Pharmaceutical Compounding Chapter Revisions on Hold
But for how long, nobody knows.
Allergy, otolaryngology and primary care practices can breathe a sigh of relief, as the new Compounding Pharmacy USP standards set to go into effect Dec. 1, 2019, have been postponed as a result of appeals.
The revisions to Chapters <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations, as well as new Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging, are on hold until further notice.
General Chapter <800>, which describes requirements and responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and documentation, is still on track for implementation on Dec. 1, 2019.
Key topics covered in the appeals to <795> and <797> included:
- Beyond-Use Date (BUD) provisions in both chapters,
- Removal of Alternative Technology provision from <797>, and
- Applicability of and to veterinary practitioners in both chapters.
These standards affect medical practices that provide allergy serum because the mixing of the allergy serum is considered compounding pharmacy work. The sterile preparations outlined in the new standards are very detailed and overly burdensome for practices that only mix antigens and dilutant to create allergy immunotherapy.
For now, the USP will maintain the BUD framework for compounded nonsterile preparations in <795> and maintain provisions for compounded sterile preparations in <797>. The USP will also reinstate the Alternative Technology provision in <797>, which states:
“The use of technologies, techniques, materials, and procedures other than those described in this chapter is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described herein.”
Although reinstated, the USP says “the Alternative Technology provision is not intended to permit BUD extension or to extend the time during which single-dose containers may be used.”
At the Administrator Support Community for Ear Nose and Throat (ASCENT) Annual Meeting in Austin, Texas. Sept. 8-12, MedAllergy, a pharmacy that provides nondiluted allergenic extract, provided a summary of the new standards currently on hold:
- A designated person with training and expertise in allergen immunotherapy is responsible for ensuring that personnel who will be preparing allergen immunotherapy are trained, evaluated, and supervised.
- Before beginning to independently prepare allergen extracts, all compounding personnel must complete training and be able to demonstrate knowledge of theoretical principles and skills for sterile compounding.
- Annual personnel training and competency must be documented. Personnel must demonstrate proficiency in these procedures by passing a written or electronic test before they can be allowed to compound allergenic extract prescription sets.
- Before being allowed to independently compound, all compounders must successfully complete gloved fingertip and thumb sampling on both hands, no fewer than three separate times. Each fingertip and thumb evaluation must occur after performing separate and complete hand hygiene and garbing procedures. After the initial competency evaluation, compounding personnel must successfully complete gloved fingertip and thumb sampling at least every 12 months thereafter.
- Compounding personnel must have their sterile technique and related practices evaluated ever 12 months as demonstrated by successful completion of medial-fill test.
- Personnel who fail competency evaluations must successfully pass re-evaluation in the deficient area(s) before they can resume compounding of allergenic extract prescription sets. The designated person must identify the cause of failure and determine appropriate re-training requirements.
- Personnel who have not compounded an allergenic extract prescription in more than 6 months must be evaluated in all core competencies before resuming compounding duties.
Gloved and Fingertip and Thumb Sampling Procedures:
- Use one sampling device per hand (eg: plates, paddles or slides) containing general microbial growth agar (eg: trypticase soy agar (TSA)) supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth.
- Label each sampling device with a personnel identifier, whether it was from the right or left hand and the date and time of sampling.
- Do not apply sterile 70% isopropyl alcohol (IPA) to gloves immediately before touching the sampling device because this could cause a false-negative result.
- Use a separate sampling device for each hand, collect samples from all gloved fingers and thumbs from both hands by rolling fingers pads and thumb pad over the agar surface.
- Incubate the sampling device at temperature of 30-35 degrees Fahrenheit for no less than 48 hours and then at 20-25 degrees Fahrenheit for no less than five additional days. Store media devices during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (eg: invert plates)
- Record the number of cfu per hand (left hand and right hand)
- Determine whether the cfu action level is exceeding by counting the total number of cfu from both hands.
Gloved Fingertip and thumb sampling action levels:
Initial sampling after garbing: >0
Subsequent sampling after media-fill testing (every 6 months): >3
Media-Fill Testing Procedures:
- If all of the starting components are sterile to begin with, manipulate them in a manner that simulates sterile to sterile compounding activities and transfer the sterile soybean-casein digest media into the same types of container-closure systems commonly used at the facility. Do not further dilute the media unless specified by the manufacturer.
- If some of the starting components are nonsterile to begin with, use a nonsterile soybean-casein digest powder to make a solution. Dissolve nonsterile commercially available soybean-casein digest medium in nonbacteriostatic water to make a 3% nonsterile solution. Manipulate it in a manner that simulates nonsterile to sterile compounding activities. Prepare at least one container as then positive control to demonstrate growth promotion which is indicated by visible turbidity upon incubation.
- Once the compounding simulation is completed, the final containers are filled with test media, incubate them in incubator for seven days for 20-25 degrees Fahrenheit followed by seven days at 30-35 degrees F to detect a broad spectrum of microorganisms.
- Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container closure unit(s) on or before 14 days.
Personal Hygiene and Garbing:
- Before beginning compounding of allergen immunotherapy prescription sets, personnel must perform hand hygiene procedures and garbing procedures according to the facility Standard Operating Procedures (SOPs)
- The minimum garbing requirements include:
a. Low-lint garment with sleeves that fit snugly around the wrists and that is enclosed at the neck (eg: gowns or coveralls)
b. Low-lint disposable cover for head and that covers hair and ears and if applicable, disposable cover for facial hair
c. Face mask
d. Sterile, powder-free gloves
3. Compounding personnel must rub 70% IPA onto all surfaces of the gloves and allow them to dry thoroughly throughout the compounding process.
- The compounding process must occur in an ISO Class 5 PEC or in a dedicated allergenic extracts compounding area (AECA). The PEC or AECA used to compound prescription sets must be located away from unsealed windows, doors that connect to the outdoors and traffic flow, all of which may adversely affect air quality. Neither a PEC nor an AECA may be located where environmental challenges (eg: restrooms, warehouses or food preparation areas) could negatively affect air quality. The PEC or the work surfaces in the AECA must be located at least 1 meter away from a sink. The impact of activities that will be conducted around or adjacent to the PEC or AECA must be considered carefully when designing such an area.
a. If used, the PEC must be certified every 6 months
b. If used, a visible perimeter must establish the boundaries of the AECA.
i. Access to the AECA during compounding must be restricted to authorized personnel.
ii. During compounding activities, no other activity is permitted in the AECA.
iii. The surfaces of ceilings, walls, floors, fixtures, shelving, counters and cabinets in the AECA must be cleanable.
iv. Carpet is not allowed in the AECA.
v. Surfaces should be resistant to damage by cleaning and sanitizing agents.
vi. The surfaces in the AECA upon which the allergenic extract prescription sets are prepared must be smooth, impervious, free from cracks and crevices, and non-shedding to allow for easy cleaning and disinfecting.
vii. Dust-collecting overhangs such as utility pipes, ledges, and windowsills should be minimized. If overhangs or ledges are present, they should be easily cleanable.
viii. The AECA must be designed and controlled to provide a well-lighted working environment with temperature and humidity controls for the comfort of compounding personnel wearing the required garb.
Cleaning and Disinfecting:
- In a PEC, all interior surfaces of the PEC must be cleaned and disinfected daily and when surface contamination is known or suspected. Apply 70% IPA to the horizontal work surface between each prescription set.
2. In an AECA, all work surfaces in the AECA, where direct compounding is occurring must be cleaned and disinfected daily and when surface contamination is known or suspected. Apply 70% IPA to the horizontal work surface between each prescription set.
a. If present, walls, doors and door frames within the perimeter of the AECA must be cleaned or disinfected monthly and when surface contamination is known or suspected.
b. Ceilings within the AECA must be cleaned and disinfected when visibly soiled and when surface contamination is known or suspected.
3. Vial stoppers on packages of conventionally manufactured sterile ingredients must be wiped with 70% IPA to ensure that the critical sites are wet and allowed to dry before they are used to compound allergenic extracts prescription sets.
Establishing Beyond Use Dates (BUD):
- The BUD for the prescription set must be no later than the earliest expiration date of any allergenic extract or any diluent that is part of the prescription set, and the BUD must not exceed one year from the date the prescription set is mixed or diluted.
- The label of each vial of an allergenic extract prescription set must display the following prominently and understandably:
a. Patient name
b. Type and fractional dilution of each vial, with corresponding vial number
d. Storage condition
Shipping and Transport:
- If shipping or transporting allergenic extract prescription sets, compounding personnel must select modes of transport that are expected to deliver properly packed prescription sets in an undamaged, sterile and stable condition.Inappropriate transport can adversely affect the quality of the allergenic extract prescription sets.
- When shipping or transporting allergenic extract prescriptions that require special handling, personnel must include specific handling instructions on the exterior of the container.
- All facilities where allergenic extract prescription sets are prepared must have and maintain written or electronic documentation to include, but not limited to, the following:
a. SOPs describing all aspects of the compounding process
b. Personnel training records, competency assessments and qualification records including corrective actions for any failures
c. Certification reports of the PEC, if used including corrective actions for any failures
d. Temperature logs for the refrigerator(s)
e. Compounding records for any individual allergenic extract prescription sets
f. Information related to complaints and adverse events
g. Cleaning logs
h. Investigations and corrective actions
2. Compounding records must include at least the following information:
a. Name, concentration, volume, vendor or manufacturer, lot number and expiration date for each component
b. Date and time of preparation of allergenic extract
c. Assigned internal identification number
d. A method to identify of all individuals involved in the compounding process and verifying the final CSP
e. Total quantity compounded
f. Assigned BUD and storage requirements
g. Results of QC procedures (eg: visual inspection, second verification of quantities)
As plans and changes in the practice are made, it is important to keep in mind these pending revisions to the Compounding Pharmacy USP standards.
Allergy practices currently have a reprieve with the delay of the implementation of these updated rules. But with no date indicated as to when these rules will be put into effect with further review, allergy practices may be hit with these onerous rules at any time. Pay attention to notification of the rule changes.
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