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Learn about MassHealth Resources. The FDA recommends that all assay procedures for stability studies be stability indicating.
During stability studies, HPLC testing is used routinely to separate and quantitate the medication of interest. There are three components necessary for implementing an SIM: Sample generation is the easiest to accomplish whereas method development and validation are more difficult but achievable if given the necessary information. In order to understand this, one must first understand some of the terminology that is used. Potency testing , also known as quantitative tests, are designed to determine how much of the active drug is in the sample.
Stability testing is also concerned with potency. Methods of determining potency may or may not be stability indicating. Employing the proper method to determine potency or stability is the key to understanding the difference between potency testing and stability testing. Degradation testing is the gold standard of SIM.
Because of the cost, it is usually only done in a full-blown stability study. An alternative method has been to perform potency-over-time studies. Due to the expense, one independent laboratory may allow several hospitals within the same system to band together to decrease the initial cost of degradation studies. Examples are provided below of sample data points for particular medications. Note that these time points use data points past the desired length of time of the BUD to establish a trailing trend to validate the strength of the previous time points.
Establishment of a One-week Beyond-use Date A series of seven time points with multiple tests establishing the initial interaction should be used for testing to establish a BUD of one week initial or time zero, days 1, 2, 4, 6, 7, and 8. Adequate washing facilities, easily accessible to the compounding area s of the pharmacy shall be provided.
These facilities shall include, but not be limited to, hot and cold water, soap or detergent, and air dryers or single-use towels. Equipment used in the compounding of drug preparations shall be of suitable composition so that surfaces that contact components, in-process materials, or drug preparations shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug preparation beyond that desired. Immediately prior to the initiation of compounding operations, they must be inspected by the pharmacist and determined to be suitable for use.
If such equipment is used, it shall be routinely inspected, calibrated if necessary , or checked to ensure proper performance.
Stability of Drug - DYNALABS
This area shall be physically separate from other areas and should be designed to avoid unnecessary traffic and airflow disturbances. It shall be used only for the preparation of sterile parental preparations. A pharmacy compounding sterile parenteral preparations shall have the following minimum equipment and supplies: Infusion pumps, if appropriate; 3.
Sink, in working condition, with hot and cold running water, which is convenient to the compounding area for the purpose of hand scrubs prior to compounding; 4. Appropriate disposal containers for used needles, syringes, etc. A Class II, vertical flow biological safety cabinet or appropriate barrier isolator, if chemotherapy agents are routinely prepared; 7.
Class I or II electronic balance, or as approved in writing by the Board; 9. Disposable needles, syringes and other supplies needed for aseptic admixture; Disinfectant cleaning solutions; Handwashing agent with bactericidal action; Disposable, lint free towels or an automatic hand dryer; Appropriate filters and filtration equipment; Disposable masks and sterile, disposable gloves, gowns, hair and shoe covers and goggles when indicated; An oncology drug spill kit, if chemotherapy agents are routinely prepared. For the purpose of emergency or immediate patient care, compounded sterile preparations are exempted from the requirements as outlined in USP In addition to references required of a pharmacy, pharmacies compounding sterile pharmaceuticals shall also have a current edition of or electronic access to an established reference on IV stability and incompatibility, such as, Handbook on Injectable Drugs or King's Guide to Parenteral Admixtures, current Federal requirements for sterile compounding and other reference material including but not limited to: The reasons for the request for a variance must be included in the submitted request.
A variance shall be granted by the Board only when, in the judgment of the Board, there are sound reasons for doing so that relate to the necessary or efficient delivery of health care. After consideration by the Board, the requestor will be notified of the Board's decision in writing.
Stability of Drug
Such procedures shall include a listing of the components ingredients , their amounts in weight or volume , the order of component mixing, and a description of the compounding process. These written procedures shall be followed in the execution of the drug compounding procedure. Nothing in these rules shall prohibit or exclude the use of electronic or computer equipment to meet these requirements. These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight or measure is correct as stated in the written compounding procedures.
If a component is transferred from the original container to another e. Component name; and 2. Such control procedures shall be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final drug preparation. Such control procedures shall include, but are not limited to, the following where appropriate: Capsule weight variation; 2. Adequacy of mixing to assure uniformity and homogeneity; 3. Clarity, completeness, or pH of solutions.
Such procedures shall include validation of any sterilization process. The compounding record must document the following: The ingredients and amounts or volumes used including the source, lot numbers and expiration dates; 2.
The order of the mixing or preparation of the preparation including the date mixed; 3. The identity of the pharmacist and any staff member involved in each step of the procedure; and 4. The pharmacist must document in a readily retrievable manner, the following information: Components, drug preparation containers, and closures for use in the compounding of drug preparations shall be rotated so that the oldest stock is used first.
Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug preparation. Drug preparation containers and closures shall be clean and, where indicated by the intended use of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug preparation containers and closures used in the preparation of sterile pharmaceuticals.
These processes shall be performed by pharmacists or under the pharmacist's supervision. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of any such inspection. All records or reports must be producible immediately if requested by the Board or an agent of the GDNA or within forty-eight 48 hours if maintained in a central database. Appropriate samples of finished preparations shall be examined to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications.
Appropriate documentation and records shall be maintained. This process must include appropriate tests for particulate matter and testing for pyrogens. Email Us Live Chat. Articles recognized as drugs in any official compendium, or supplement thereto, designated from time to time by the Board for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;.
Articles, other than food, intended to affect the structure or any function of the body of humans or animals; and.
Articles intended for use as a component of any articles specified in subparagraph a , b , or c of this paragraph but does not include devices. Drug regimen review includes but is not limited to the following activities: Evaluation of any prescription drug order and patient record for: Reasonable dose and route of administration; and. Evaluation of any prescription drug order and patient record for duplication of therapy;.
Evaluation of any prescription drug order and patient record for the following interactions: Evaluation of any prescription drug order and patient record for proper utilization, including over utilization or under utilization, and optimum therapeutic outcomes.
Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures
Pharmacists shall receive, store, or use pharmaceuticals that have been manufactured or repackaged in a FDA-registered facility. All compounded preparations labeled in accordance with Board rules and regulations regarding pharmaceutical compounding shall be deemed to meet the labeling requirements of O. Compounded drug preparations - Pharmacist for Distribution to Practitioner a. Only a pharmacy licensed or registered by the Board may distribute compounded preparations to practitioners licensed in this state for administration to their patients in the course of their professional practice, either personally or by an authorized person under their direct and immediate supervision.
A practitioner shall make a request to the pharmacy for a compounded preparation in the same manner as ordering products from a wholesale pharmaceutical distributor or manufacturer and not by using a prescription drug order.
A pharmacy receiving an order from a practitioner for a compounded preparation shall maintain such order with its compounding records as required in Rule Pharmacists shall label all compounded preparations distributed to practitioners for administration to their patients with the following: The name of the active ingredients and strengths contained in the compounded preparation,.