SENATE RULES COMMITTEE | AB 377| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: AB 377 Author: Solorio (D) Amended: 8/6/12 in Senate Vote: 21 SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 9-0, 6/13/11 AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete McLeod, Vargas, Walters, Wyland SENATE APPROPRIATIONS COMMITTEE : 6-0, 8/13/12 AYES: Kehoe, Walters, Alquist, Lieu, Price, Steinberg NO VOTE RECORDED: Dutton ASSEMBLY FLOOR : 70-0, 5/12/11 (Consent) - See last page for vote SUBJECT : Pharmacy SOURCE : California Hospital Association DIGEST : This bill authorizes a centralized hospital packaging pharmacy to prepare medications, by performing specified functions for administration only to inpatients within its own general acute care hospital, or one or more general acute care hospitals under the same ownership and located within 75 miles of each other. ANALYSIS : Existing law: CONTINUED AB 377 Page 2 1. Provides for the practice of pharmacy and the licensing and regulation of pharmacies and pharmacists by the Board of Pharmacy (Board) within the Department of Consumer Affairs. 2. Defines "hospital pharmacy" as a pharmacy licensed by the Board, located within any licensed hospital, institution or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay. 3. Provides that "hospital pharmacy" also includes a pharmacy that may be located outside of the hospital, in another physical plant that is regulated under a hospital's consolidated license issued by the Department of Corrections and Rehabilitations or Department of Youth Authority. Specifies that the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the hospital is located. Specifies that the pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. 4. State that any pharmacy that contracts to compound a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy, must report that contractual arrangement to the Board within 30 days of commencing that compounding. This bill: 1. This bill allows a centralized hospital packaging pharmacy to prepare medications for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other. 2. Authorizes a centralized hospital to perform the following specialized functions if each unit dose is AB 377 Page 3 barcoded as specified: A. Preparing unit dose packages for single administration to inpatients from bulk containers. B. Preparing compounded unit dose drugs for parenteral therapy for administration to inpatients. C. Preparing compounded unit dose drugs for administration to inpatients. 3. Defines "common ownership" to mean that the ownership information on file with the Board for the licensed pharmacy is consistent with the ownership information on file for the other licensed pharmacy or pharmacies. 4. Requires, in addition to pharmacy license requirement described in current law, a centralized hospital packaging pharmacy to obtain a specialty license from the Board prior to engaging in the functions authorized by this bill. 5. Requires the Board, before issuing and renewing the specialty license, to inspect the pharmacy and ensure that the pharmacy is in compliance with this bill and regulations it has established. 6. States a license to perform the functions described in this bill shall only be issued to a pharmacy that is licensed by the Board as a hospital pharmacy, and that the license shall be renewed annually and is not transferrable. 7. Sets the fee for issuance or annual renewal of a centralized hospital packaging pharmacy license at $600 and allows it to be increased by the Board to $800. 8. Allows a centralized hospital packaging pharmacy to prepare and store a limited quantity of the unit dose drugs in advance of receipt of a patient-specific prescription in a quantity as is necessary to ensure continuity of care for an identified population of inpatients of the general acute care hospital based on a AB 377 Page 4 documented history of prescriptions for that patient population. 9. Requires any unit dose medication produced by a centralized hospital packaging pharmacy to be barcoded to be readable at the inpatient's bedside. Upon reading the barcode, the following information shall be retrievable: A. The date the medication was prepared. B. The components used in the drug product. C. The lot number or control number. D. The expiration date. E. The National Drug Code Directory lot number. F. The name of the centralized hospital packaging pharmacy. 10.Requires the label for each unit dose medication produced by a centralized hospital packaging pharmacy to contain all of the following: A. The expiration date. B. The established name of the drug. C. The quantity of the active ingredient. D. Special storage or handling requirements. 11.Requires all compounding and packaging functions be performed only in the licensed centralized hospital packaging pharmacy and that pharmacy shall comply with all applicable federal and state statutes and regulations, including, but not limited to, regulations regarding compounding and, when appropriate, sterile injectable compounding. 12.Requires a centralized hospital packaging pharmacy and the pharmacists working in the pharmacy be responsible AB 377 Page 5 for the integrity, potency, quality, and labeled strength of any unit dose drug product prepared by the centralized hospital packaging pharmacy. Background Existing law requires medications for a hospital's patients to be prepared by a licensed pharmacy located on the hospital's premises. Automated processes implemented by a hospital or health system have the potential to provide additional patient protection through a reduction in medication errors. Many medication errors in hospitals have resulted from inadequate and inconsistent labeling and a lack of proper mechanisms to track medication through the distribution process to the patient. Recent reports show that technology like bar-coding facilitates more efficient medication administration and decreases medication errors. According to a study published in the New England Journal of Medicine, "Effect of Bar-Code Technology on the Safety of Medication Administration," use of the bar-code substantially decreased the rate of errors as well as potential adverse drug events. The report also concluded that the bar-code electronic medication administration is an important intervention to improve patient safety. Food and Drug Administration (FDA). Repackaging, distribution, and compounding in advance of a patient prescription are activities currently available only to licensed manufacturers, which are regulated by the United States FDA. Last year, in an email pertaining to a Virginia hospital using a model as proposed in this bill, which is virtually identical to AB 2077 (Soloria, 2010), the FDA stated that "Ýthe proposed health facility pharmacy] system does not need to register as a repacker/relabeler as long as they are servicing their own hospitals within the state of California and repackaged drugs are not commercially distributed and used only within your hospital facilities." While there has not been an official change in FDA policy, it is clear in the FDA's Compliance Policy Guide (460.200) as follows: "FDA will continue to defer to state authorities regarding pharmacy compounding of human drugs." Board Compounding Regulations . New regulations governing AB 377 Page 6 compounding took effect last summer. According to the Board, a Workgroup on Compounding was formed in 2004 comprised of board members, Board staff and industry representatives. The workgroup recognized that current pharmacy regulations addressing compounding only govern the physical circumstances, procedures and record keeping requirements for general compounding and do not address quality, strength or purity. The Board adopted regulations in Article 7 of Division 17 of Title 16 of the California Code of Regulations (commencing with Section 1751) to implement provisions for pharmacies that compound sterile injectable products as required in statute. As there were no similar provisions in regulation for general compounding, the Board approved the addition of language that will establish parameters and provide uniformity for pharmacies that carry out compounding in general (including sterile injectable). Pharmacies that compound sterile injectable products must go above and beyond the requirements for compounding in general. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes According to the Senate Appropriations Committee, minor costs annually to the Board from the Pharmacy Board Contingent Fund, offset by fees. Potentially major costs annually to the Department of Public Health from the Licensing and Certification Program Fund. SUPPORT : (Verified 8/14/12) California Hospital Association (source) AmerisourceBergen Board of Pharmacy California Pharmacists Association California Society of Health-System Pharmacists Los Angeles County Mercy Sharp University of California, San Francisco School of Pharmacy AB 377 Page 7 ASSEMBLY FLOOR : AYES: Achadjian, Allen, Ammiano, Atkins, Beall, Bill Berryhill, Block, Blumenfield, Bonilla, Bradford, Brownley, Buchanan, Butler, Charles Calderon, Campos, Carter, Chesbro, Cook, Davis, Dickinson, Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani, Beth Gaines, Galgiani, Gatto, Gordon, Grove, Hagman, Halderman, Hall, Harkey, Hayashi, Hill, Huber, Hueso, Huffman, Jeffries, Jones, Knight, Lara, Logue, Ma, Mansoor, Mendoza, Miller, Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan, Perea, V. Manuel Pérez, Silva, Skinner, Smyth, Solorio, Swanson, Valadao, Wagner, Wieckowski, Williams, Yamada, John A. Pérez NO VOTE RECORDED: Alejo, Cedillo, Conway, Garrick, Gorell, Roger Hernández, Bonnie Lowenthal, Mitchell, Portantino, Torres JJA:do 8/14/12 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Showing posts with label California. Show all posts
Showing posts with label California. Show all posts
Monday, August 20, 2012
California Senate Rules Committee: Proposed Law Regarding Compounding At Centralized Hospital Packaging Pharmacy
Thursday, July 19, 2012
Update on Changes to Regulations in California Relating to Compounding
The 15-day comment period for the proposed changes to compounding regulations in California expires July 30, 2012. The notice of proposed action can be found here. The proposed Compounding Self-Assessment Form can be find here. The Initial Statement of Reasons for the Changes can be found here. The notice of modified text can be found here. The modified proposed language can be found here.
Prior post on changes to California regulations relating to compounding can be viewed here.
Prior post on changes to California regulations relating to compounding can be viewed here.
Instruction and Form for Filing for Application for Sterile Compounding Pharmacy Licence in Califorinia
The form for filing for application to compound injectable sterile drug in California is found here. The form details who may compound injectable sterile drug products in California:
Chapter 9, of Division 2 of the Business and Professions Code and regulations adopted
by the board." The form also contains the following warning: "All pharmacies that compound injectable sterile drug products must follow board regulations for sterile compounding. These regulations are found in Title 16 of the California Code of Regulations as Article 8, beginning with section 1751." A $600 fee is required with the application. Both a state and federal background check are required.
A pharmacy that is specially licensed with the board as a sterile compounding pharmacy, or a pharmacy that is operated by an entity that is licensed by the board or the State Department of Health Services and has a current accreditation from the Joint Commission on Accreditation of Healthcare Organizations or another accreditation agency approved by the board. The following private accreditation agencies have been approved by the board:
The form explains that "[a} license to compound injectable sterile drug products may not be issued until the location is inspected by the board and found to be in compliance with Article 7.5 ofAccreditation Commission for Health Care, Inc. (ACHC) through February 2014,Community Health Accreditation Program (CHAP) through February 2014,
Det Norske Veritas (DNV) through July 2013,
Pharmacy Compounding Accreditation Board (PCAB) through February 2014, or
American Osteopathic Association Healthcare Facilities Accreditation Program
(HFAP) through February 2014.
Chapter 9, of Division 2 of the Business and Professions Code and regulations adopted
by the board." The form also contains the following warning: "All pharmacies that compound injectable sterile drug products must follow board regulations for sterile compounding. These regulations are found in Title 16 of the California Code of Regulations as Article 8, beginning with section 1751." A $600 fee is required with the application. Both a state and federal background check are required.
Friday, June 29, 2012
In California One of Common Errors is Incorrect NDC codes for Compounded Drugs
License Renewal
Processing Delayed
Atlantic Associates, Inc., the CURES data collection
vendor, has identified to the Board the four most often
occurring reporting errors. Pharmacies are entering:
1. Invalid NDC numbers;
2. Incorrect NDC codes for compounded
formulations: They should be entering the NDC
code for the main active ingredient and identifying
the prescription as a compounded drug; and
3. Invalid prescriber DEA numbers.
4. Pharmacies are also failing to enter the Method of
Payment: Cash, Medicaid/Medi-Cal, Medicare,
Commercial Insurance, Major Medical, or
Workman’s Compensation.
To ensure proper data collection, those who are
responsible for making CURES entries must make every
effort to enter valid and accurate information.
List found here.
Beware of drug transfer dealers that are not California-licensed Wholesalers
The following warning appeared in the March 2012 California Board of Pharmacy Newsletter:
Frequently, pharmacies find themselves with near-expired
drugs, partially full containers of drugs, and drugs that are
rarely dispensed and unlikely to be dispensed in the near
future. The pharmacies may return such drugs to the wholesaler
they purchased them from or to a reverse distributor, and less
frequently to the manufacturer itself. Sometimes a pharmacy may
be partially reimbursed for the cost of the drugs or charged a fee
for destroying the drugs.
Some California pharmacies, seeking to reduce their
inventory of such drugs have become involved with out-of-state
companies who solicit membership in their online business,
which allows members to post their requests to buy, sell, bid on,
or trade unwanted drugs to other members. One such company
assures that becoming a member and using their services will
increase the pharmacies’ profits by 50 percent. However, all
the parties to such transactions may be violating
Rule Regarding Patient-Centered Labels for Prescription Drugs Now in Effect in California
The new rule in California provides:
1707.5. Patient-Centered Labels for Prescription Drug
Containers; Requirements
(a) Labels on drug containers dispensed to patients in California
shall conform to the following format:
(1) Each of the following items shall be clustered into one
area of the label that comprises at least 50 percent of the
label. Each item shall be printed in at least a 10-point
sans serif typeface or, if requested by the consumer, at
least a 12-pooint typeface, and listed in the following
order:
(A) Name of the patient
(B) Name of the drug and strength of the drug. For the
purposes of this section, “name of the drug” means
either the manufacturer’s trade name of the drug, or
the generic name and the name of the manufacturer.
(C) The directions for the use of the drug.
(D) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated
on the prescription.
(2) For added emphasis, the label shall also highlight in
bold typeface or color, or use blank space to set off the
items listed in subdivision (a)(1).
(3) The remaining required elements for the label specified
in section 4076 of the Business and Professions Code,
as well as any other items of information appearing on
the label or the container, shall be printed so as not to
interfere with the legibility or emphasis of the primary
elements specified in paragraph (1) of subdivision (a).
These additional elements may appear in any style, font,
and size typeface.
To read remainder of new rule, click here.
Sunday, May 27, 2012
California Guidance Regarding Compounding
The state of California has a website that contains specific questions and answers regarding the compounding laws and regulations in that state. Click here to read that guidance.
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