Case law in Iowa Regarding Compounding: Houck v. Iowa Board of Pharmacy Examiners

HOUCK v. IOWA BOARD OF PHARMACY EXAMINERS

 

Garvis G. HOUCK, Appellant, v. IOWA BOARD OF PHARMACY EXAMINERS, Appellee.

No. 06-1747.

-- June 27, 2008

Michael M. Sellers of Sellers Law Office, West Des Moines, for appellant.Thomas J. Miller, Attorney General, and Scott M. Galenbeck, Assistant Attorney General, for appellee.

A pharmacist compounded and sold a product to a customer without a prescription.   The customer filed a complaint with the administrative agency that regulates the conduct of pharmacists, and a sanction was imposed against the pharmacist.   In this appeal from the district court's ruling affirming the agency's action, we must decide whether the agency has authority to designate the compounded product as a drug that may be dispensed by a pharmacist only if it has been prescribed by a practitioner.   We conclude the agency acted within its broad authority, and therefore affirm the district court's ruling.

I. Factual and Procedural Background.

Garvis Houck is a licensed Iowa pharmacist and the owner-operator of Houck Drug, a licensed Iowa pharmacy in Clear Lake. In 2002 Shirley Meyer consulted Houck about nasal irritation.   After offering to supply a product to ease Meyer's symptoms, Houck compounded ¹ a nasal spray containing a mixture of:  2-deoxy-d-glucose (an antiviral);  dyclonine (an anesthetic);  miconazole (an antifungal);  methylcellulose (a suspending agent);  sodium chloride;  and distilled water.   Each of these substances was, by itself, a nonprescription drug.   Houck sold the compounded product to Meyer in a bottle that was not labeled with a prescription number, a prescriber's name, or a pharmacist's initial on the label.   Meyer used the nose drops once, experienced increased nasal irritation, and filed a complaint with the Iowa Board of Pharmacy Examiners (“board”).

The board assigned an investigator, Jacky Devine, to investigate Meyer's complaint.²  Houck admitted he compounded the nasal spray for Meyer without a prescription based on his experience in compounding some of the same substances for prescribers in the area.   While conducting the investigation of the Meyer complaint, Devine found several violations of pharmacy regulations that had been noted in a prior inspection.   Houck was unable to produce for Devine forms required to record transactions involving narcotics,³ a required log for permanent and nonpermanent pharmacist employees, compounding production records bearing the initials of the compounding pharmacist, and a logbook containing the initials of pharmacists who provided customers certain cough syrups containing codeine.   Houck had been warned about all of these record-keeping deficits in 2000.

The board filed two charges against Houck based on the investigation of the Meyer transaction and the 2002 inspection:  (1) intentional or repeated violation of the board's rules regarding operation of a pharmacy and maintenance of controlled substance records;  and (2) unlawful manufacturing and dispensing of a compounded drug without a prescriber's authorization.   Following a hearing, the board issued a written decision finding Houck committed the alleged violations and placed Houck and Houck Drug on probation for three years with several conditions.   The board specifically ordered Houck to refrain from compounding of any kind without authorization from a prescriber.

Houck sought judicial review in the district court.   He contended the regulations prohibiting pharmacists from compounding, without a prescription, substances separately available without a prescription are unconstitutional.   Houck also asserted the board lacked authority to issue the regulations, and the board's disciplinary action was not supported by substantial evidence.   The district court denied Houck's petition.

II. Scope of Review.

On judicial review of final agency action, we review for errors at law.  Hough v. Iowa Dep't of Pers., 666 N.W.2d 168, 170 (Iowa 2003).   In determining the appropriate scope of review of an agency's interpretation of a statute, the crucial question for the reviewing court is whether the interpretation of the statute has clearly been vested by a provision of law in the agency's discretion. See Iowa Code § 17A.19(10)(c ), (l ).   If the agency has been clearly vested with interpretive authority, we generally defer to the agency's interpretation, and may grant relief only if the agency's interpretation is “irrational, illogical, or wholly unjustifiable.”   Id. § 17A.19(10)(l ).   If the agency has not been clearly vested with discretion to interpret the statute, “we are free to substitute our judgment de novo for the agency's interpretation and determine if the interpretation is erroneous.”  Auen v. Alcoholic Beverages Div., 679 N.W.2d 586, 589-90 (Iowa 2004) (citing Iowa Code § 17A.19(10)(c )).

The legislature has delegated broad authority to the Board of Pharmacy Examiners for the regulation of the practice of pharmacy in Iowa. Iowa Code section 147.76 (2007) ⁴ confers upon the board the authority to “adopt all necessary and proper rules to implement and interpret [chapter 155A].” See also Iowa Code § 155A.3(3) (stating the term “board” in chapter 155A refers to the board of pharmacy examiners).   We have previously held similar language in other statutes constituted a clear vesting in the agency of the authority to interpret a statute.  Thoms v. Iowa Pub. Employees' Ret. Sys., 715 N.W.2d 7, 11 (Iowa 2006) (finding a clear vesting of interpretive authority where a statute directed the agency to “adopt ․ rules ․ and take other action it deems necessary for the administration of the retirement system”);  Auen, 679 N.W.2d at 590 (holding grant of authority to an agency to adopt rules “necessary to carry out this chapter” clearly vested in the agency authority to interpret a statute);  City of Marion v. Iowa Dep't of Revenue & Fin., 643 N.W.2d 205, 207 (Iowa 2002) (holding statute providing “[t]he director shall have the power and authority to prescribe all rules not inconsistent with the provisions of this chapter, necessary and advisable for its detailed administration and to effectuate its purposes,” vested authority in the department of revenue and finance to interpret section 422.45(20)).  Section 147.76 clearly vests the board of pharmacy examiners with authority to interpret chapter 155A. We will therefore overturn the board's interpretation of that chapter only if it is “irrational, illogical, or wholly unjustifiable.”  Iowa Code § 17A.19(10)(l ).

We review an agency's factual findings for substantial evidence based on the record viewed as a whole.  Id. § 17A.19 (10)(f).   Substantial evidence is

the quantity and quality of evidence that would be deemed sufficient by a neutral, detached, and reasonable person, to establish the fact at issue when the consequences resulting from the establishment of that fact are understood to be serious and of great importance.

Id. § 17A.19(10)(f)(1).

We review constitutional claims de novo.  Wright v. Iowa Dep't of Corr., 747 N.W.2d 213, 216 (Iowa 2008).

III. Discussion.

A. Board's Authority to Regulate Compounding of Nonprescription Drugs.

1. Board's authority to define “prescription drugs.”   The primary controversy in this case centers on the board's interpretation of Iowa Code section 155A.3(35).   This statute defines a “prescription drug” as any of the following:

a.  A substance for which federal or state law requires a prescription before it may be legally dispensed to the public.

b. A drug or device that under federal law is required, prior to being dispensed or delivered, to be labeled with one of the following statements:

(1) Caution:  Federal law prohibits dispensing without a prescription.

(2) Caution:  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Caution:  Federal law restricts this device to sale by, or on the order of, a physician.

(4) Rx only.

c. A drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only, or is restricted to use by a practitioner only.

Iowa Code § 155A.3(35) (emphasis added).   The board has interpreted subsection (c ) as a positive grant of authority by the legislature to the board to enact regulations requiring that certain drugs be dispensed on prescription only.   Relying on such authority, the board enacted rule 20.2, a rule which, in relevant part, prohibits a pharmacist from dispensing compounds consisting of exclusively nonprescription components without a prescription from a practitioner.⁵  Iowa Admin.   Code r. 657-20.2. Rule 20.2 thus brings a compound made from exclusively nonprescription components within the definition of a “prescription drug” in section 155A.3(35)(c ).   Houck contends section 155A.3(35)(c ) does not vest the board with the authority to designate as a “prescription drug” a compounded substance consisting of a combination of nonprescription substances.

After carefully reviewing chapter 155A in light of the board's authority to implement and interpret that chapter, we cannot say the board's interpretation of section 155A.3(35)(c ) as a positive grant of authority to the board to designate all compounded substances as “prescription drugs” is irrational, illogical, or wholly unjustifiable.   The plain language of section 155A.3(35)(c ) clearly evidences legislative intent to identify, at least in part through state administrative rule, those substances which may be dispensed by pharmacists only if prescribed by a practitioner.   As we have already noted, the board has been vested with broad authority to adopt rules to “implement and interpret” chapter 155A. Iowa Code § 147.76. The board is the agency charged with administering Iowa Code chapter 124 (“Controlled Substances”) and Iowa Code chapter 126 (“Iowa Drug, Device, and Cosmetic Act”).   Id. §§ 124.101(3), .201, .301;  126.2(3), .17.   The board asserts, and Houck does not dispute, that no other state administrative agency is assigned regulatory power over controlled substances or prescription drugs.   We conclude the board's interpretation of section 155A.3(35)(c ) as a statutory authorization to identify prescription drugs by administrative rule is not irrational, illogical, or wholly unjustifiable.   It is an interpretation that gives reasonable and logical meaning to the words “or regulation” in the statute.   See T & K Roofing Co. v. Iowa Dep't of Educ., 593 N.W.2d 159, 162 (Iowa 1999) (noting interpretations that render a portion of a statute redundant or irrelevant should be avoided).

Houck contends the general assembly enumerated in chapter 124 the list of drugs which may be regulated as “prescription drugs” under chapter 155A. According to Houck, the board's only authority to influence what is a “prescription drug” is its role in recommending to the general assembly the appropriate classification for controlled substances in chapter 124.   Iowa Code § 124.201. Chapters 124 and 155A, however, do not narrowly limit the board's authority to regulate prescription drugs in the manner suggested by Houck.

As averred by Houck, chapter 124 lists five categories, or schedules, of “controlled substances.”   See generally id. §§ 124.203-.212. As the term is used in chapter 124, a “controlled substance” is “a drug, substance, or immediate precursor in schedules I through V of division II of this chapter.”   Id. § 124.101(5).   The schedules categorize various substances according to their relative potential for abuse, the degree to which the substance has an accepted medical use, and likelihood that abuse of the substance would lead to psychic or physical dependence.  Id. § 124.201. Contrary to Houck's assertion, however, chapter 124 does not define “prescription drug”;  nor does it purport to present an exhaustive list of substances which may be only dispensed by a pharmacist pursuant to a practitioner's prescription.   We find no limitation in chapter 124 on the board's authority to define “prescription drugs.”

Our rejection of Houck's contention that chapter 124 limits the board's authority to define “prescription drugs” is strengthened by the careful distinctions drawn by the general assembly in chapter 155A between “controlled substances” and “prescription drugs.”   A “prescription drug” may be either a “drug” or “device.” ⁶  Id. § 155A.3(35)(c ).   A “drug” is any of the following:

a. A substance recognized as a drug in the current official United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia, or other drug compendium or any supplement to any of them.

b. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.

c. A substance, other than food, intended to affect the structure or any function of the body of humans or other animals.

d. A substance intended for use as a component of any substance specified in paragraph “a ”, “b ”, or “c ”.

e. A controlled substance.

Id. § 155A.3(13) (emphasis added).   As in chapter 124, the term “controlled substance” in chapter 155A refers to the substances or precursors to the substances listed in the chapter 124 schedules.  Id. § 155A.3(6).   Thus, in chapter 155A the terms “drug” and “prescription drug” are not limited to the substances in the controlled substance schedules.   Although the legislature has granted the board only the limited authority to recommend to the general assembly substances to be designated as “controlled substances,” id. § 124.201, no such limitation appears in section 155A.3(35)(c) in connection with the board's authority to define “prescription drugs.”

2. Validity of the board's compounding rule.   Having found the board could rationally conclude it had the authority to require a drug to be dispensed by prescription only, we must determine whether the board's compounding rule is irrational, illogical, or wholly unjustifiable.   Houck contends the relevant portion of the rule is irrational because it forbids pharmacists, who have special training regarding interactions between drugs, from combining and distributing compounds consisting exclusively of substances available without a prescription while allowing nonpharmacists to do so.   We disagree.   The board's inclusion of all compounded substances within the definition of “prescription drug” is sufficiently related to the goals of chapter 155A to survive our scrutiny under the applicable deferential standard of judicial review.

Rule 20.2 is properly within the bounds of the board's authority under section 155A.3(35).   As noted above, that statute requires a “prescription drug” be a “drug or device.”  Id. § 155A.3(35)(c ).   A “drug” includes “[a] substance, other than food, intended to affect the structure or any function of the body of humans.”  Id. § 155A.3(13)(c ).   The product compounded by Houck for Meyer easily fits within this definition of “drug.”   Rule 20.2 promulgated by the board expressly confines the definition of compounding to “preparing, mixing, assembling, packaging, and labeling a drug or device for an identified individual patient․” Iowa Admin.   Code r. 657-20.2 (emphasis added).   Because the rule applies only to compounded “drugs” and “devices,” it is firmly within the board's authority to require that drugs or devices be dispensed on prescription only.

A rational and logical connection exists between the rule and the board's duties under chapter 155A. The purpose of chapter 155A is “to promote, preserve, and protect the public health, safety, and welfare through the effective regulation of the practice of pharmacy․” Iowa Code § 155A.2. The board asserts it enacted rule 20.2 in order to draw a bright line between the practice of medicine and the practice of pharmacy.   Generally speaking, the practice of medicine involves the intake of patients, diagnosis of illnesses, and prescription of treatment, while the practice of pharmacy primarily consists of preparing and dispensing medications.   By requiring the “prescriber/patient/pharmacist” relationship as a prerequisite to the dispensing of compounded drugs by pharmacists, the board has exercised administrative discretion to prohibit pharmacists from diagnosing illnesses and prescribing treatment for their customers-functions traditionally undertaken by doctors.   The board could rationally and logically have concluded this exercise of discretion clearly separating the pharmacist function from that of the prescriber advances the health, safety, and welfare of pharmacists' customers.

Our confidence in the conclusion the board's rule is neither illogical nor unreasonable is not diminished by the fact that it does not preclude nonpharmacists from compounding nonprescription substances.   Nonpharmacists are not licensed to dispense drugs, and do not hold themselves out as experts in compounding substances sold to treat health problems suffered by human beings.   As a consequence, there is no significant market for the compounding services of nonpharmacists.   Pharmacists, on the other hand, are licensed and widely regarded by their customers as experts who reliably dispense drugs manufactured by others or compounded by them.   The board could logically and rationally conclude the substantial market for the compounding services of pharmacists justifies regulation, and the nonexistent demand for compounding services by nonpharmacists does not.   Furthermore, chapter 155A grants the board no authority to regulate the activities of nonpharmacists.

Houck correctly posits that pharmacists are not prohibited by statute or agency rule from recommending nonprescription medications to customers who describe their symptoms and seek advice.   He relies on this fact to support his contention that the board does not truly draw the line between pharmacy and medicine at “diagnosing” and “prescribing.”   Even if we acknowledge the apparent plausibility of Houck's contention, however, we conclude it does not undermine the board's authority to prohibit compounding of drugs without a prescription or render rule 20.2 irrational.   The board could rationally conclude, as it did, that compounding of substances-including “drugs” not enumerated as controlled substances under chapter 124 and consisting entirely of “over-the-counter” components-by pharmacists without a prescription for the treatment of maladies or symptoms presented by customers poses risks to the public health, safety, and welfare.   Accordingly, rule 20.2 is not rendered invalid as a consequence of the board's failure to require a prescription for the dispensing by pharmacists of “over-the-counter” drugs manufactured by others.

3. Constitutional challenge.   Houck also contends the board's regulation violates the equal protection clauses of the federal and Iowa Constitutions because it unfairly discriminates against pharmacists with respect to compounding of nonprescription substances.   See U.S. Const. amend.   XIV;  Iowa Const. art. I, § 6. Houck is a licensed pharmacist, and is therefore not similarly situated to a non-pharmacist.   The legislature may therefore treat him differently than a non-pharmacist.   See In re Det. of Hennings, 744 N.W.2d 333, 339 (Iowa 2008) (noting dissimilar treatment of persons not similarly situated does not offend equal protection).   Because he has failed to demonstrate dissimilar treatment of similarly situated individuals, Houck's equal protection challenge to the board's rule is without merit.

B. Noncompounding Violations.   Houck also broadly asserts the factual findings underlying the board's decision to sanction him for the other, noncompounding violations were not supported by substantial evidence.   While asserting the board made its findings of fact “based solely on its compliance officer's report regarding arguable and meaningless minor violations” of administrative rules, and that the violations were the result of a “hyper-technical application” of administrative rules, Houck does not actually assail the substantiality of the evidence supporting the facts found by the board.   Upon a careful review of the record, we find ample support for the board's finding that Houck engaged in a “pattern of choosing which rules to follow and which rules to ignore.”   The board's findings are supported by substantial evidence.

C. Sanction. We have previously noted the limited scope of judicial review of sanctions imposed by administrative agencies.   When a “licensing board is made up of members of the profession they are licensing, the court should not second guess the board's decision” as to the appropriate sanction.  Burns v. Bd. of Nursing of Iowa, 528 N.W.2d 602, 605 (Iowa 1995).   The pharmacy board is primarily constituted of pharmacists, see Iowa Code § 174.14(5), and we see no basis in the record to depart from this sound rule.   We accordingly uphold the board's findings that Houck's serial violations of administrative rules warranted the imposition of a three-year probation.

IV. Conclusion.

We find the board could have rationally concluded the general assembly delegated to it the authority to designate drugs compounded by pharmacists as “prescription drugs” to be dispensed only if prescribed by a practitioner.   The rule adopted by the board consistent with that authority is not irrational, illogical, or wholly unjustifiable.   The board's adoption of that rule and enforcement of it against Houck did not deprive him of equal protection of the law.   The board's factual findings are supported by substantial evidence in the record.

AFFIRMED.

FOOTNOTES

1.   The Iowa Administrative Code defines “compounding” as “preparing, mixing, assembling, packaging, and labeling a drug or device for an identified patient․” Iowa Admin.   Code r. 657-20.2.

2.   Devine had investigated for the board a similar complaint against Houck in October of 2000.   That complaint also arose as a consequence of Houck's compounding of “over-the-counter” substances without a prescription.   Devine found Houck's records to be out of compliance in several particulars with the board's regulations at that time, and warned Houck against compounding and selling substances without a prescription.

3.   Houck later provided Devine with most, but not all, of the missing forms.

4.   The events giving rise to this case occurred in 2002.   Accordingly, the statutes controlling our disposition were codified in the 2001 Iowa Code. Those statutes were renumbered and relocated in the code without substantive change after 2001.   The parties have uniformly cited those statutes as they appear in the 2007 Code, and we will do so as well.

5.   The Iowa Code defines a “practitioner” asa physician, dentist, podiatric physician, veterinarian, or other person licensed or registered to distribute or dispense a prescription drug or device in the course of professional practice in this state or a person licensed by another state in a health field in which, under Iowa law, licensees in this state may legally prescribe drugs.Iowa Code § 155A.3(33).

6.   A “device” is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a practitioner.”   Iowa Code § 155A.3(10).   This case does not involve a “device,” and we therefore consider only the portion of the statute pertaining to “drugs.”

HECHT, Justice.

All justices concur except BAKER, J., who takes no part.

New Jersey Proposed Rules Regarding Compounding

The following are the proposed rules in New Jersey, last updated May 31, 2012, relating to  Compounding Sterile and Non-Sterile Preparations in Retail and Institutional Pharmacies: RULE PROPOSAL VOLUME 44, ISSUE 3 ISSUE DATE: FEBRUARY 6, 2012 LAW AND PUBLIC SAFETY DIVISION OF CONSUMER AFFAIRS STATE BOARD OF PHARMACY Pre-Proposed Amendments: N.J.A.C. 13:39-11.1 and 11.2 Pre-Proposed Repeals and New Rules: N.J.A.C. 13:39-11.3, 11.11, 11.15, and 11.19 Pre-Proposed New Rules: N.J.A.C. 13:39-11.8, 11.9, 11.14, 11.18, and 11A Pre-Proposed Repeals: N.J.A.C. 13:39-11.4, 11.21, and 11.23 through 11.27 Pre-Proposed Recodification with Amendments: N.J.A.C. 13:39-11.5 as 11.12, 11.6 as 11.13, 11.7 as 11.16, 11.8 as 11.17, 11.9 as 11.20, 11.10 as 11.21, 11.12 as 11.22, 11.13 as 11.23, 11.14 as 11.24, 11.16 as 11.4, 11.17 as 11.5, 11.18 as 11.7, 11.20 as 11.6, and 11.22 as 11.10 Notice of Pre-Proposal Compounding Sterile and Non-Sterile Preparations in Retail and Institutional Pharmacies Authorized By: State Board of Pharmacy, Edward G. McGinley, R.Ph., President. Authority: N.J.S.A. 45:14-47 and 48. Pre-Proposal Number: PPR 2012-001. Take notice that the State Board of Pharmacy (Board) is considering proposing amendments and new rules governing the compounding of sterile and non-sterile preparations in both retail and institutional [page=203] pharmacy practice settings. The Board undertook a review of its existing compounding rules, set forth in N.J.A.C. 13:39-11, following the publication of the latest revisions to the United States Pharmacopeia's (USP) General Chapter 797 - Pharmaceutical Compounding of Sterile Preparations. USP 797 establishes practice standards designed to ensure that compounded sterile preparations are of high quality in order to prevent patient harm. As part of this review, the Board also examined the practice standards established in USP's General Chapter 795 - Pharmaceutical Compounding of Nonsterile Preparations. The Board believes that extensive amendments to the existing rules in Subchapter 11, as well as several new rules, are necessary to ensure that the Board's rules are consistent with the Federal best practice standards established in USP 797 and 795. The Board notes that although the existing requirements in Subchapter 11 apply to both the compounding of sterile and non-sterile preparations, the pre-proposed amendments and new rules divide the requirements for sterile and non-sterile preparations into separate subchapters to ensure clarity. Comments on the pre-proposed amendments and new rules should be sent by April 6, 2012 to: Anthony Rubinaccio, Executive Director Board of Pharmacy P.O. Box 45013 Newark, New Jersey, 07101 Full text of the rules pre-proposed for repeal may be found in the New Jersey Administrative Code at N.J.A.C. 13:39-11.3, 11.4, 11.11, 11.15, 11.19, 11.21, and 11.23 through 11.27. Full text of the pre-proposed amendments and new rules follows (additions indicated in boldface thus; deletions indicated in brackets [thus]): SUBCHAPTER 11. COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES [FOR STERILE AND/OR NON-STERILE PREPARATIONS] 13:39-11.1 Purpose and scope [This] The rules in this subchapter regulate the practice of sterile compounding and shall apply to all retail and institutional pharmacies which compound and dispense sterile [and/or non-sterile] preparations. This subchapter establishes standards for the quality and control of processes, components, and environments associated with compounded sterile preparations, and for the skill and knowledge of pharmacy personnel who prepare compounded sterile preparations. 13:39-11.2 Definitions The following words and terms, when used in this subchapter, shall have the following meanings: "Ante area" means an ISO class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, labeling, and other high-particulate-generating activities are performed. The "ante area" is also a transition area that: 1. Provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and 2. Reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to respond to large disturbances. "Biological safety cabinet" means a ventilated cabinet for compounded sterile preparations that has an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhaust air for environmental protection. "Buffer area" means an ISO class 7 area where the primary engineering control is physically located and where the preparation and staging of components and supplies used in compounding sterile preparations occurs. "Cleanroom" means a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness (ISO) class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class. A "cleanroom" includes a buffer area or room and an ante area or room. "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner's prescription or medication order or initiative based on the relationship of the practitioner or the patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescriptions or medication orders based on routine, regularly observed prescribing patterns. Compounding includes mixing, reconstituting, or assembling a drug according to the product's labeling or to the manufacturer's directions. "Compounding aseptic containment isolator" means a compounding aseptic isolator designed to provide worker protection from exposure to undesirable levels of airborne hazardous drugs throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter (high-efficiency particulate air (HEPA) minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded. "Compounding aseptic isolator" means a form of isolator specifically designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer process. Air exchanges into the isolator from the surrounding environment should not occur unless the air has first passed through a microbially retentive filter (high-efficiency particulate air (HEPA) minimum). "Immediate use compounded sterile preparations" means preparations intended for emergency patient care and involve only simple aseptic measuring and transfer manipulations of no more than three sterile non-hazardous commercial drug and diagnostic radiopharmaceutical drug products, including an infusion or diluent solution. Unless required for the preparation, the compounding process occurs continuously without delays or interruptions and does not exceed one hour. Administration of immediate use compounded sterile preparations shall begin within one hour of preparation or the compounded sterile preparations shall be discarded. Immediate use compounded sterile preparations shall not be compounded and stored for anticipated needs and shall not be compounded as batch preparations. At no time during the compounding process nor prior to administration are critical sites and ingredients of the compounded sterile preparation directly exposed to contact contamination such as human touch, cosmetic flakes or particulates, blood, human body substances and non-sterile inanimate sources. "ISO class 5 air quality conditions" means conditions in which the air particle count is no greater than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air (100 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air. ["ISO class 6 air quality conditions" means conditions in which the air particle count is no greater than a total of 35,200 particles of 0.5 micrometers and larger per cubic meter of air (1,000 particles per cubic foot).] "ISO class 7 air quality conditions" means conditions in which the air particle count is no greater than a total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air (10,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air. "ISO class 8 air quality conditions" means conditions in which the air particle count is no greater than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air (100,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air. "Negative pressure room" means a room that is at a lower pressure than the adjacent spaces and, therefore, the net airflow is into the room. [page=204] "Positive pressure room" means a room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room. "Primary engineering control" means a device or room that provides an ISO class 5 environment for the exposure of critical sites when compounding sterile preparations. Such devices include laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators. "Risk levels for compounded sterile preparations" means the established classification for compounded sterile preparations based on the potential for microbial, chemical and physical contamination of the preparations, and are defined as follows: 1. "Low-risk level compounded sterile preparations" means preparations compounded with aseptic manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products, components, and devices. The compounding process involves only assembling, transferring, measuring, and mixing, using no more than three commercially manufactured sterile products, and not more than two entries into one sterile container or package to make the compounded sterile preparations. The compounding process is limited to aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing. 2. "Medium-risk level compounded sterile preparations" means preparations compounded under low-risk level conditions but which require multiple individual or small doses of sterile products to be combined or pooled to prepare compounded sterile preparations that will be administered either to multiple patients or to one patient on multiple occasions. The compounding process includes complex aseptic manipulations other than single volume transfer, and requires unusually long duration, such as that required to complete dissolution or homogeneous mixing. 3. "High-risk level compounded sterile preparations" means preparations compounded from non-sterile ingredients or from ingredients which are incorporated using non-sterile equipment before terminal sterilization, or from commercially manufactured sterile products that lack effective antimicrobial preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality worse than ISO class 5 for more than one hour. Water containing preparations which are stored for more than six hours before terminal sterilization are also classified as high-risk level compounded sterile preparations. 13:39-11.3 Application and pre-approval requirements for compounding sterile preparations (a) An applicant for a new pharmacy who wishes to compound sterile preparations shall satisfy all pharmacy permit application requirements set forth in N.J.A.C. 13:39-4.1. As part of the permit application, the applicant shall submit plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. An applicant for a pharmacy permit shall not dispense sterile preparations compounded at this site until receiving written approval from the Board to engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection of the pharmacy to ensure compliance with the requirements in this subchapter. (b) The holder of an existing pharmacy permit who wishes to compound sterile preparations shall submit an amended pharmacy permit application to the Board. The amended permit application shall contain plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. The holder of an existing pharmacy permit shall not dispense sterile preparations compounded at this site until receiving written approval from the Board to engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection of the pharmacy to ensure compliance with the requirements in this subchapter. (c) A pharmacy permit holder who is approved to compound sterile preparations shall notify the Board at least 60 days in advance of any remodeling, change of location, or change in size of the pharmacy cleanroom, consistent with the requirements of N.J.A.C. 13:39-4.7. Such notification shall include the pharmacy's remodeling or relocation plans, as appropriate, the pharmacy's interim plans for the continuation of sterile compounding operations, which the Board shall review and approve, and the anticipated date of completion. The pharmacy permit holder and the pharmacist-in-charge shall ensure compliance with all requirements set forth in this subchapter while compounding operations continue during the remodeling or relocation process. The pharmacy permit holder shall notify the Board upon completion of the remodeling or relocation process, at which time the Board shall inspect the premises. (d) A pharmacy holding an institutional permit that is approved to compound sterile preparations and that intends to compound sterile preparations using a laminar air flow workbench not located in a buffer area, as provided in N.J.A.C. 13:39-11.10, shall notify the Board at least 60 days in advance of its intention and of all locations where such equipment will be installed. The pharmacy permit holder shall notify the Board upon completion of such installation, at which time the Board shall inspect the equipment. The pharmacy shall not utilize such equipment to compound sterile preparations until receiving Board approval. (e) A pharmacy permit holder who is approved to compound sterile preparations and who intends to utilize compounding aseptic isolators or compounding aseptic containment isolators not located in a buffer area, as provided in N.J.A.C. 13:39-11.8, shall notify the Board at least 60 days in advance of its intention and of all locations where such equipment will be installed. The pharmacy permit holder shall notify the Board upon completion of such installation, at which time the Board shall inspect the equipment. The pharmacy shall not utilize such equipment to compound sterile preparations until receiving Board approval. 13:39-[11.16]11.4 [Controlled environment for compounded sterile preparations:] Cleanroom; use, access, location; temperature; air pressure (a) The pharmacy shall have a designated area for sterile preparation compounding, known as the ["controlled environment," consisting of a clean room and an anteroom unless the pharmacy meets the requirements of N.J.A.C. 13:39-11.22 or 11.23.] "cleanroom." A cleanroom shall be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. Critical sites are locations that include any component or fluid pathway surfaces (for example, vial septa, injection ports, beakers) or openings (for example, opened ampuls, needle hubs) exposed and at risk of direct contact with air (for example, ambient room or HEPA filtered), moisture (for example, oral and mucosal secretions), or touch contamination. A cleanroom shall include a buffer area and an ante area. The buffer area shall contain an ISO class 5 or better primary engineering control, such as a laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, and/or compounding aseptic containment isolator, unless the buffer area has ISO class 5 or better air quality. (b) All sterile compounding shall take place within the confines of the buffer area, except for the following: 1. Compounding in a compounding aseptic isolator or a compounding aseptic containment isolator pursuant to N.J.A.C. 13:39-11.8; 2. Compounding in a laminar airflow workbench in an institutional pharmacy pursuant to N.J.A.C. 13:39-11.10; and 3. Compounding immediate use compounded sterile preparations in an institutional pharmacy pursuant to N.J.A.C. 13:39-11.11. [(b)] (c) A [controlled environment] cleanroom shall be: 1. Accessible only to designated personnel; 2. Used only for the compounding of sterile preparations, or such other tasks that require a [controlled environment] cleanroom; 3. Structurally isolated from other areas within the pharmacy by means of restricted entry or access; and [page=205] 4. Air conditioned to maintain a temperature of 59 to 77 with an ideal temperature of 66 degrees Fahrenheit. (d) A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity, respectively, consistent with the following: 1. For compounding of non-hazardous drugs, if the buffer area and the ante area are physically separated through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02 inch to 0.05 inch water column shall be required. For buffer areas not physically separated from the ante area, the principle of displacement airflow shall be employed. Using displacement airflow, an air velocity of 40 feet per minute or more from the buffer area across the line of demarcation into the ante area is required. 2. For compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed in an ISO class 7 buffer area that is physically separated from other preparation areas and has not less than 0.01 inch water column negative pressure to adjacent positive pressure ISO class 7 or better ante room, thus providing inward airflow to contain any airborne drug. 3. For compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall be physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch water column and have a minimum of 12 air exchanges per hour. (e) No chewing gum, drinks, candy, or food items shall be brought into the cleanroom. 13:39-[11.17]11.5 [Controlled environment for compounded sterile preparations: construction] Cleanroom requirements (a) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the [controlled environment] cleanroom shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby minimizing spaces in which microorganisms and other contaminants may accumulate. (b) Work surfaces shall be constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that the work surfaces may be readily cleaned and sanitized. All work surfaces shall be resistant to damage from cleaning and sanitizing agents. (c) Junctures where ceilings meet walls shall be covered, caulked, or sealed to avoid cracks and crevices [where dirt] in which microorganisms and other contaminates can accumulate. All areas in ceilings and walls where the surface has been penetrated shall be sealed. (d) Ceilings which consist of inlaid panels shall be impregnated with a polymer to render them impervious and hydrophobic and shall either be caulked or weighted and clipped. (e) [Solid walls] Walls shall [consist either] be constructed of flexible material (for example, heavy gauge polymer), panels locked together and sealed, or of epoxy-coated gypsum board. (f) Floors shall have vinyl floor covering and shall be seamless or have heat-welded seams and coving to the sidewall. There shall be no floor drains. (g) There shall be no dust-collection overhangs (such as ceiling utility pipes) [or] and ledges (such as window sills) should be avoided. All sprinkler heads shall be flush with the ceiling. (h) Ceiling lighting fixtures shall have exterior lens surfaces which are smooth, mounted flush, and air tight. [(i) All areas in ceilings and walls where the surface has been penetrated shall be sealed.] (i) Carts shall be of stainless steel wire, nonporous plastic, or sheet metal construction with good quality, cleanable casters to promote mobility. [(j) Any clean room construction other than that specified in (a) through (i) above (for example, softwall, prefabricated, modular, portable clean rooms) shall be approved by the Board prior to installation and use.] (j) Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to ensure the integrity of the compounded sterile preparations, consistent with the requirements of N.J.A.C. 13:39-11.12(b)3. 13:39-[11.20]11.6 [Controlled environment for compounded sterile preparations: anteroom] Ante area requirements (a) The [anteroom] ante area shall have [an air quality of ISO class 7 or better] appropriate environmental control devices capable of maintaining ISO class 8 air quality conditions for non-hazardous drug compounding activities, and ISO class 7 air quality conditions for hazardous drug compounding activities as provided in N.J.A.C. 13:39-11.4(d)2. (b) The [anteroom] ante area shall contain the following equipment: 1. A sink with hot and cold running water with an integrated and closed plumbing system; 2. Waste containers for all personal protective equipment; 3. An eyewash station; and 4. A hazardous waste spill kit. [(c) A refrigerator, as required by United States Pharmacopoeia Standards, shall be reasonably accessible to the anteroom to ensure the integrity of the compounded sterile preparations, but shall not be located within the controlled environment.] 13:39-[11.18]11.7 [Controlled environment for compounded sterile preparations: stocking, maintenance and supplies] Buffer area requirements (a) The buffer area shall have appropriate environmental control devices capable of maintaining ISO class 7 air-quality conditions during normal activity consistent with the requirements of N.J.A.C. 13:39-11.4(d). [(a)] (b) The [controlled environment] buffer area shall contain only the following: 1. Items such as furniture, equipment, supplies, and other [goods] materials which are required for the tasks to be performed there; 2. Items which are nonpermeable, nonshedding, cleanable, and resistant to disinfectants; and 3. Items which have been cleaned and [sanitized] disinfected immediately prior to their being placed in the [clean room] buffer area. [(b)] (c) [Whenever possible, equipment] Equipment and other items used in the [controlled environment should] buffer area shall not be taken from these [rooms] areas except for calibration, servicing, or other [activity] activities associated with the proper maintenance of the item. [(c)] (d) The [controlled environment] buffer area shall be kept clean and arranged in an orderly fashion. All required equipment shall be maintained in good operating condition. [(d)] (e) The [controlled environment] buffer area shall not be used for bulk storage, warehousing, or clerical and secretarial functions. [(e) The controlled environment area shall contain the following supplies: 1. Gloves, masks, gowns, and other personal protective equipment; 2. Needles and syringes of various sizes; 3. Disinfectant cleaning agents; 4. Clean towels; 5. Hand-washing materials, including antimicrobial skin cleaner; and 6. Any and all supplies necessary for the aseptic compounding of sterile preparations.] (f) The buffer area shall not contain any sinks. (g) The buffer area shall be a minimum of 100 square feet in size and shall be compatible with the volume of compounding being conducted. (h) The buffer area shall contain waste containers in compliance with Occupational Safety and Health Administration (OSHA) standards for disposal of used needles and syringes set forth in 29 CFR § 1910.1030 and for disposal of chemotherapy waste set forth at 29 CFR § 1910.1200, incorporated herein by reference, as amended and supplemented, and available at www.osha.gov. [page=206] 13:39-11.8 Use of compounding aseptic isolators and compounding aseptic containment isolators located outside of a cleanroom A pharmacy may utilize compounding aseptic isolators and compounding aseptic containment isolators not located in a cleanroom to prepare compounded sterile preparations, provided the compounding aseptic isolators and compounding aseptic containment isolators can provide isolation from the room and maintain ISO class 5 air quality during dynamic operating conditions, including transferring ingredients, components, and devices into and out of the isolator and during preparation of compounded sterile preparations. A pharmacy utilizing a compounding aseptic containment isolator not located in a cleanroom to compound antineoplastic agents and other hazardous substances shall comply with the requirements of N.J.A.C. 13:39-11.4(d)3. Particle counts sampled approximately six to 12 inches upstream of the critical exposure site must maintain ISO class 5 air quality levels during compounding operations. Compounding personnel shall obtain documentation from the manufacturer that the compounding aseptic isolator or compounding aseptic containment isolator will meet this standard when located in worse than ISO class 7 environments. A compounding aseptic isolator and compounding aseptic containment isolators not located in a buffer area shall be located in an area that is maintained under sanitary conditions and such area shall only be traveled by persons engaging in the compounding of sterile preparations. 13:39-11.9 Compounding of antineoplastic agents and other hazardous substances (a) For purposes of this section, hazardous substances are those substances identified as hazardous by the National Institute for Occupational Safety and Health (NIOSH) in Appendix A of NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The sample list of drugs that shall be handled as hazardous is incorporated herein by reference, as amended and supplemented, and can be found at the Centers for Disease Control and Prevention website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/2004-165d.html#o. (b) Pharmacies shall not prepare antineoplastic agents and other hazardous substances as immediate use compounded sterile preparations. (c) Pharmacies shall compound antineoplastic agents and other hazardous substances only in: 1. A compounding aseptic containment isolator or a Class II or Class III biological safety cabinet in a negative pressure cleanroom. When handling volatile hazardous drugs, such devices shall be vented to the outside air; or 2. A compounding aseptic containment isolator located outside of a negative pressure cleanroom, consistent with N.J.A.C. 13:39-11.8. When handling volatile hazardous drugs, such devices shall be vented to the outside air. (d) Correct room pressurization shall be maintained at all times when compounding antineoplastic agents and other hazardous substances, consistent with N.J.A.C. 13:39-11.4(d). (e) Personnel who compound and dispense antineoplastic agents and other hazardous substances shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs. OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by NIOSH in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH standard is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/. (f) Antineoplastic agents and other hazardous substances used to compound sterile preparations shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. Such storage is preferable within a containment area such as a negative pressure room. The storage area shall have sufficient general exhaust, at least 12 air exchanges per hour to dilute and remove any airborne contaminants. Antineoplastic agents and hazardous substances used to compound sterile preparations shall be handled with caution using appropriate chemotherapy gloves during distribution, receiving, stocking, inventorying, preparing for administration, and disposal. 13:39-[11.22]11.10 [Laminar air flow hoods not in a clean room for compounded sterile preparations] Institutional pharmacy use of air flow workbenches not in a buffer area for low risk level compounded sterile preparations [Institutional] A pharmacy holding an institutional pharmacy permit may utilize ISO class 5 laminar [air flow hoods] airflow workbenches not located in a [clean room may only be] buffer area to prepare low risk level compounded sterile preparations provided that the administration of such preparations commences within 12 hours of the preparation or as recommended by the manufacturer, whichever is less. Such workbenches shall be located in an area which is maintained under sanitary conditions and which is only traveled by persons engaging in the compounding of sterile preparations. [Such hoods shall be certified by an independent certification company prior to use when first installed or after being moved and at six-month intervals.] 13:39-11.11 Compounding immediate use compounded sterile preparations in an institutional pharmacy A pharmacy holding an institutional pharmacy permit may prepare non-hazardous immediate use compounded sterile preparations outside of an ISO class 5 laminar airflow workbench when the delay resulting from the use of the workbench would harm the patient, including situations in which the patient experiences a sudden change in clinical status. 13:39-[11.5]11.12 Pharmacist-in-charge [and permitholders'] responsibilities (a) The pharmacist-in-charge shall supervise all sterile [and/or non-sterile] compounding performed by pharmacy personnel. [For purposes of supervising sterile compounding, the] The pharmacist-in-charge shall be trained in aseptic manipulation skills. (b) The pharmacist-in-charge shall [have the responsibility, in that section of the pharmacy where sterile and/or non-sterile preparations are compounded,] be responsible for, at a minimum, the following: [1. Compounding of all preparations within the pharmacy or pharmacy satellite, including compounding of individual medication orders or prescriptions, the formulation of products in response to special drug needs, and batch compounding;] 1. Determining the procedural, environmental and quality control practices that are necessary for the risk levels he or she assigns to specific compounded sterile preparations; 2. Ensuring that the selected sterilization method both sterilizes and maintains the strength, purity, quality, and packaging integrity of the compounded sterile preparations; 3. Ensuring the placement of equipment (for example, refrigerators), devices (for example, computers and printers), and objects (for example, carts and cabinets) that are not essential to compounding in buffer areas and ante areas is dictated by their effect on the required environmental quality of air atmospheres and surfaces, which shall be verified by monitoring; [2.] 4. Storage of all materials pertinent to the compounding of sterile preparations, including drugs, chemicals, and biologicals, and the establishment of [specifications] specific procedures for procurement of the materials in accordance with State and Federal laws and regulations; [3.] 5. Ensuring that all packaging and labeling of all [drugs] compounded sterile preparations [with] in the pharmacy are performed under the immediate personal supervision of a pharmacist; [page=207] [4. Recording all transactions of the pharmacy as may be applicable to State, Federal and local laws and rules, as may be necessary to maintain accurate control over, and accountability for, all pharmaceutical materials;] [5.] 6. Ensuring that preparation and compounding of sterile preparations is performed only by [licensed] pharmacists who have been trained in aseptic manipulation skills, or by pharmacy technicians, interns, or externs who have been trained in aseptic manipulation skills working under the immediate personal supervision of a [licensed] pharmacist trained in aseptic manipulation skills; 7. Recording all transactions of the pharmacy as may be applicable to State, Federal, and local laws and rules, as may be necessary to maintain accurate control over, and accountability for, all pharmaceutical materials, and ensuring that policies and procedures exist with respect to the maintenance of the audit trail required pursuant to N.J.A.C. 13:39-11.20; [6. Ensuring that preparation and compounding of non-sterile preparations is performed only by licensed pharmacists or by pharmacy technicians, intern or externs working under the immediate personal supervision of a licensed pharmacist; and] 8. Ensuring that all pharmacists, pharmacy technicians, interns, and externs who compound sterile preparations are trained and evaluated consistent with the requirements of N.J.A.C. 13:39-11.16; [7.] 9. Establishing procedures for maintaining the integrity of the product and the manufacturer's control identity [of packaged material] when repackaging sterile products. [The] A pharmacist shall check all repackaging and shall initial the repackaging records [shall be initialed by the supervising pharmacist.]; 10. Disposal of all unused drugs and materials used in compounding sterile preparations, including antineoplastic agents and other hazardous substances, in accordance with accepted professional standards, and the Medical Waste Act, set forth at N.J.S.A. 13:1E-48.1 et seq., so as not to endanger the public health; 11. Ensuring that the compounding area and its contents and other areas where compounded sterile preparations are present are secured so as to prevent access by unauthorized personnel; 12. Ensuring that the pharmacy contains, in addition to the minimum reference library mandated in N.J.A.C. 13:39-5.8(a)1, references pertinent to compounding sterile preparations; 13. Ensuring that records are maintained which document, at least once daily, that appropriate refrigerator, freezer, if applicable, and room temperatures are maintained. Such records shall be maintained for no less than five years and shall be made available to the Board for inspection upon request; 14. Ensuring that all information required to be maintained as part of a pharmacy's patient profile record system pursuant to N.J.A.C. 13:39-7.19 or 9.19 is maintained for all compounded sterile preparations; 15. Ensuring that initial and ongoing multidisciplinary clinical monitoring and comprehensive care plans are maintained and readily available; and 16. Maintaining a policy and procedures manual detailing the pharmacy's standard operating procedures with regard to compounded sterile preparations, consistent with the requirements of N.J.A.C. 13:39-11.23, and maintaining a written quality assurance program, consistent with the requirements of N.J.A.C. 13:39-11.24. 13:39-[11.6]11.13 Pharmacy technicians, interns, and externs; required supervision (a) [Dispensing pharmacists] Pharmacists shall provide immediate personal supervision to pharmacy technicians, interns, or externs who are performing [delegated] sterile [and non-sterile preparation] compounding. The ratio of [dispensing] pharmacists to pharmacy technicians shall not exceed 1:2 at any given time unless all of the requirements of N.J.A.C. 13:39-[6.6(d) and (e)] 6.15 are met. 1. Supervision shall include, but is not limited to, the checking of each ingredient used, the quantity of each ingredient whether weighed, measured, or counted, and the finished label. (b) The [dispensing] pharmacist may delegate to pharmacy technicians, interns, or externs only the following tasks: recording of the prescription, selection of the drugs, container and diluent, [typing of labels] labeling, and compounding of preparations. The [dispensing] pharmacist shall ensure that each task has been performed correctly [in the dispensing process]. 13:39-11.14 Personnel cleansing and garbing requirements (a) All personnel who engage in compounding sterile preparations shall comply with the following requirements before entering the buffer area: 1. Personnel shall remove personal outer garments (for example, bandanas, coats, hats, jackets, scarves, sweater, vests), all cosmetics, and hand, wrist, and other visible jewelry or piercings (for example, earrings, or lip or eyebrow piercings); 2. The wearing of artificial nails or extenders is prohibited while working in the compounding area. Natural nails shall be kept neat and trimmed; 3. Personnel protective equipment shall be donned in the following order: i. Dedicated shoes or shoe covers; ii. Head and facial hair covers (for example, beard covers in addition to face masks); iii. Face masks; and iv. Eye shields, if required; 4. A hand and forearm cleansing procedure shall be performed. Personnel shall remove debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using either lint-free disposable towels or an electric hand dryer; and 5. Personnel shall wear non-shedding gowns with sleeves that fit snugly around the wrists and enclosed at the neck, that are designed for buffer area use. (b) Following the completion of all steps outlined in (a) above, and once inside the buffer area, personnel shall perform antiseptic hand cleansing, using a waterless alcohol-based surgical hand scrub with persistent activity following manufacturers' recommendations. Once hands are dried thoroughly, personnel shall don sterile gloves. Gloves shall be routinely inspected for holes, punctures, or tears, and shall be replaced immediately if any are detected. 1. Gloves become contaminated when they contact non-sterile surfaces during compounding activities. Disinfection of contaminated gloved hands may be accomplished by wiping or rubbing sterile 70 percent Isopropyl Alcohol (IPA) on all contact surface areas of the gloves and letting the gloved hands dry thoroughly. Routine application of sterile 70 percent IPA shall occur throughout the compounding process and whenever non-sterile surfaces (for example, vials, counter tops, chairs, and carts) are touched. (c) When compounding personnel exit the cleanroom during a work shift, the exterior gown may be removed and retained in the cleanroom if not visibly soiled, and may be re-donned during that same work shift only. Shoe covers, hair and facial hair covers, face masks/eye shields, and gloves, however, shall be replaced with new ones before re-entering the buffer area, and proper hand hygiene shall be performed, consistent with (a) and (b) above. 13:39-11.15 Cleaning and disinfection requirements for cleanroom, buffer area, and ante area (a) The cleanroom, buffer area, and ante area shall be cleaned and disinfected consistent with the following requirements: 1. All surfaces in laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators shall be cleaned and disinfected at the beginning of each work shift, before each batch preparation is started, after spills, and when surface contamination is known or suspected; 2. All counters, work surfaces, and floors shall be cleaned and disinfected daily; and 3. All walls, ceilings, and storage shelving shall be cleaned monthly. (b) All cleaning and disinfection shall be performed consistent with the standards established in Appendix II of USP 797, which is [page=208] incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org. 13:39-[11.7]11.16 Training and evaluation requirements [for compounding sterile preparations] (a) The pharmacist-in-charge and all [personnel] pharmacists, pharmacy technicians, interns, and externs involved in compounding sterile preparations shall have didactic and practical [or academic] training in sterile preparation compounding, including proper personnel cleansing and garbing, and cleaning and disinfecting the sterile compounding areas, [clean room] cleanroom technology, laminar flow technology, isolator technology, if applicable, and quality assurance techniques. Such training shall be documented for each person before that individual begins to compound sterile preparations and annually thereafter for all pharmacists, pharmacy technicians, interns, and externs who compound sterile preparations. That documentation shall be maintained by the permitholder for five years and made available to the Board upon request. (b) [The pharmacist in charge shall be responsible for ensuring that, prior] Prior to compounding sterile preparations and annually thereafter, all [personnel are trained and can successfully demonstrate:] pharmacists, pharmacy technicians, interns, and externs shall have passed a written test which demonstrates competency in all areas set forth in (a) above, and in the pharmacy's standard operating procedures with regard to compounding sterile preparations as set forth in the policy and procedure manual required to be maintained pursuant to N.J.A.C. 13:39-11.23. [1. Comprehensive knowledge of the pharmacy's standard operating procedures with regard to compounding sterile preparations as set forth in the policy and procedure manual required to be maintained pursuant to N.J.A.C. 13:39-11.13; 2. Familiarity with the necessary compounding techniques; and 3. Appropriate aseptic technique, which shall be proven by means of a test batch of culture media, media fill or the equivalent.] (c) [At least annually, the pharmacist in charge shall be responsible for testing] Testing of the aseptic technique of all [personnel] pharmacists, pharmacy technicians, interns, and externs involved in compounding sterile preparations, [by means of a test batch of culture media, media fill or the equivalent] shall be conducted consistent with the methods set forth in USP 797 concerning "Aseptic Manipulation Competency Evaluation," incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org, prior to compounding sterile preparations. Aseptic technique retesting shall be conducted annually for all personnel engaged in compounding low and medium risk level preparations and semi-annually for all personnel engaged in compounding high risk level preparations. [Test results shall be maintained for five years, and shall be made available for the Board's inspection upon request. Individuals who fail to demonstrate acceptable aseptic technique shall be prohibited from engaging in sterile preparation compounding until demonstrating acceptable technique by means of a test batch of culture media, media fill or the equivalent.] (d) All pharmacists, pharmacy technicians, interns, and externs engaging in the compounding of sterile preparations shall successfully complete an initial gloved fingertip/thumb sampling procedure prior to compounding sterile preparations. Gloved fingertip/thumb sampling shall be conducted annually for all personnel engaged in compounding low and medium risk level preparations and semi-annually for all personnel engaged in compounding high risk level preparations. (e) Individuals who fail the written test and/or the test of aseptic technique shall be prohibited from compounding sterile preparations until passing both tests. (f) All tests results shall be maintained by the permit holder for five years and shall be made available to the Board for inspection upon request. 13:39-[11.8]11.17 Batch preparation (a) Pharmacists and pharmacy technicians, interns, and externs, consistent with N.J.A.C. 13:39-11.13, may compound sterile [and non-sterile] preparations [consistent with the provisions of N.J.A.C. 13:39-11.6] in a quantity that is supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided the pharmacist: [can document a history of valid prescriptions subsequently received shortly thereafter or medication orders that have been generated solely within an established professional prescriber-patient-pharmacist relationship, and provided they maintain the prescription on file for all such products dispensed at the pharmacy as required by state law. The pharmacist shall document the batch preparation process in accordance with N.J.A.C. 13:39-11.9(d).] 1. Documents a history of valid prescriptions or medication orders subsequently received, within the beyond use dating time of each product, which have been generated solely within an established professional prescriber-patient-pharmacist relationship; 2. Maintains the prescription or medication order on file for all such products dispensed at the pharmacy; 3. Documents the batch preparation process, including selection of the drugs, container and diluent, lot numbers and expiration dates of the drugs, containers and diluents, if any, and verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling. Each batch shall be given a unique batch number to identify the specific batch; and 4. Ensures that the labeling requirements set forth at N.J.A.C. 13:39-11.21(a)1, 5, 7, 9, and 10 are satisfied. (b) Pharmacists and pharmacy technicians, interns, and externs, consistent with N.J.A.C. 13:39-11.13, may batch prepare compounded sterile preparations for use by a licensed prescriber in his or her practice without a prescription, pursuant to N.J.A.C. 13:39-11.18, provided the pharmacist: 1. Complies with all requirements of N.J.A.C. 13:39-11.18; and 2. Documents the batch preparation process in accordance with N.J.A.C. 13:39-11.20(c). 13:39-11.18 Compounded sterile preparations for prescriber practice use A pharmacy may prepare compounded sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice. 13:39-11.19 Stability criteria and beyond-use dating (a) For purposes of this section, stability means the extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding. (b) In the absence of supporting valid scientific sterility testing and stability information that is directly applicable to specific preparations, the following dates and times for storage and initiation of administration of the compounded sterile preparations shall apply, according to the preparations' assigned risk level, unless the manufacturer's package indicates a different stability time: 1. For low-risk level compounded sterile preparations, in the absence of passing a sterility test: i. Administration shall begin within 48 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius); ii. Administration shall begin within 14 days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius); iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius); and iv. For products prepared in an airflow workbench not located in a buffer area in accordance with N.J.A.C. 13:39-11.10, administration shall begin within 12 hours or less of preparation. 2. For medium-risk level compounded sterile preparations, in the absence of passing a sterility test: i. Administration shall begin within 30 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius); [page=209] ii. Administration shall begin within nine days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius); iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius). 3. For high-risk level compounded sterile preparations, in the absence of passing a sterility test: i. Administration shall begin within 24 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius); ii. Administration shall begin within three days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius); and iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius). 4. For immediate use compounded sterile preparations, administration shall begin no less than one hour following the start of preparing the compounded sterile preparation. (c) The administration dates and times established in (b) above may not be exceeded or extended for compounded sterile preparations without verifiable supporting valid scientific sterility and stability information that is directly applicable to the specific preparation or compound. (d) A pharmacist shall determine the beyond-use date for a compounded sterile preparation consistent with (b) above and assign an appropriate discard after date for the compounded sterile preparation. The discard after date shall appear on the label consistent with the requirements of N.J.A.C. 13:39-11.21. (e) Opened or needle-punctured single-dose containers of sterile products (for example, bags, bottles, syringes, and vials) used in the compounding of sterile preparations for immediate use in an institutional pharmacy pursuant to N.J.A.C. 13:39-11.11, shall be used within one hour if opened in worse than ISO class 5 air quality, and any remaining contents shall be discarded. (f) Single-dose vials used in the compounding of sterile preparations exposed to ISO class 5 or cleaner air quality may be used up to six hours after initial puncture. (g) Opened single-dose ampuls used in the compounding of sterile preparations shall not be stored for any period of time. (h) Opened or needle-punctured multiple-dose vials used in the compounding of sterile preparations shall be used within 28 days after initially entering the vial, unless otherwise specified by the manufacturer. 13:39-[11.9]11.20 Documentation; audit trail (a) [Consistent with the provisions of N.J.A.C. 13:39-11.5, the dispensing] The pharmacist shall ensure that compounded sterile preparations have been properly prepared, consistent with the assigned risk level of the preparation, labeled, controlled, stored, dispensed, and distributed in accordance with the provisions of this subchapter. [(b) The pharmacist in charge shall be responsible for ensuring that policies and procedures exist so that all aspects of the dispensing process set out in (d) below are documented and that the pharmacist responsible for each preparation can be identified. (c) On or after April 5, 2011, a pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or extern(s) involved, consistent with the requirements of this chapter, in the steps of the compounding process set out in (d) below. All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail. All entries to the audit trail made by a pharmacy technician, intern or extern shall be reviewed and approved by the pharmacist. When more than one pharmacist is involved in the steps of the compounding process, the unique and secure user identifier(s) of the pharmacist(s) responsible for the accuracy and appropriateness of each step shall be recorded in the audit trail. Audit trail documentation shall be generated at the time each step is performed. (d) Compounding steps which shall be documented are as follows: 1. Receipt of prescription or medication order; 2. Recording of prescription or medication order in the patient record profile system, pursuant to N.J.A.C. 13:39-11.15; 3. Correct selection of the drugs, container, and diluent prior to their being compounded; 4. Verification that all pharmacy sterile preparation compounding is performed within a ISO class 5 laminar air flow hood or ISO class 5 clean room and that proper aseptic procedures are being used at all times to prevent bacterial contamination of this product; 5. Verification that ingredients comply with the prescription or medication order; 6. Verification that the prescription or medication order label complies with the requirements of N.J.A.C. 13:39-11.10; and 7. Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies.] (b) A pharmacy shall maintain an audit trail for all compounded sterile preparations consistent with the requirements of N.J.A.C. 13:39-7.6. (c) A pharmacy shall maintain a compounding record for each compounded sterile preparation that contains the following information: 1. Selection of the drugs, container, and diluent prior to their being compounded, including documentation of lot numbers and expiration dates of the drugs, containers, and diluents, if applicable; 2. Verification that the ingredients comply with the prescription or medication order; 3. Verification that the prescription or medication order label complies with the requirements of N.J.A.C. 13:39-11.21; 4. Verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling; and 5. Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies. [(e) The audit trail information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for not less than five years from the date of the last entry in the record. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.] 13:39-[11.10]11.21 Information required to appear on prescription label (a) The dispensed container for any compounded sterile preparation shall bear a permanently affixed label with at least the following information: 1. The date and[, for sterile preparations, the] time prepared; 2. In the retail pharmacy only, the name of the prescriber; 3. The name of the patient; 4. Directions for use; 5. The name and strength or quantity of all active ingredients, and the name and volume of the diluent, vehicle, and base solution(s), if applicable; 6. The name, address, and telephone number of the pharmacy; 7. The phrase "use by" followed by the preparation's use by date and [, for sterile preparations, the use by] time (If no time is stated, it is presumed to be 11:59 P.M. of the stated use by date)[.]; 8. Any ancillary and cautionary instructions as needed; 9. As pertinent, a warning, consistent with applicable Federal and State law, that [cytotoxic products] antineoplastic agents and other hazardous substances are biohazardous; [and] 10. As pertinent, the requirements for proper storage[.]; and [page=210] 11. In a retail pharmacy, for those medications not dispensed pursuant to the requirements of N.J.A.C. 13:39-9, the prescription number. (b) For immediate use compounded sterile preparations, when the preparation is not administered by the person who prepared it, or its administration is not witnessed by the person who prepared it, the compounded sterile preparation shall be labeled consistent with the requirements of (a) above and shall also include the name or identifier of the person who prepared the compounded sterile preparation. 13:39-[11.12]11.22 Handling, packaging, and delivery (a) The pharmacy shall be responsible for the proper handling and packaging of compounded sterile preparations for delivery from the pharmacy to the patient in order to assure and maintain the integrity, efficacy, stability, and[, where applicable,] sterility[,] of these preparations. The pharmacist in charge shall ensure that: 1. [A reasonable effort is made to provide tamper-evident packing] Tamper-evident packaging is utilized; 2. [Retail delivery] Delivery is made from the pharmacy to the patient or patient care location within a reasonable time; and 3. Proper in-transit storage is provided consistent with product labeling. 13:39-[11.13]11.23 Policy and procedures manual [for compounded sterile preparations] (a) The [pharmacist in charge shall maintain a] pharmacy's policy and procedures manual [which] shall set forth in detail the [licensee's] pharmacy's standard operating procedures with regard to compounded sterile preparations. (b) The policy and procedures manual shall include policies and procedures governing the following: 1. A risk-management program [(]including, but not limited to, [incident report procedures, an adverse drug reaction system, and a product contamination system)] documentation of incidents, adverse drug reactions, and product contamination; 2. Security measures ensuring that the premises where compounded sterile drugs are present are secured, so as to prevent access by unauthorized personnel; 3. Equipment; i. Procedures for use; and ii. Documentation of appropriate certifications; 4. [Sanitation] Cleaning and disinfecting standards and procedures, consistent with the requirements of N.J.A.C. 13:39-11.15; 5. Reference materials as set out in N.J.A.C. 13:39-5.8 and [11.24] 11.12(b)11; 6. Information concerning drug: i. Preparation; ii. Storage and handling; iii. Dispensing; iv. Labeling; v. Delivery; and vi. Destruction, recalls, and returns; 7. Patient recordkeeping as set forth in N.J.A.C. 13:39-[11.15]11.12(b)14; 8. Handling, dispensing, and documentation of investigational new drugs; 9. A quality assurance program as set forth in N.J.A.C. 13:39-[11.14]11.24; 10. Verification of training and competency guidelines as set forth in N.J.A.C. 13:39-[11.7]11.16; 11. Compounding process validation; 12. Documentation as set forth in N.J.A.C. 13:39-[11.9]11.20; 13. Description of appropriate garb and garbing procedures, consistent with the requirements of N.J.A.C. 13:39-11.14; 14. Conduct guidelines for personnel in the [controlled areas] clean room; 15. Personnel responsibilities; 16. Patient education [(retail patients)]; 17. Protocol and procedures to maintain the integrity of the interior work area of the laminar [air flow hoods] airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets; and 18. Written procedures in compliance with the Occupational Safety and Health Administration standards for handling small and large spills of antineoplastic agents and other hazardous substances. (c) [The pharmacist in charge shall review at least every two years and, if necessary, amend the policy and procedure manual as needed.] The policy and procedures manual shall be reviewed, at a minimum, once every 24 months and shall be updated, on a continuous basis, to reflect current practice. Documentation of the review shall be made available to the Board upon request. 13:39-[11.14]11.24 Quality assurance program [for compounded sterile preparations] [(a) This section shall apply both to commercially available sterile drug products that are dispensed to patients without compounding or other manipulation, and to sterile preparations which, prior to dispensing, have been in any way repackaged, reconstituted, diluted, admixed, blended, or otherwise manipulated (collectively referred to as "compounded").] [(b)] (a) The [dispensing pharmacist shall ensure that the compounded sterile preparation retains its quality attributes within acceptable limits through a written] pharmacy's quality assurance program[. The quality assurance program] shall require [at least], at a minimum, that: 1. A reasonable effort shall be made by the [dispensing] pharmacist to assure that compounded sterile preparations shall be kept under appropriate controlled conditions at the location of use by providing adequate labeling and verbal or written instructions regarding proper storage and administration as set forth by the product manufacturer, with each compounded sterile preparation dispensed; 2. The quality assurance program encompasses all phases of sterile compounding[, including preparation, distribution, storage, administration, and directions for use] for each unique type of [product] compounded sterile preparation dispensed; 3. After the preparation of every admixture, the contents of the container are thoroughly mixed and then visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, or any other defects, and the accuracy and thoroughness of labeling; 4. All pharmacists, pharmacy technicians, interns, and externs involved in compounding sterile preparations shall have their aseptic technique tested consistent with the requirements of N.J.A.C. 13:39-11.16; [3.] 5. All [compounding processes representative of all types of manipulations, products and batches must be sterile tested and validated at least every 12 months] high-risk level compounded sterile preparations that are prepared in groups of more than 25 identical individual single-dose packages (for example, ampuls, bags, syringes, vials), or in multiple-dose vials for administration to multiple patients, or that are exposed longer than 12 hours at two degrees to eight degrees Celsius and longer than six hours at warmer than eight degrees Celsius before they are sterilized, and all compounded sterile preparations whose beyond use date has been exceeded, shall be tested to ensure that they are sterile before they are dispensed or administered. The USP membrane filtration method shall be used where feasible. Another method may be used if verification results demonstrate that the alternative is at least as effective and reliable as the membrane filtration method or the USP direct inoculation of the culture medium method, consistent with the standards set forth in USP 797 concerning "Sterility Testing" incorporated herein by reference, as amended and supplemented, and available for purchase at the United States Pharmacopeia website, www.usp.org. i. When high-risk level compounded sterile preparations are dispensed before receiving the results of the sterility tests outlined in (a)4 above, the written quality assurance procedure shall require daily observation of the incubating test specimens and immediate recall of the dispensed compounded sterile preparations when there is any evidence of microbial growth in the test specimens. The patient and the physician of the patient to whom a potentially contaminated compounded sterile preparation was administered shall be notified [page=211] immediately of the potential risk. Positive sterility tests shall require rapid and systematic investigation of aseptic technique, environmental control, and other sterility assurance controls in order to identify sources of contamination and to take corrective action. ii. All high-risk level compounded sterile preparations, except those for inhalation and ophthalmic administration, shall be tested to ensure that they do not contain excessive bacterial endotoxins. [4.] 6. Air and surface sampling for microbial organisms in ISO class 5 primary engineering controls, such as laminar [air flow hoods] airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets, and in all other ISO classified areas [and ISO class 6 clean rooms] is done [twice annually] once every six months and at any time when microbial contamination is suspected [pursuant to United States Pharmacopoeia/National Formulary guidelines]; 7. Pressure differential monitoring shall be conducted consistent with the requirements of N.J.A.C. 13:39-11.4(d). A pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante area and between the ante area and the general environment outside the cleanroom. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be at least daily) or by a continuous recording device; [5.] 8. Laminar [air flow hoods] airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets shall be certified every six months, and every time they are moved, by an independent certification company to ensure that these primary engineering controls meet appropriate ISO classifications; [6.] 9. [The ISO class 6 clean room and ISO class 7 anteroom shall be certified every six months by an independent certification company; and] A cleanroom shall be certified by an independent certification company every six months and whenever the room or a primary engineering control in the room is relocated or altered, or whenever major service to the facility is performed to ensure that the cleanroom meets appropriate ISO classifications. Such certifications shall be performed consistent with procedures outlined in the Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding Facilities (CAG0003-2006), incorporated herein by reference, as amended and supplemented, and which may be found at the CETA website, www.cetainternational.org, specifically, www.cetainternational.org/reference/CETAAsepticCompoundingCertificationGuide.pdf; and [7. All unused drugs and materials used in the compounding of sterile preparations, including antineoplastic agents, are disposed of properly in accordance with accepted professional standards and applicable laws, including the Medical Waste Act (N.J.S.A. 13:1E-48.1 et seq., P.L. 1989, c.34).] 10. Whenever test results indicate that the cleanroom or any primary engineering controls do not meet the standards established in this section, the pharmacy shall immediately cease using the cleanroom or primary engineering control that is out of compliance until such time that the cleanroom and/or the primary engineering control meets the requisite standards. Test results indicating non-compliance with the requisite standards shall require re-evaluation of all procedures associated with the production of compounded sterile preparations in the impacted cleanroom or primary engineering control and documentation with respect to the period of time that the cleanroom and/or primary engineering control was out of compliance. SUBCHAPTER 11A. COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES 13:39-11A.1 Purpose and scope The rules in this subchapter regulate the practice of non-sterile compounding and shall apply to all retail and institutional pharmacies that compound and dispense non-sterile preparations. This subchapter establishes standards for the quality and control of processes, components and environments associated with compounded non-sterile preparations, and for the skill and knowledge of pharmacy personnel who prepare compounded non-sterile preparations. The requirements in this subchapter establish minimum good compounding practices that will enhance a pharmacist's ability to compound non-sterile preparations that are of acceptable strength, quality, and purity. 13:39-11A.2 Definitions The following words and terms, when used in this subchapter, shall have the following meanings: "Compounding" means the preparation, mixing, assembling, packaging, and labeling of a drug or device as the result of a practitioner's prescription or medication order or initiative based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescriptions or medication orders based on routine, regularly observed prescribing patterns. "Compounding pharmacist" means a pharmacist who performs or supervises any part of the compounding process.