<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"3.5.18 Repackaging and Compounding Medications - Health Care Department Operations Manual (HCDOM)\" \/>\n<meta property=\"og:url\" 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