In Huerta (2018 case) The Court of Appeal affirmed the judgment for defendant in an action alleging several violations of Fair Employment and Housing Act (FEHA; Government Code, section 12900 et seq.), but it reversed the trial court’s post judgment order awarding defendant $50,000 in costs and expert witness fees under Code of Civil Procedure section 998 because the trial court found that plaintiff’s action was not frivolous and denied defendant’s request for attorney fees, expert fees and costs under Government Code section 12965(b). For litigation that predates the application of the amended version of section 12965(b) (effective on January 1, 2019), the Court of Appeal ruled that section 998 does not apply to nonfrivolous FEHA actions and therefore reversed the order awarding defendant costs and expert witness fees under section 998.
CONNECTED DEVICES IN HEALTHCARE FDA LAWS: CLINICAL GRADE WEARABLES FOR IMPROVING PATIENT OUTCOMES
December 4-5, 2017 • Westin San Diego • San Diego, CA
Overview of FDA Regulatory Compliance Requirements — Spotlight on
Wearable Devices
- Overview of FDA regulatory compliance requirements of wearable devices including hearing aids, defibrillator vests, radiation- emitting devices, watches, glasses and shoes
- Medical device registration and FDA tracking
- Risk-benefit analysis, preclinical studies, biocompatibility and biological evaluation
- Classification, premarket submission
Al Mohajerian, Mohajerian APLC
http://www.cbinet.com/sites/default/files/brochures/fc17214_brochure.pdf
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT (DSHEA) OF 1994, DEFINED DIETARY SUPPLEMENT AND ADDED SPECIFIC LABELING REQUIREMENTS FOR DIETARY SUPPLEMENTS.
The Nutrition Labeling and Education Act of 1990 (NLEA) amended Food, Drug & Cosmetic Act, requiring food and dietary supplements to have nutrition labeling.
Dietary Supplement Health and Education Act (DSHEA) of 1994, defined Dietary Supplement and added specific labeling requirements for dietary supplements.
In 1997, several key regulations for statement of identity, nutrition labeling, ingredient labeling, nutrition content and health claims for dietary supplements were implemented.[1]
The 1997 Food and Drug Administration Modernization Act authorizes health claims based on an authoritative statement of a scientific body of the U.S. government with official responsibility for public health protection or research directly related to human nutrition, or the National Academy of Sciences. Such claims may be used after submission of a health claim notification to FDA.
Dietary supplements are classified as food products, but DSHEA stipulates that such products must be labeled as “dietary supplements” and be sold in the form of pills, capsules, tablets, gelcaps, liquids, powders, or other forms, and not be represented for use as conventional foods. Supplements also cannot be marketed as the only item in a meal or diet.
As of March 1999, dietary supplement packages must bear a “Supplement Facts” panel, similar to the “Nutrition Facts” panel mandated for food labels by the Nutrition Labeling and Education Act (NLEA) of 1990. The purpose of this labeling is to provide information about nutrients and other dietary ingredients. The label must list all dietary ingredients and the Daily Values (DV) of the amounts contained in a serving. If no DV has been established for a dietary ingredient, this must be indicated. [2]
If a blend of ingredients is proprietary, the total quantity of ingredients per serving must be stated rather than the amount of each individual ingredient in the blend. If an ingredient is an herbal product, the part of the plant (such as the root or leaf) from which the ingredient is derived must be identified. The common name of the botanical as listed in Herbs of Commerce (American Herbal Products Association, Silver Spring, Md.) may be used; if a botanical is not listed in the book, the Latin binomial name (e.g., Echinacea augustifolia DC) must be used. The following information also must appear on the label: statement of identity, which identifies the contents of the product; net quantity of contents; ingredient list (in descending order by weight); and the name and address of the manufacturer, packer, or distributor (FDA, 1997c). [3]
Under DSHEA, however, dietary supplement ingredients may be sold without undergoing a formal FDA approval process. Although the supplement manufacturer is not required to provide rigorous scientific evidence of safety or efficacy, the manufacturer should be able to provide information to support any labeling claims.[4]
Under the law, claims that are allowed to be used on food and dietary supplement labels fall into three categories: nutrient content claims, health claims and structure/function claims. Disease-related claims are generally not permitted for dietary supplements.
[1] See FDA website, Guidance for Industry, Food, Guidance and Regulation, Guidance Documents and Regulatory Information by Topic, A Dietary Supplement Labeling Guide.
[2] IFT Network, Dietary Supplements: Nutritional and Legal Considerations, July 1, 1999.
[3] IFT Network, Dietary Supplements: Nutritional and Legal Considerations, July 1, 1999
[4] IFT Network, Dietary Supplements: Nutritional and Legal Considerations, July 1, 1999.
IS A 503(B) PHARMACY ALLOWED TO PREPARE PATIENT SPECIFIC MEDICATIONS?
Under the FDA rules, the answer is yes:
21 U.S.C. 353b provides, inter alia,
“(d)(4)(A) The term “outsourcing facility” means a facility at one geographic location or address that–
(i) is engaged in the compounding of sterile drugs;
(ii) has elected to register as an outsourcing facility; and
(iii) complies with all of the requirements of this section.
(B) An outsourcing facility is not required to be a licensed pharmacy.
(C) An outsourcing facility may or may not obtain prescriptions for identified individual patients. (emphasis added)”
“….Section 503(b) establishes ‘Outsourcing Facilities.’ Outsourcing facilities can provide compounded sterile drugs without patient-specific prescriptions. “Outsourcing facilities can provide patient-specific and non-patient-specific medications.”1
“Section 503(a) applies to pharmacies that compound patient-specific prescriptions, such as patient-specific intrathecal medications…. Pharmacies that practice under this business model are regulated by their respective State Boards of Pharmacy2.
“State regulations can also complicate the definition of whether pharmacies are in compliance with “patient-specific” only when compounding for one patient…” 3”
Last in February 2015, in the California legislature, Senator Mike Morell introduced
Senate Bill 619, which was sponsored by the California Board of Pharmacy. This Senate Bill has not been enacted into law. On February 1, 2016, Senate Bill 619 was returned to the Secretary of the Senate, pursuant to Joint Rule 56.4 If it had been enacted, it would have prevented a 503(b) pharmacy from preparing patient specific medications.
Senate Bill 619 has passed the California Senate but it has not been enacted into law. The Bill stated: “California licensing requirements for a new category of prescription drug compounding entity called an outsourcing facility. This bill will prohibit a licensed outsourcing facility from filling patient specific prescriptions. This bill will create new licensure requirements, specific to the state of California, for in state and out of state outsourcing facilities doing business within and across state lines. These new requirements will prohibit an outsourcing facility to be located in the same licensed premises as a pharmacy, therefore only allowing outsourcing facilities to distribute compounded drugs for non-patient specific prescriptions. Since the FDA has yet to release specific federal requirements for outsourcing facilities, this bill anticipates future federal requirements and creates California specific standards by which licensed outsourcing facilities must comply.5”
Although this Senate Bill is not enacted into law, it could be enacted soon.
The Board of Pharmacy in California will continue to seek to regulate outsourcing facilities or 503(b) facilities.
In conclusion, 503(b) pharmacies or outsourcing facilities may under the FDA rules legally prepare patient specific medications. Consult with our firm or your counsel before making any decisions as the law in this field keeps changing. This article is designed for general information only. The information presented should not be construed to be formal legal advice nor the formation of a lawyer/client relationship
1 Hartley Medical, “Revisiting HR3204: the Drug Quality and Security Act of 2013”, William Stuart.
2 Hartley Medical, “Revisiting HR3204: the Drug Quality and Security Act of 2013”, William Stuart.
3 Pharmaceutical North America, Inc. “What is Patient-Specific Compounding? The Gray Areas may Surprise Pharmacists, February 16, 2016.
4 Joint Rules of the Senate and Assembly, 2015-2016 Regular Session,4 Joint Rule 56 states: “Bills introduced in the first year of the regular session and passed by the house of origin on or before the January 31st constitutional deadline are ‘carryover bills.”” Immediately after January 31, bills introduced in the first year of the regular session that do not become “carryover bills” shall be returned to the Chief Clerk of the Assembly or Secretary of the Senate, respectively. Notwithstanding Rule 4, as used in this rule “bills” does not include constitutional amendments,” Joint Rule 4 states: “Whenever the word “bill” is used in these rules, it includes any constitutional amendment, any resolution ratifying a proposed amendment to the United States Constitution, and any resolution calling for a constitutional convention.”
5 Senate Bill 619 on outsourcing facilities.
A STERILE COMPOUNDING PHARMACY LICENSE
Violation of California Regulations
Cal. Bus. & Prof. Code § 4300 provides, inter alia,
(a) A pharmacy shall not compound sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board pursuant to this section. The license shall be renewed annually and is not transferable.
(b) A license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy and shall be issued only to the owner of the pharmacy licensed at that location.
California makes clear that compounding limitations include: a valid prescription for an individual patient, a limited quantity, of not more than a 72 hour supply, and retail pharmacies are excluded.
16 CFR §1735.2. Compounding Limitations and Requirements, provides:
(a) Except as specified in (b) and (c), no drug product shall be compounded prior to receipt by a pharmacy of a valid prescription for an individual patient where the prescriber has approved use of a compounded drug product either orally or in writing. Where approval is given orally, that approval shall be noted on the prescription prior to compounding.
(b) A pharmacy may prepare and store a limited quantity of a compounded drug product in advance of receipt of a patient-specific prescription where and solely in such quantity as is necessary to ensure continuity of care for an identified population of patients of the pharmacy based on a documented history of prescriptions for that patient population.
(c) A “reasonable quantity” as used in Business and Professions Code section 4052(a)(1) means that amount of compounded drug product that:
(1) is sufficient for administration or application to patients in the prescriber’s office, or for distribution of not more than a 72-hour supply to the prescriber’s patients, as estimated by the prescriber; and
(2) is reasonable considering the intended use of the compounded medication and the nature of the prescriber’s practice; and
(3) for any individual prescriber and for all prescribers taken as a whole, is an amount which the pharmacy is capable of compounding in compliance with
pharmaceutical standards for integrity, potency, quality and strength of the compounded drug product.
(f) The pharmacist performing or supervising compounding is responsible for the integrity, potency, quality, and labeled strength of a compounded drug product until it is dispensed.
h) Health care entity means any person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy or any wholesale distributor. Except as provided in § 203.22(h) and (i) of this chapter, a person cannot simultaneously be a “health care entity” and a retail pharmacy or wholesale distributor.