Source: http://townhall.virginia.gov/L/ViewXML.cfm?textid=1480
Timestamp: 2019-07-23 10:01:08
Document Index: 491785511

Matched Legal Cases: ['§54', '§54', '§54', '§1471', '§54', '§54', '§54', '§54', '§1', '§54', '§ 54', '§54', '§54', '§54', '§54', '§54', '§54', '§54']

CH 0020 Conformity to compounding law
12/13/07 10:27 AM [latest] 11/30/07 2:59 PM
In addition to words and terms defined in §§54.1-3300 and 54.1-3401 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:
"Aseptic processing" means the technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.
"Beyond-use date" means the date beyond which the integrity of a compounded, repackaged, or dispensed drug can no longer be assured and as such is deemed to be adulterated or misbranded as defined in §§54.1-3461 and 54.1-3462 of the Code of Virginia.
"Class 100 environment" means an atmospheric environment which contains less than 100 particles, 0.5 microns in diameter, per cubic foot of air.
"Closed system transfer" means the movement of sterile products from one container to another in which the container-closure system and transfer devices remain intact throughout the entire transfer process, compromised only by the penetration of a sterile, pyrogen-free needle or cannula through a designated stopper or port to effect transfer, withdrawal, or delivery, to include the withdrawal of a sterile solution from an ampul in a class 100 environment.
"Cytotoxic drug" means a drug which has the capability of killing living cells.
"Electronic transmission prescription" is means any prescription, other than an oral or written prescription or a prescription transmitted by facsimile machine, that is electronically transmitted from a practitioner authorized to prescribe directly to a pharmacy without interception or intervention from a third party, or from one pharmacy to another pharmacy.
"Hermetic container" means a container that is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution.
"Home infusion pharmacy" means a pharmacy which compounds solutions for direct parenteral administration to a patient in a private residence, long-term care facility or hospice setting.
"Light-resistant container" means a container that protects the contents from the effects of light by virtue of the specific properties of the material of which it is composed, including any coating applied to it. Alternatively, a clear and colorless or a translucent container may be made light resistant by means of an opaque covering, in which case the label of the container bears a statement that the opaque covering is needed until the contents have been used. Where a monograph directs protection from light, storage in a light-resistant container is intended.
"Open-system transfer" means the combining of products in a nonsealed reservoir before filling or when a solution passes through the atmosphere during a transfer operation.
"Permitted physician" means a physician who is licensed pursuant to §54.1-3304 of the Code of Virginia to dispense drugs to persons to whom or for whom pharmacy services are not reasonably available.
"Quality assurance plan" means a plan approved by the board for continuous monitoring, measuring, evaluating, and, if necessary, improving the performance of a pharmacy function or system.
"Repackaged drug" means any drug removed from the manufacturer''s original package and placed in different packaging.
"Safety closure container" means a container which meets the requirements of the federal Poison Prevention Packaging Act of 1970 (15 USC §§1471-1476), i.e., in testing such containers, that 85% of a test group of 200 children of ages 41-52 months are unable to open the container in a five-minute period and that 80% fail in another five minutes after a demonstration of how to open it and that 90% of a test group of 100 adults must be able to open and close the container.
"Sterile pharmaceutical product" means a dosage form free from living microorganisms.
3. "Controlled room temperature" is means a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.
"Terminally ill" means a patient with a terminal condition as defined in §54.1-2982 of the Code of Virginia.
"Tight container" means a container that protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the drug, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure. Where a tight container is specified, it may be replaced by a hermetic container for a single dose of a drug and physical tests to determine whether standards are met shall be as currently specified in United States Pharmacopeia-National Formulary.
"Unit dose system" means a system in which multiple drugs in unit dose packaging are dispensed in a single container, such as a medication drawer or bin, labeled only with patient name and location. Directions for administration are not provided by the pharmacy on the drug packaging or container but are obtained by the person administering directly from a prescriber''s order or medication administration record.
§54.1-103 and 54.1-2400 and Chapters 33 (§54.1-3300 et seq.) and 34 (§54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Derived from VR530-01-1 §1.1, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 12, Issue 21, eff. August 7, 1996; Volume 15, Issue 8, eff. February 3, 1999; Volume 15, Issue 26, eff. October 13, 1999; Volume 16, Issue 21, eff. August 2, 2000; Volume 17, Issue 7, eff. January 17, 2001; Volume 20, Issue 23, eff. August 25, 2004; amended, Volume 24, Issue 8, eff. January 23, 2008.
The compounding of both sterile and nonsterile drug products shall be performed in accordance with USP-NF compounding standards and §54.1-3410.2 of the Code of Virginia.
§ 54.1-2400 and Chapter 34 of Title 54.1 of the Code of Virginia.
Derived from Virginia Register Volume 24, Issue 8, eff. January 23, 2008.
Compounding Sterile Pharmaceutical Products
18VAC110-20-411. General requirements. (Repealed.)
Products intended for parenteral administration or ophthalmic instillation shall be compounded using aseptic processing and in accordance with §54.1-3410.2 of the Code of Virginia.
§§54.1-2400 and 54.1-3309 of the Code of Virginia.
Derived from Virginia Register Volume 12, Issue 21, eff. August 7, 1996; amended, Virginia Register Volume 19, Issue 19, eff. July 2, 2003; repealed, Volume 24, Issue 8, eff. January 23, 2008.
18VAC110-20-412. Policy and procedure manual. (Repealed.)
A policy and procedure manual shall be prepared and maintained for the compounding, dispensing and delivery of sterile products that is consistent with USP-NF standards and guidance and shall include at least the following elements:
1. Personnel qualifications including initial and follow-up training and method of periodic reevaluation of qualifications and performance;
2. Scope of compounding performed at the pharmacy and proper procedures for compounding to include maintaining suitable environmental conditions in the compounding area, wearing appropriate garb to reduce particulate matter and contamination of work area, performing aseptic procedures.
3. Procedures for maintaining and monitoring proper operating conditions for all equipment used in sterile compounding;
4. Guidelines for patient or caretaker education if products are dispensed for home use to include instructions concerning proper storage, aseptic manipulation of the product, proper administration and use of devices if applicable, recognizing signs of instability or incompatibility, and procedures in case of an emergency with the product;
5. Guidelines for assignment of beyond-use dates for all compounded sterile products and justification for any date chosen which exceeds the standard set forth in this chapter;
6. Separate procedures for handling cytotoxic drugs, if applicable, to include protective apparel; disposal procedures consistent with applicable local, state, and federal requirements; procedures for handling spills; special packaging and labeling requirements, and delivery procedures to minimize risks of accidental spills;
7. If applicable, separate procedures for compounding sterile products using nonsterile components or open system transfer techniques and for end-product sterilization of these products.
§§54.1-103 and 54.1-2400 and Chapters 33 (§54.1-3300 et seq.) and 34 (§54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Derived from Virginia Register Volume 12, Issue 21, eff. August 7, 1996; amended, Virginia Register Volume 20, Issue 23, eff. August 25, 2004; repealed Volume 24, Issue 8, eff. January 23, 2008.
18VAC110-20-413. Physical and equipment requirements for pharmacies preparing sterile products. (Repealed.)
A. The sterile compounding area shall be of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies used in aseptic processing.
B. The sterile compounding area where parenteral products are routinely prepared shall be isolated from other areas and other pharmacy functions.
C. Sterile compounding shall be performed within a laminar flow hood or other appropriate environmental control device capable of maintaining, during normal activity, at least Class 100 conditions in the work area where sterile compounding is performed. Compounding of cytotoxic preparations shall be performed in a vertical flow Class II biological safety cabinet.
D. A pharmacy preparing sterile products shall maintain supplies adequate for the aseptic preparation of sterile products including, but not limited to, the following:
1. Antimicrobial soap;
2. Hot and cold water supply easily accessible to the sterile compounding area for hand washing prior to aseptic compounding;
3. Appropriate apparel for personnel performing sterile compounding;
4. Suitable disposal containers for used needles, syringes, etc. and, if applicable, containers for cytotoxic waste and infectious wastes.
E. A pharmacy preparing sterile products shall have sufficient current reference materials related to sterile products consistent with the policy and procedure manual and with the types of products prepared.
F. The pharmacy preparing sterile products shall have equipment necessary for maintaining and monitoring required temperature storage conditions both in the pharmacy and during delivery to the patient, if applicable.
§§54.1-2400, 54.1-3307, and 54.1-3312 of the Code of Virginia.
Derived from Virginia Register Volume 12, Issue 21, eff. August 7, 1996; repealed, Volume 24, Issue 8, eff. January 23, 2008.
18VAC110-20-414. Labeling requirements. (Repealed.)
A. In addition to other applicable labeling requirements for prescriptions as set forth in §54.1-3410 of the Code of Virginia and 18VAC110-20-260 B and 18VAC110-20-330, the label of a compounded sterile product shall include all active ingredient names, strengths, amounts, and concentrations, when applicable, and for IV infusion shall include the name of all solutions.
B. The label of a compounded parenteral sterile product shall include an appropriate beyond-use date and time, if applicable, and the required storage conditions to assure product integrity for that time period. Unless otherwise specified and justification provided in the policy and procedure manual, the expiration date for unpreserved sterile products prepared aseptically in a closed system for a single patient shall bear a maximum beyond-use date, including administration, as follows:
1. Twenty-eight hours if stored at controlled room temperature;
2. Seven days if stored under refrigeration; and
3. Thirty days if stored under freezing conditions.
C. The label of other compounded sterile products shall bear an appropriate beyond-use date, not to exceed 30 days from the date of preparation.
D. If the product is for home or other outpatient use, the label shall bear the prescribed administration regimen including rate and route of administration and any device specific instructions.
E. The label shall bear any appropriate auxiliary labeling, including precautions for cytotoxic drugs.
18VAC110-20-415. Quality assurance. (Repealed.)
A. The PIC in a pharmacy compounding sterile products shall be responsible for maintaining and updating the policy and procedure manual as set forth in 18VAC110-20-411 in accordance with current acceptable standards, and for ensuring compliance with the policy and procedure manual.
B. All laminar flow hoods or other environmental control devices shall be certified according to accepted standards for operational efficiency by a qualified independent contractor initially, at least every six months and after relocation.
Derived from Virginia Register Volume 12, Issue 21, eff. August 7, 1996; amended, Virginia Register Volume 20, Issue 23, eff. August 25, 2004; repealed, Volume 24, Issue 8, eff. January 23, 2008.
18VAC110-20-416. Records for sterile compounding. (Repealed.)
In addition to other required records, the following additional records shall be maintained for sterile compounding:
1. Compounding records maintained on or with the original prescription, or in a log format which can be cross-referenced with the prescription, or in an automated data processing system which contains the same information required in a manual system and is capable of producing a hard copy printout of a two-year history of prescription compounding and dispensing upon request within 72 hours. In addition to prescription information, the record must include the following information:
a. Date of sterile compounding;
b. Beyond-use date assigned to the sterile product; and
c. Signature, initials, or electronic identification of pharmacist compounding, or of both the nonpharmacist compounding and pharmacist checking the compounding of the sterile product.
2. Record documenting certification of clean room or laminar flow hoods.
3. If sterile products are provided to a patient''s residence, a record documenting training of the patient or caregiver, or both, in the proper storage and use of the product and any devices used to administer the devices.