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REGS : 10.34.09 Fees and 10.34.19 Sterile Compounding Preparations and Sterile Drug Products (BOARD OF PHARMACY)

 

 Content Editor

 
PROPOSAL
Maryland Register
Issue Date:  January 24, 2014
Volume 41 • Issue 2 • Pages 142—147
 
Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 34 BOARD OF PHARMACY
Notice of Proposed Action
[14-031-P]
The Secretary of Health and Mental Hygiene proposes to:
(1) Amend Regulation .02 under COMAR 10.34.09 Fees; and
(2) Amend Regulations .01, .03—.09, .11, .14, and .16, and adopt new Regulations .17—.21 under COMAR 10.34.19 Sterile Compounding Preparations and Sterile Drug Products.
This action was considered by the Board of Pharmacy at a public meeting held November 20, 2013, notice of which was given by publication on the Board of Pharmacy website, http://dhmh.maryland.gov/pharmacy/SitePages/Home.aspx, from October 30, 2013 ― November 20, 2013, pursuant to the State Government Article, §10-506(c), Annotated Code of Maryland.
Statement of Purpose
The purpose of this action is to:
(1) Add new fees for sterile compounding permits and for applications for a waiver for specified drug products under COMAR 10.34.09; and
(2) Revise COMAR 10.34.19 to accommodate H.B. 986, State Board of Pharmacy — Sterile Compounding — Permits, Ch. 397, Acts of 2013, which creates a new class of licensees.
The revisions include new definitions for “adverse events,” “compounding,” “designee,” “health care practitioner,” “risk level,” “sterile compounding,” “sterile compounding facility,” and “sterile drug product.” The following existing definitions were revised to accommodate H.B. 986: “clean room” and “compounded sterile preparation.” Regulations 01, .03 – .09, .11, .14, and .16 were revised to accommodate H.B. 986 striking the word “pharmacy” and substituting “sterile compounding facility.” Additionally, the word “pharmacist” has been stricken and substituted with the word “health care practitioner.” Other minor revisions were made to these sections to bring them in line with the new sterile compounding permit requirements. New Regulations .17 — .21 provide requirements for Sterile Compounding Permit Application Requirements, Minimum Requirements for Inspections of Sterile Compounding Permit Holders, Reporting Requirements for Sterile Compounding Permit Holders, Sterile Drug Products, and Sterile Drug Product Waivers.
Comparison to Federal Standards
There is a corresponding federal standard to this proposed action, but the proposed action is not more restrictive or stringent.
Estimate of Economic Impact
I. Summary of Economic Impact. In the fiscal note for S.B. 896/H.B. 986, Ch. 397, the Board indicated that the program would increase operations at the Board. In addition to its existing regulatory authority over sterile compounding pharmacies in Maryland, the Board will assume additional regulatory responsibilities to ensure the safety of non-resident sterile compounding pharmacies and sterile compounding facilities that perform sterile pharmaceutical compounding for Maryland patients.
The Board’s expenditures for FY 2014 are estimated to be $287,785.00 as a result of H.B. 986 State Board of Pharmacy — Sterile Compounding – Permits, 2013, Ch. 397, and these proposed regulations. During the first year of operations, the Board projects that it will be able to absorb start-up costs ($77,785.00) using funds available in its projected surplus and existing personnel and inspection resources. The training of existing management and inspection personnel to carry out some required functions will help absorb a portion of the costs. Also, performing dual inspections (related to the pharmacy permit and sterile compounding permit) during one annual visit to pharmacies that perform sterile compounding will defer costs related to the implementation of H.B. 986 State Board of Pharmacy — Sterile Compounding — Permits, Ch. 397, Acts of 2013.
The Board’s revenues may increase by as much as $210,000 in each of the next 5 years.
H.B. 986 State Board of Pharmacy — Sterile Compounding — Permits, 2013, Ch. 397, will require the Board to hire two Pharmacists III, Grade 18, Step 8, to do field inspections of compounding pharmacies. The two positions will require 2 new vehicles. The Board will also need to hire a Laboratory Scientist Surveyor I, Grade 16, Step 8, to work in-house to review compounding pharmacy applications and to review and interpret scientific reports from the compounding pharmacies to insure compliance. A Grade 8, Step 3, Office Services Clerk, will be needed to process the applications and issue compounding pharmacy permits. The Board has requested DHMH and DBM to take steps support the Board’s recruitment of staff in the positions to begin training no later than January 2014. Additionally, the impact on the Board’s on-going operating expenses include: requiring additional staff training, additional office space and equipment to accommodate new staff, additional configuration of the Board MIS system to allow application and tracking of permitted entities, and increases in staff and Board members’ workload time (comp/per diems) related to the implementation of H.B. 986 State Board of Pharmacy — Sterile Compounding — Permits, Ch. 397, Acts of 2013.
Expenses and revenues for implementing the new regulations are guesstimates only. The Board does not know how many types of sterile compounders are operating in Maryland. The Board’s projects 300 total entities to be regulated under this new license class based on approximately 100 pharmacies and 200 other entities (clinics, physicians, veterinarians, ophthalmologists, etc.) that may require a sterile compounding permit to operate in Maryland.
 
 
Revenue (R+/R-)
 
II. Types of Economic Impact.
Expenditure (E+/E-)
Magnitude
 

 
 
 
 
 
A. On issuing agency:
(1) Board of Pharmacy Expenditures
(E+)
$287.785
(2) Sterile compounding permits
(R+)
$210,000
(3) Sterile drug product waivers
(R+)
Indeterminable
B. On other State agencies:
NONE
 
C. On local governments:
NONE
 
 
 
Benefit (+)
Cost (-)
Magnitude
 

 
 
 
 
 
D. On regulated industries or trade groups:
(1) Sterile compounding facility permit
(-)
$210,000
(2) Application fee for a waiver for specified sterile
(-)
Indeterminable
E. On other industries or trade groups:
NONE
 
F. Direct and indirect effects on public:
(+)
Indeterminable
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
A(1). and D(1). The Board estimates that its expenditures will be $287,785 to implement this program taking into consideration the new positions, new vehicles and new licensure program.
A(2). The Board’s revenue will increase $210,000 each year if 300 sterile compounding facilities obtain a sterile compounding permit at $700 each. $700 x 300 = $210,000
A(3). and D(2). The fee for a sterile drug product waiver is $1,750 due to the expense of reviewing the application, inspections, and consideration of criteria by the Board and other health care professionals. However, it is unknown how many entities will apply for sterile drug product waivers.
F. There will be a benefit to the public because sterile compounded prescriptions and sterile drug products in Maryland will be prepared under strict USP 797 standards ensuring the safety and efficacy of these prescriptions and products.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele A. Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 W. Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 24, 2014. A public hearing has not been scheduled.
 
10.34.09 Fees
Authority: Health Occupations Article, §§12-205, 12-206, 12-302, 12-303, 12-305, 12-308, 12-310, 12-404, 12-407, 12-4A-02, 12-4A-04, 12-4A-05, 12-601, 12-6B-02, 12-6B-03, 12-6B-04, 12-6B-07, 12-6C-03, 12-6C-04, 12-6C-05, and 12-6C-06, Annotated Code of Maryland
.02 Fees.
The following fees are established by the Board:
A.—D. (text unchanged)
E. Sterile Compounding Permit Fees.
(1) Sterile compounding permit initial fee — $700;
(2) Sterile compounding permit renewal fee — $600; and
(3) Sterile compounding reinstatement fee (payable if renewal fee is received after January 31) — $600.
F. Sterile Drug Product Waiver Fees.
(1) Sterile drug product waiver application fee — $1,750;
(2) Sterile drug product waiver application fee for an additional sterile drug product for a person with an existing sterile drug product waiver — $700; and
(3) Sterile drug product waiver amendment fee — $700.
[E.] G. (text unchanged)
 
10.34.19 Sterile [Pharmaceutical] Compounding Preparations and Sterile Drug Products
Authority: Health Occupations Article, §§12-205, 12-4A -01 — 12-4A-11, 12-503, and 12-505, Annotated Code of Maryland
.01 Scope.
This chapter applies to a licensed pharmacy [in], sterile compounding facility, or other person dispensing or distributing sterile compounded preparations or sterile drug products into, out of, or within Maryland engaging in:
A.—B. (text unchanged)
.03 Definitions.
A. (text unchanged)
B. Terms Defined.
(1) “Adverse events” means:
(a) Any adverse patient outcome related to the sterile compounding process; or
(b) Evidence of environmental contamination, including microbial contamination above the threshold set forth in USP 797 Standards.
[(1)] (2)[(4)] (5) (text unchanged)
[(5)] (6) "Clean room" means a room with an ISO-5 environment or an International Standards Organization (ISO) Class 7 environment that meets USP 797 Standards, inside which compounding occurs within an ISO Class 5 engineering control device such as a laminar airflow workstation or a biological safety cabinet.
[(5-1)] (7) (text unchanged)
[(6)] (8) "Compounded sterile preparation" means sterile medication preparations, such as intravenous, epidural, and intraocular medications, compounded in the [pharmacy] sterile compounding facility using currently accepted aseptic compounding techniques under acceptable compounding conditions.
(9) “Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug only:
(a) As the result of a practitioner’s prescription drug order or initiative based on the practitioner/patient relationship in the course of professional practice; or
(b) For the purpose of, or incidental to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device; or
(c) In anticipation of a prescription drug order based on routine, regularly observed prescribing patterns.
[(7)] (10)[(9)] (12) (text unchanged)
(13) “Designee” means a public agency or private entity trained in USP 797 Standards and/or FDA good manufacturing practices approved by the Board to conduct inspections of sterile compounding facilities or entities that prepare sterile drug products.
(14) “Health Care Practitioner” means a licensed dentist, pharmacist, physician, podiatrist, or veterinarian who is authorized to perform sterile compounding for dispensing or administering directly to their patients.
[(10)] (15)[(15)] (20) (text unchanged)
(21) “Risk level” means a risk level of low, medium, or high as defined in USP 797 Standards.
[(16)] (22) (text unchanged)
(23) “Sterile compounding” means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797 Standards, are prepared using aseptic techniques.
(24) “Sterile compounding facility” means a pharmacy, a health care practitioner’s office, or any other setting in which sterile compounding is performed in a controlled environment as required by USP 797 Standards.
(25) “Sterile drug product” means a drug product that:
(a) Is prepared using aseptic techniques; and
(b) Is not required to be prepared in response to a patient specific prescription.
[(17)] (26)[(19)] (28) (text unchanged)
.04 [Pharmacy] Sterile Compounding Facility Environment.
The compounding, preparation, and dispensing of compounded sterile preparations shall be accomplished in a [pharmacy] sterile compounding facility environment subject to State and federal laws, regulations, and standards.
.05 General Requirements.
A licensed [pharmacist] health care practitioner who has [appropriate practical and didactic] training in compounding sterile preparations, clean room technology, laminar flow technology, quality assurance techniques, and clinical application of intravenous drug therapy shall control and supervise the section of the [pharmacy]

sterile compounding facility that prepares compounded sterile preparations and is responsible for, at a minimum, the following:
A. Preparation of compounded sterile preparations within the [pharmacy or pharmacy satellite] sterile compounding facility;
B. (text unchanged)
C. Labeling of containers of compounded sterile preparations compounded within the [pharmacy] sterile compounding facility;
D. Recording of transactions of the [pharmacy] sterile compounding facility as may be applicable to State and federal laws and regulations, as may be necessary to maintain accurate control over, and accountability for, pharmaceutical materials; and
E. Ensuring that licensed [pharmacists] health care practitioners meeting the requirements of §A of this regulation, or registered pharmacy technicians under direct supervision of a licensed pharmacist meeting the requirements of §A of this regulation, prepare, compound, and dispense compounded sterile preparations.
.06 Special Handling, Packaging, Labeling, and Beyond Use Dating.
A. The [pharmacy] sterile compounding facility shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous sterile preparations, during [delivery] handling, and before administration, to the patient including:
(1) (text unchanged)
(2) [Delivery from the pharmacy to the patient within a reasonable time; and
(3)] Proper in-transit storage consistent with preparation labeling[.] ; and
(3) For a sterile compounding facility that is a pharmacy, delivery to the patient within a reasonable time.
B. The dispensed container for any compounded sterile preparation shall include labeling according to Maryland law and regulations, in addition to the following information that is required by federal law:
(1)—(8) (text unchanged)
(9) The name or identifying initials of the [pharmacist] health care practitioner who checked or prepared the compounded sterile preparation unless otherwise readily retrievable from prescription records;
(10) The name, address, and telephone number of the [pharmacy] sterile compounding facility unless in an inpatient hospital facility;
(11)—(13) (text unchanged)
C. A [pharmacy] sterile compounding facility compounding sterile infusion preparations shall provide a 24-hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its [pharmacists] health care practitioners.
D. Expiration or Beyond-Use Dating. In the absence of direct testing evidence, as detailed in the Stability Criteria and Beyond Use Dating section of USP 795 Standards, the [pharmacist] health care practitioner shall use "beyond-use dating" as determined by USP 797 Standards and reference materials as cited in Regulation .16 of this chapter.
.07 Record-Keeping Requirements.
A. Patient Prescription Records.
(1) The [pharmacy] sterile compounding facility shall maintain records of patient prescriptions.
(2) Patient prescription records shall contain:
(a) Available medical information consistent with prevailing [pharmacy] sterile compounding standards; and
(b) (text unchanged)
(3) The [pharmacy] sterile compounding facility shall keep completed patient prescription records in a retrievable manner for at least 5 years[.], either:
(a) At the inspection site; or
(b) So as to be immediately retrievable by computer or other electronic means.
B. Compounded Sterile Preparations Records.
(1) For a [pharmacy] sterile compounding facility preparing compounded sterile preparations, the following records shall be maintained for at least 5 years:
(a)—(c) (text unchanged)
(d) Other facility quality control logs specific to the [pharmacy's] sterile compounding facility’s policies and procedures, for example, cleaning logs for facilities and equipment;
(e)—(f) (text unchanged)
(g) Preparation records including compounding work sheets and records of the [pharmacists'] health care practitioners’ checking/sign-off process.
(2) In addition to the records requirement in §B(1) of this regulation, for batch compounded sterile preparations, a [pharmacy] sterile compounding facility compounding sterile batch preparations for future use shall have records indicating the:
(a)—(e) (text unchanged)
(3) A [pharmacy] sterile compounding facility shall maintain records of media fill verification results for 5 years.
.08 Batch Preparation.
A. A [pharmacist] health care practitioner may prepare batched sterile preparations for future use in limited quantities supported by prior valid prescriptions or physician orders before receiving a valid written prescription or medication order.
B. Batch preparation of specific compounded sterile preparations is acceptable if the:
(1) [Pharmacist] Health care practitioner can document a history of valid prescriptions or physician orders that have been generated solely within an established professional [prescriber-patient-pharmacist] prescriber-patient-health care practitioner relationship; and
(2) [Pharmacy] Sterile compounding facility maintains the prescription on file for such preparations dispensed.
.09 Minimum Facility Requirements.
A. Controlled Environment.
(1) The [pharmacy] sterile compounding facility shall have a controlled environment that meets USP 797 Standards.
(2) A [pharmacist] health care practitioner shall ensure that the controlled environment is:
(a)—(b) (text unchanged)
(3) The permit holder shall ensure that the controlled environment is:
(a) Structurally isolated from other areas within the [pharmacy] sterile compounding facility by means of restricted entry or access; and
(b) (text unchanged)
B.D. (text unchanged)
.11 Minimum Requirements for Supplies.
A [pharmacy] sterile compounding facility engaging in compounding sterile preparations shall maintain adequate stock levels of the following supplies according to USP 797 Standards, including but not limited to:
A.—H. (text unchanged)
.14 Training of Staff, Patient, and Caregiver.
A. The [pharmacist] health care practitioner shall make counseling available to the patient or primary caregiver, or both, concerning proper use of compounded sterile preparations and related supplies furnished by the [pharmacy] sterile compounding facility.
B. The permit holder shall ensure that [pharmacy] sterile compounding facility personnel engaging in compounding sterile preparations are trained and demonstrate competence in the safe handling and compounding of compounded sterile preparations and parenteral solutions, including cytotoxic agents if applicable.
C. (text unchanged)
D. The permit holder shall ensure the continuing competence of [pharmacy] sterile compounding facility personnel engaged in compounding sterile preparations.
E. A [pharmacy] sterile compounding facility that compounds sterile preparations shall comply with the following training requirements:
(1) The [pharmacy] sterile compounding facility shall establish and follow a written program of training and performance evaluation designed to ensure that individuals working in the designated area have the knowledge and skills necessary to perform the assigned tasks properly and include at least the following:
(a)—(j) (text unchanged)
(2)—(3) (text unchanged)
.16 Reference Library.
Minimum reference materials in a [pharmacy] sterile compounding facility shall include:
A.C. (text unchanged)
.17 Sterile Compounding Permit Application Requirements.
A. A sterile compounding facility shall hold a sterile compounding permit issued by the Board before the sterile compounding facility may perform sterile compounding in the State.
B. A sterile compounding permit is required in addition to and does not replace any other permit or license a sterile compounding facility holds.
C. A sterile compounding facility that performs sterile compounding outside the State shall hold a sterile compounding permit issued by the Board before the sterile compounded preparations of the sterile compounding facility are dispensed in the State.
D. Minimum Application Requirements. To obtain a sterile compounding permit or renewal of a sterile compounding permit an applicant shall:
(1) Submit an application form approved by the Board that includes:
(a) Name;
(b) Address and contact information;
(c) Health care practitioner license number; and
(d) The highest USP 797 risk level of compounding engaged in by the applicant;
(2) Pay a fee as set forth in COMAR 10.34.09;
(3) Submit to an inspection which indicates compliance with USP 797 Standards, and conducted by:
(a) The Board;
(b) A designee of the Board; or
(c) The U.S. Food and Drug Administration;
(4) If an applicant is outside the State, obtain an inspection from a designee of the Board to demonstrate compliance with USP 797 Standards;
(5) Submit a statement of current compliance with USP 797 Standards;
(6) Submit reports and corrective actions taken or proposed in response to adverse events identified 12 months before submission of the application;
(7) Submit evidence that the sterile compounding facility employs at least one licensed health care practitioner who has training in compounding sterile preparations, clean room technology, laminar flow technology, quality assurance techniques, and clinical application of intravenous drug therapy;
(8) Submit evidence of good standing with:
(a) Any other State licensing entity; or
(b) The licensing entity in the state in which the applicant is located; and
(9) Submit any other documentation as required by the Board.
E. The applicant shall notify the Board in writing within 30 days of any change in the information given on the initial or renewal application.
F. A separate sterile compounding permit is required for each sterile compounding facility at which sterile compounding is performed.
G. A sterile compounding permit is not transferable.
H. Renewal.
(1) A sterile compounding permit expires on May 31 of the next even-numbered year after its effective date, unless the sterile compounding permit is renewed for a 2-year term as provided in this regulation.
(2) Before a sterile compounding permit expires, the sterile compounding permit may be renewed for an additional 2-year term if the applicant:
(a) Otherwise is entitled to the permit;
(b) Pays a renewal fee as set forth in COMAR 10.34.09; and
(c) Submits to the Board a renewal application on the form the Board requires.
.18 Minimum Requirements for Inspections of Sterile Compounding Permit Holders.
A. The Board shall inspect a sterile compounding permit holder at least annually.
B. The sterile compounding permit holder shall provide as part of the inspection process:
(1) Quality assurance testing reports;
(2) Documentation of reporting adverse events as required in this chapter;
(3) Microbial testing of a sampling of the sterile compounded preparations of the sterile compounding facility if applicable according to USP 797 Standards; and
(4) Any other information requested to ensure compliance with USP 797 Standards.
C. Inspections may be conducted by:
(1) A designee of the Board;
(2) The U.S. Food and Drug Administration; or
(3) Another appropriate state entity which indicates compliance with USP 797 Standards.
D. The Board may inspect a sterile compounding permit holder at any time to:
(1) Verify compliance with permit requirements; or
(2) Investigate a complaint.
.19 Reporting Requirements for Sterile Compounding Permit Holders.
A sterile compounding permit holder shall:
A. Document and perform routine testing as required by USP 797 Standards for the appropriate risk levels of sterile compounded preparations; and
B. Report to the Board within 5 calendar days:
(1) Adverse events including corrective actions taken or proposed;
(2) Deficiencies related to the sterile compounding process;
(3) Disciplinary actions in other states or by other state agencies;
(4) Changes in accreditation status;
(5) Disciplinary actions taken against a health care practitioner who is an owner, operator, or employee of the sterile compounding permit holder; and
(6) Disciplinary actions taken against any other known permit, or any other authorization, held by the sterile compounding permit holder.
.20 Sterile Drug Products.
A. A person that prepares and distributes sterile drug products into, out of, or within the State shall:
(1) Hold a manufacturer’s permit or other permit designated by the U.S. Food and Drug Administration to ensure the safety of sterile drug products; and
(2) Hold a wholesale distributor’s permit, if applicable, issued by the Board under Health Occupations Article, Title 12, Subtitle 6C, Annotated Code of Maryland.
B. A person that prepares and distributes sterile drug products into, out of, or within the State may not be required to hold a sterile compounding permit under Health Occupations Article, §12-4A-02, Annotated Code of Maryland.
.21 Sterile Drug Product Waiver.
A. The Board may issue a waiver of the requirements in Regulation .20A(1) of this chapter to a person that prepares and distributes sterile drug products into, out of, or within the State only:
(1) For a specified sterile drug product where exigent circumstances exist under the following criteria:
(a) The specified sterile drug product in the size and strength needed is:
(i) Listed on the current drug shortages index by the U.S. Food and Drug Administration or other nationally recognized index; or
(ii) Only prepared and distributed by the person applying for the waiver; and
(b) The absence of the specified sterile drug product would result in a patient care or a patient safety risk;
(2) For which there is a clinical need as determined by the Board with input from relevant professionals as determined by the Board;
(3) If the request for the waiver is not based on financial or business concerns; and
(4) If the applicant meets the following requirements:
(a) Submits an application form approved by the Board;
(b) Identifies in the application the highest USP 797 risk levels of compounding engaged in by the applicant;
(c) Pays a fee as set forth in COMAR 10.34.09;
(d) Submits reports of inspections conducted within a year of the application by:
(i) The Board or its designee; or
(ii) The U.S. Food and Drug Administration;
(e) Submits a statement of compliance with USP 797 Standards;
(f) Submits reports and corrective actions taken or proposed in response to adverse events identified 12 months before submission of an application for a waiver;
(g) If a pharmacy or a wholesale distributor shall employ at least one licensed pharmacist who has training in compounding sterile preparations, clean room technology, laminar flow technology, quality assurance techniques, and clinical application of intravenous drug therapy;
(h) Submits evidence of good standing with:
(i) Any other State licensing entity; or
(ii) The licensing entity in the state in which the applicant is located; and
(i) Submits any other documentation as required by the Board.
B. The Board shall, in its discretion, determine whether to issue a waiver based on the Board’s review of the information submitted in accordance with §A(1)—(4) of this regulation.
C. A person that prepares and distributes sterile drug products into, out of, or within the State under a Board-approved waiver shall submit to the Board within 5 calendar days reports of adverse events and corrective actions taken or proposed.
D. A person that prepares and distributes sterile drug products into, out of, or within the State under a Board-approved waiver shall notify the Board in writing within 30 days of any change in the information given on the initial or renewal application.
E. A person that prepares and distributes sterile drug products into, out of, or within the State under a Board-approved waiver shall submit reports of an inspection conducted:
(1) Within 1 year of the Board’s approval of the waiver that demonstrates compliance with USP 797 Standards; and
(2) By:
(a) The Board or its designee; or
(b) The U.S. Food and Drug Administration.
F. An applicant outside the State is responsible for obtaining an inspection from a designee of the Board to demonstrate compliance with USP 797 Standards.
G. Renewal. Any waiver issued by the Board may:
(1) Not exceed a duration determined by the Board based on exigent circumstances and clinical need;
(2) Not exceed 2 years; and
(3) Be renewed if the renewal applicant submits:
(a) An application form approved by the Board;
(b) A fee as set forth in COMAR 10.34.09; and
(c) Meets the requirements for a waiver under §A(1)—(3) of this regulation.
H. Documentation of Administration of Sterile Drug Products. The holder of a sterile drug product waiver shall ensure that the recipient of the sterile drug products maintain readily retrievable records of the administration and/or dispensing of the sterile drug products to patients, to include:
(1) Documentation of the lot number or other mechanism for identifying the sterile drug product for the purpose of tracing the sterile drug product back to the sterile compounding facility or other person that prepared it; or
(2) If documentation of the lot number or other identification mechanism is not feasible, documentation of the source of the sterile drug product for the purpose of tracking the sterile drug product back to the sterile compounding facility or other person that prepared it.
I. Amendments to the Waiver.
(1) The holder of a sterile drug product waiver shall submit amendments to the waiver in advance to the Board for approval, including the addition of a specified sterile drug product.
(2) The Board may approve amendments to the waiver if:
(a) The requirements of this chapter and Health Occupations Article, Title 12, Subtitle 4A, Annotated Code of Maryland, are met;
(b) The applicant submits any additional information requested by the Board; and
(c) Pays to the Board an amendment fee as set forth in COMAR 10.34.09.
JOSHUA M. SHARFSTEIN, M.D.
Secretary of Health and Mental Hygiene