What changed in this filing

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Item 1A. Risk Factors

2020-11-09 compared with 2020-08-10 · 57 added, 32 removed, 135 unchanged (40% of the section changed)

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You should consider all of the factors described in this section as well as the risk factors and the other information

in our Quarterly Report on Form 10-Q for the three months ended March 31, 2020 and our Annual Report on Form 10-K including

in our Quarterly Report on Form 10-Q for the three months ended September 30, 2020 and our Annual Report on Form 10-K including

our audited financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition

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the market price of our common stock would likely decline and you may lose all or part of your investments.

risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Additional risks and

uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

COVID-19 pandemic has had an adverse effect on our business and results of operations and is expected to continue to have further

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compounding, dispensing, reimbursement, marketing and labeling of prescription drugs and related services including;

and/or state regulation affecting the pharmacy and pharmaceutical industries, including state pharmacy licensure and registration

or permit standards;

state regulation affecting the pharmacy and pharmaceutical industries, including state pharmacy licensure and registration or

permit standards;

rules and regulations issued pursuant to HIPAA and other state and federal laws related to the use, disclosure

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to our business model and operations and/or could require us to incur significantly increased costs to comply with such regulations.

July 30, 2020, FDA issued a notice for comments related to certain bulk drug substances to be removed from the 503B Bulk’s

List (or Category 1 List).

Included in this notice for comment were certain bulk drug substances which we currently use in some

of our compounded products.

July 30, 2020, the FDA issued a notice for comments related to certain bulk drug substances to be removed from the 503B

Bulk’s List (or Category 1 List).

Included in this notice for comment were certain bulk drug substances which we currently

use in some of our compounded products.

In the event one or more of these bulk substances are ultimately removed from the Category

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we use are removed from the 503B Bulk’s List, this may result in a disruption in our operations, revenues and cash flows.

loan under the Paycheck Protection Program may not be forgiven or may subject us to challenges and investigations

regarding qualification for the loan.

October 27, 2020, the FDA announced availability of a final Memorandum of Understanding, Addressing Certain Distributions

of Compounded Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug

Administration (the “MOU”).

The MOU describes the responsibilities of a state board of pharmacy, or other appropriate

state agency that chooses to sign the MOU, in investigating and responding to complaints related to drug products compounded in

such state and distributed outside such state and in addressing the interstate distribution of inordinate amounts of compounded

human drug products.

Additionally, as part of the MOU, FDA refined the definition of “inordinate amount,” a threshold

for certain information identification and sharing which does not place a limit on the distribution of compounded human drug products

interstate by a pharmacy located in a state that has entered into the MOU.

Section 503A of the FDCA sets a five percent limit

on compounded drugs distributed outside the state by a pharmacist, pharmacy or physician located in a state that has not entered

into the MOU.

have 365 days to sign the MOU, before the FDA intends to enforce the five percent limit described in Section 503A of the

FDCA in states that have not signed the MOU.

Our pharmacy is based in the state of New Jersey, and we believe the state board

of pharmacy in New Jersey will sign the MOU and as a result, our operations will not be materially affected by the MOU.

In the event New Jersey does not sign the MOU, our pharmacy that operates under Section 503A may be materially affected and we

will transition as many prescription orders as possible to our outsourcing facility, which is not subject to the MOU.

loan under the Paycheck Protection Program may not be forgiven or may subject us to challenges and investigations regarding qualification

for the loan.

April 2020, we received the PPP Loan, which was established under the CARES Act in the principal amount of $1,967,000.

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costs, rent, and utility costs over the allowable measurement period following receipt of the loan proceeds.

The SBA continues to develop and issue

new and updated guidance regarding the PPP Loan application and forgiveness process, including guidance regarding required borrower

certifications and requirements for forgiveness of loans made under the program.

Given the evolving nature of the guidance and

depending upon our ability to use the loan proceeds for qualifying expenses, we cannot give any assurance that our PPP Loan will

be forgiven in whole or in part.

SBA continues to develop and issue new and updated guidance regarding the PPP Loan application and forgiveness process, including

guidance regarding required borrower certifications and requirements for forgiveness of loans made under the program.

evolving nature of the guidance and depending upon our ability to use the loan proceeds for qualifying expenses, we cannot give

any assurance that our PPP Loan will be forgiven in whole, in part, or that we will apply for forgiveness.

Additionally,

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and access to alternative forms of capital, and believe that we satisfied all eligibility criteria for the PPP Loan and that our

receipt of the PPP Loan is consistent with the broad objectives of the Paycheck Protection Program of the CARES

Act, the certification described above does not contain any objective criteria and is subject to interpretation.

the SBA has stated that it is unlikely that a public company with substantial market value and access to capital markets will

be able to make the required certification in good faith.

The lack of clarity regarding loan eligibility under the program has

resulted in significant media coverage and controversy with respect to public companies applying for and receiving loans.

despite our good faith belief that we satisfied all eligibility requirements for the PPP Loan, we are found to have been ineligible

to receive the PPP Loan or in violation of any of the laws or regulations that apply to us in connection with the PPP Loan, including

the False Claims Act, we may be subject to penalties, including significant civil, criminal and administrative penalties and would

be required to repay the PPP Loan.

In the event that we seek forgiveness of all or a portion of the PPP Loan, we will also be

required to make certain certifications which will be subject to audit and review by governmental entities and could subject us

to significant penalties and liabilities if found to be inaccurate, including being required to repay the PPP Loan.

In addition, our receipt of the PPP Loan may result in adverse publicity and damage to our reputation, and a review or audit by

the SBA or other government entity or claims under the False Claims Act could consume significant financial and management

Any of these events could materially harm our business, results of operations and financial condition.

receipt of the PPP Loan is consistent with the broad objectives of the Paycheck Protection Program of the CARES Act, the certification

described above does not contain any objective criteria and is subject to interpretation.

In addition, the SBA has stated that

it is unlikely that a public company with substantial market value and access to capital markets will be able to make the required

certification in good faith.

The lack of clarity regarding loan eligibility under the program has resulted in significant media

coverage and controversy with respect to public companies applying for and receiving loans.

If, despite our good faith belief

that we satisfied all eligibility requirements for the PPP Loan, we are found to have been ineligible to receive the PPP Loan

or in violation of any of the laws or regulations that apply to us in connection with the PPP Loan, including the False Claims

Act, we may be subject to penalties, including significant civil, criminal and administrative penalties and would be required

to repay the PPP Loan.

In the event that we seek forgiveness of all or a portion of the PPP Loan, we will also be required to

make certain certifications which will be subject to audit and review by governmental entities and could subject us to significant

penalties and liabilities if found to be inaccurate, including being required to repay the PPP loan.

In addition, our receipt

of the PPP Loan may result in adverse publicity and damage to our reputation, and a review or audit by the SBA or other government

entity or claims under the False Claims Act could consume significant financial and management resources.

Any of these events

could materially harm our business, results of operations and financial condition.

disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

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affect our ability to attain our operating goals on schedule and on budget.

Unregistered Sales of Equity Securities and Use of Proceeds

Defaults Upon Senior Securities

Mine Safety Disclosures

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors